Books by Subject
- 90 days to success in grant writing — Human error : causes and control (100)
- Human medical research : ethical, legal and socio-cultural aspects — Role of theory in advancing 21st century biology : catalyzing transformative research : report of Committee on Defining and Advancing the Conceptual Basis of Biological Sciences in the 21st Century, National Research Council. (100)
- Role of purchasers and payers in the clinical research enterprise — Yeast as tool in cancer research (46)
- 2010 ProQuest SafariKachinske, Timothy; Kachinske, Judith.Getting started as a Grant writer -- Finding and securing a Grant-writing position -- Expertise -- Research -- Managing relationships -- Writing -- Organizing information -- Queries and short proposals -- Proposals for projects, programs, or bricks and mortar -- Proposals for endowment support -- Federal Grants -- Managing Grant awards.
- 2012 CRCnetBASEChin, Richard Y.1. Background -- 2. Conventional statistics -- 3. Statistics used in adaptive clinical trials -- 4. Specific requirements for adaptive trials -- 5. Adaptive randomization and allocation -- 6. Sample size reestimation -- 7. Traditional dosing -- 8. Adaptive dosing -- 9. Interim analysis and adaptive termination of study and study arms -- 10. Adaptive changes in study design and decision rules -- 11. Seamless designs and adaptive clinical trial conduct -- 12. Analysis and interpretation of results.
- 2007 CRCnetBASEChow, Shein-Chung; Chang, Mark.
- 2012 CRCnetBASEChow, Shein-Chung; Chang, Mark.Protocol amendment -- Adaptive randomization -- Adaptive hypotheses -- Adaptive dose-escalation trials -- Adaptive group sequential design -- Statistical tests for adaptive seamless designs -- Adaptive sample size adjustment -- Two-stage adaptive design -- Adaptive treatment switching -- Bayesian approach -- Biomarker adaptive trials -- Target clinical trials -- Sample size and power estimation -- Clinical trial simulation -- Regulatory perspectives : a review of FDA draft guidance.
- 2012 Thieme BookAlt, Volker; Bhandari, Mohit; Robioneck, Bernd; Schemitsch, Emil H.; Sprague, Sheila.1. Factorial Randomized Trials -- Summary -- Introduction -- Randomized clinical trial design strategies with multiple interventions -- Selecting a factorial randomized design -- Conclusion -- 2. Expertise-based randomized trials -- Summary -- Introduction -- Conventional RCT design -- Expertise-based RCT design -- Challenges of expertise-based RCTs -- Independent assessor -- Balanced and consecutive or random contributions to screening pool -- Perceived equivalence between practices -- Conclusion -- 3. Randomization systems and technology -- Summary -- Introduction -- Methods of patient allocation -- Other considerations -- Conclusion -- 4. Blinding and concealment -- Summary -- Introduction -- Concealment -- Blinding -- Conclusion -- 5. Composite outcome in orthopaedics: understanding the concepts -- Summary -- Introduction -- Rationale for use of a composite outcome -- Limitations of using composite outcomes -- Guidelines for creating a "good" composite outcome -- Reporting and interpreting composite outcomes -- Conclusion -- 6. Adjudication of outcomes-systems and approaches -- Summary -- Introduction -- Importance of adjudication -- Process of adjudication -- Existing methods of adjudication -- Web-based adjudication -- Conclusion -- 7. Subgroup analyses -- Summary -- Introduction -- Subgroup analysis defined -- Design of a subgroup analysis -- Reporting -- Interpretation -- Conclusion -- 8. Trial management-advance concepts and systems -- Summary -- Introduction -- Phases of clinical trials -- Common considerations in conducting a clinical trial -- Trial committees -- The search for funding -- Conclusion 9. Case-control studies -- Summary -- Introduction -- Definition of a case-control study -- Conclusion -- 10. Cohort studies -- Summary -- Introduction -- Cohort studies in the hierarchy of evidence -- Types of cohort study designs -- Methods for reducing confounding and assessing causality -- A checklist to evaluate or improve the strength of evidence -- Conclusion --; 11. Survey Design -- Summary -- Introduction -- Identifying a research question -- Survey development -- Survey design -- Using exiting surveys -- survey validataion -- Pilot testing -- Survey administration -- Ethical considerations -- Financial considerations -- Conclusion -- 12. Qualitative studies -- Summary -- Introduction -- What is qualitative research? -- How is qualitative research done? -- Conclusion -- 13. Economic analysis -- Summary -- Introduction -- Theoretical background -- Conducting health economics studies -- Conclusion -- 14. Literature searches -- Summary -- Introduction -- When to conduct a literature search -- How to conduct a literature search -- Study selection -- Assessing methodological quality of studies -- Data extraction and analysis -- Conclusion -- 15. Summary -- Introduction -- the P value does not assess the magnitude of a treatment effect -- The challenge of comparing results across studies -- Types of effect sizes -- Confidence intervals for effect sizes -- Use of effect size in meta-analysis -- Conclusion -- 16. Fixed effects versus random effects -- Summary -- Introduction -- the data pool: fixed effects versus random effects -- Deciding which model to use -- Conclusion -- 17. Heterogeneity -- Summary -- Introduction -- Heterogeneity defined -- Identifying heterogeneity -- Dealing with heterogeneity -- Conclusion -- 18. Uncovering publicatiion bias -- Summary -- Introduction -- Authors and publication bias -- Detecting and adjusting for publication bias -- Minimizing the effect of publication bias -- A possible solution: trial registers -- Conclusion -- 19. Statiecal pooling - programs and systems -- Summary -- Introduction -- Selectin the appropriate programs and systems: factors to consider --Review of programs and systems -- Types of programs and systems -- Recommendations -- Conclusion -- 20. Meta-analysis of observational studies -- Summary -- Introduction -- The observational data dilemma -- Conclusion -- 21. Meta-regression -- Summary -- Introduction -- Heterogeneity and meta-regression -- Meta-regression mechanics -- Interpreting a meta-regression -- Limitations of meta-regression -- Conclusion -- 22. Preparing a statistical analysis plan -- Summary -- Introduction -- Data management -- Statistical procedures -- Data safety and monitoring board -- Sample size -- Interim analysis -- Reports to investigators -- Sensitivity analysis -- Tables of presentation and publication -- Software -- Reporting guidelines -- General policies -- Privacy considerations -- Apendices -- What is in the literature about SAP? -- Conclusion --; 24. Survival analysis -- Summary -- Introduction -- Documenting time-to-event (survival) data -- the rationale for time-to-event (survival) analysis -- Methods for survival analysis -- Comparing groups -- Practical considerations in the desin of time-to-event studies -- Conclusion -- 25. Interim analyses in randomized trials -- Summary -- Introduction -- Interim analysis defined -- Design of an interim analysis -- Data monitoring committees -- Consequences of stopping early for benefit -- Conclusion -- 26. Conflicts of interest reporting -- Summary -- Introduction -- Legal implications -- Types of conflict of interest -- Who should disclose conflicts of interest? -- When must conflicts of interest be disclosed? -- Guidelines and recommendations for disclosure -- Why must personal financial interests be disclosed? -- Alternatives to disclosure policies -- Conclusion -- 27. Authorship-modern approaches and reporting -- Summary -- Introduction -- Academic stream -- Educational stream -- Industrial stream -- Popular media stream -- Conclusion -- 28. Randomized trials reporting checklists -- Summary -- Introduction -- Consort statement -- Nonpharmacological trials -- NPT extension to consort statement -- CLEAR NPT -- Conclusion -- 29. Observational studies reporting checklists -- Summary -- Introduction -- Checklist for observational studies: the STROBE statement -- Guide to investigators: how to used the STROBE statement -- The STROBE statement: explanations of checklist items -- Conclusion -- 30. Meta-analysis reporting checklists -- Summary -- Introduction -- Meta-analysis reporting checklists -- Conclusion -- Resources and contacts for surgical research -- Summary -- Introduction -- Mentorship -- Graduate programes -- Online courses -- Textbooks and journals -- Courses and workshops -- Contract research organizations -- Conclusion -- Glossary of terms.
- 2014 SpringerGange, A. C.; Verma, Vijay.In recent years there has been significant attention paid on the endophytic research by various groups working within this domain. Mutualistic endophytic microbes with an emphasis on the relatively understudied fungal endophytes are the focus of this special book. Plants are associated with micro-organisms: endophytic bacteria and fungi, which live inter- and intra-cellularly without inducing pathogenic symptoms, but have active biochemical and genetic interactions with their host. Endophytes play vital roles as plant growth promoters, biocontrol agents, biosurfactant producers, enzymes and secondary metabolite producers, as well as providing a new hidden repertoire of bioactive natural products with uses in pharmaceutical, agrochemical and other biotechnological applications. The increasing interest in endophytic research generates significant progress in our understanding of the host-endophyte relationship at molecular and genetic level. The bio-prospection of microbial endophytes has led to exciting possibilities for their biotechnological application as biocontrol agent, bioactive metabolites, and other useful traits. Apart from these virtues, the microbial endophytes may be adapted to the complex metabolism of many desired molecules that can be of significant industrial applications. These microbes can be a useful alternative for sustainable solutions for ecological control of pests and diseases, and can reduce the burden of excess of chemical fertilizers for this purpose. This book is an attempt to review the recent development in the understanding of microbial endophytes and their potential biotechnological applications. This is a collection of literature authored by noted researchers having signatory status in endophytic research and summarizes the development achieved so far, and future prospects for further research in this fascinating area of research.
- 2007 SpringerBuzug, Thorsten M.
- 2010 CRCnetBASEKoob, George F.; Kuhn, Cynthia.Advances in animal models of relapse for addiction research / Friedbert Weiss -- Application of chronic extracellular recording method to studies of cocaine self-administration : method and progress / Laura L. Peoples, Alexai V. Kravitz, and Karine Guillem -- Neurochemistry of addiction : monitoring essential neurotransmitters of addiction / Stefan G. Sandberg and Paul A. Garris -- Alcohol craving and relapse prediction : imaging studies / Andreas Heinz ... [et al.] -- Integrating behavioral and molecular approaches in mouse : self-administration studies / Danielle L. Graham and David W. Self -- Neuroeconomics : implications for understanding the neurobiology of addiction / Michael L. Platt ... [et al.].
- 2007Iverson, Cheryl.Types of articles -- Manuscript preparation -- References -- Visual presentation of data -- Ethical and legal considerations -- Editorial assessment and processing -- Grammar -- Punctuation -- Plurals -- Capitalization -- Correct and preferred usage -- Non-English words, phrases, and accent marks -- Medical indexes -- Abbreviations -- Nomenclature -- Eponyms -- Greek letters -- Units of measure -- Numbers and percentages -- Study design and statistics -- Mathematical composition -- Typography -- Manuscript editing and proofreading -- Glossary of publishing terms -- Resources.
- 2009 SpringerGross, David R.General principles of animal selection and normal physiological values -- Preanesthesia, anesthesia, chemical restraint, and the recognition and treatment of pain and distress -- Normal cardiac function parameters -- Measuring cardiac function -- Measuring vascular function and ventricular/arterial coupling dynamics -- Isolated heart preparations, problems, and pitfalls -- Cardiovascular effects of anesthetics, sedatives, postoperative analgesic agents, and other pharmaceuticals -- Naturally occurring and iatrogenic animal models of valvular, infectious, and arrhythmic cardiovascular disease -- Iatrogenic models of ischemic heart disease -- Iatrogenic, transgenic, and naturally occurring models of cardiomyopathy and heart failure -- Iatrogenic, congenic, and transgenic models of hypertension -- Naturally occurring, iatrogenic and transgenic models of atherosclerotic disease -- Animal models for the study of neurohumeral and central neural control of the cardiovascular system -- Other transgenic animal models used in cardiovascular studies
- 1973-1976.Bourre, Anne-Laure; Norman-Taylor, William.
- 2009 ebraryGacek, Adam.The main sequence is comprised of approximately 200 entries dealing with almost all aspects of Arabic manuscript studies (codicology and paleography); includes appendices covering abbreviations, letterforms, såurah-headings, major reference works, and a guide to the description of manuscripts, as well as charts of major historical periods and dynasties.
- 2008 CRCnetBASEGoldman, Gustavo Henrique; Osmani, Stephen A.
- Basics of qualitative research : techniques and procedures for developing grounded theory. Fourth edition [4th ed.].2015Corbin, Juliet M.; Strauss, Anselm L.Inspiration and background -- Theoretical foundations -- Practical considerations for getting started -- Prelude to analysis -- Strategies for qualitative data analysis -- Memos and diagrams -- Theoretical sampling -- Context -- Process -- Techniques for achieving theoretical integration -- The use of computer programs in qualitative data analysis -- Open coding: identifying concepts -- Developing concepts in terms of their properties and dimensions -- Analyzing data for context -- Bringing process into the analysis -- Integrating categories -- Writing theses, monographs, and dissertations, and giving talks -- About your research -- Criteria for evaluation -- Student questions and answers.
- 2008 SAGECorbin, Juliet M.; Strauss, Anselm L.Introduction -- Practical considerations -- Prelude to analysis -- Strategies for qualitative data analysis -- Introduction to context, process and theoretical integration -- Memos and diagrams -- Theoretical sampling -- Analyzing data for concepts -- Elaborating the analysis -- Analyzing data for context -- Bringing process into the analysis -- Integrating categories -- Writing theses, monographs, and giving talks -- Criterion for evaluation -- Student questions and answers.
- 2011 CRCnetBASEBerry, Scott M.; Carlin, Bradley P.; Lee, J. Jack; Müller, Peter.Chapter 1. Statistical approaches for clinical trials -- Chapter 2. Basics of Bayesian inference -- Chapter 3. Phase I studies -- Chapter 4. Phase II studies -- Chapter 5. Phase III studies -- Chapter 6. Special topics.
- 2009 CRCnetBASEBroemeling, Lyle D.Chapter 1. Introduction to Agreement -- Chapter 2. Bayesian Methods of Agreement for Two Raters -- Chapter 3. More than Two Raters -- Chapter 4. Agreement and Correlated Observations -- Chapter 5. Modeling Patterns of Agreement -- Chapter 6. Agreement with Quantitative Scores -- Chapter 7. Sample Sizes for Agreement Studies.
- 2008Kirsch, Gesa; Rohan, Liz.Introduction: The role of serendipity, family connections, and cultural memory in historical research / Gesa E. Kirsch and Liz Rohan -- The accidental archivist : embracing chance and confusion in historical scholarship / David Gold -- Being on location : serendipity, place, and archival research / Gesa E. Kirsch -- Getting to know them : concerning research into four early women writers / Christine Mason Sutherland -- Making connections / Alicia Nitecki -- Traces of the familiar : family archives as primary source material / Wendy B. Sharer -- The biography of a graveyard / Ronald R. Stockton -- In a treeless landscape : a research narrative / Kathleen Wider -- My grandfather's trunk / Barry Rohan -- Colonial memory, colonial research : a preamble to a case study / Victor Villanueva -- Unbundling : archival research and Japanese American communal memory of U.S. Justice Department internment, 1941-45 / Gail Y. Okawa -- Mississippi on my mind / W. Ralph Eubanks -- Dreaming Charles Eastman : cultural memory, autobiography, and geography in indigenous rhetorical histories / Malea Powell -- Cultural memory and the lesbian archive / Kate Davy -- "I see dead people" : archive, crypt, and an argument for the researcher's sixth sense / Elizabeth (Betsy) Birmingham -- Stitching and writing a life / Liz Rohan -- When two stories collide, they catch fire / Anca Vlasopolos -- Stumbling in the archives : a tale of two novices / Lisa Mastrangelo and Barbara L'Eplattenier.
- 2010 SpringerCasagrande, John T.; Davuluri, Ramana V.; Ochs, Michael F.
- 2005 NAP
- 2007 SpringerLeong, Stanley P. L.Historical perspective and evolving concerns for human research / Bernard Lo and Nesrin Garan -- Cancer trials and the Institutional Review Board (IRB) / Scott Kurtzman and Zita Lazzarini -- NCI's cancer therapy evaluation program: a commitment to treatment trials / Jeffrey S. Abrams, Anthony Murgo and Michaele C. Christian -- Practical guide for cancer clinical investigators / Steven Hirschfeld -- The role of cooperative groups in cancer clinical trials / Ann M. Mauer, Elizabeth S. Rich and Richard L. Schilsky -- The advocate role in clinical study development and partnering with patient advocates in your local institution / Barbara Parker -- The National Breast Cancer Coalition: setting the standard for advocate collaboration in clinical trials / Fran Visco -- The role of the principal investigator in cancer clinical trials / Stanley P.L. Leong -- The audit process and how to ensure a successful audit / Y. Nancy You, Lisa Jacobs, Elizabeth Martinez and David M. Ota -- The privacy rule (HIPAA) as it relates to clinical research / John M. Harrelson and John M. Falletta -- The Commission on Cancer, American College of Surgeons' response to HIPAA / E. Greer Gay -- Ethical and legal issues in the conduct of cancer clinical trials / Gerianne J. Sands and Peggy A. Means -- The role of the Office of Research Integrity in cancer clinical trials / Peter Abbrecht, Nancy Davidian, Samuel Merrill and Alan R. Price -- Strategies for the administration of a clinical trial infrastructure: lessons from a comprehensive cancer center / Leonard A. Zwelling and Carleen A Brunelli -- The clinical research process: building a system in harmony with its users / Greg Koski -- Cancer research and clinical trial in action: an important exercise before you embark on your study / Stanley P.L. Leong, Larry Carbone and Scott Kurtzman.
- 2006 NLM
- 2007 NCBI BookshelfPatrias, Karen; Wendling, Daniel L.
- 2009 ScienceDirect2009 ClinicalKeyRobertson, David; Williams, Gordon H.
- 2002 CRCnetBASECato, Allen E.; Cato, Allen; Sutton, Lynda.
- 2006 OvidGuyatt, Gordon H.; Haynes, R. Brian; Sackett, David L.; Tugwell, Peter.Forming research questions -- Conducting systematic reviews -- Finding information about the burden of disease -- An introduction to performing therapeutic trials -- The tactics of performing therapeutic trials -- The principles behind the tactics of performing therapeutic trials -- Testing quality improvement interventions -- Evaluating diagnostic tests -- Determining prognosis and creating clinical decision rules -- Assessing claims of causation -- Generating outcome measurements, especially for quality of life -- Becoming a successful clinician-investigator -- Preparing a research protocol to improve its chances for success -- Online data collection -- Analyzing data -- Preparing reports for publication and responding to reviewers' comments -- Dealing with the media.Also available: Print – 2006
- 2015 SpringerBrock-Utne, J. G.This book provides insights into how to be a productive clinical researcher via real-life case examples of successful clinical research -- and also clinical research gone awry. Through these examples of success and failure, the book develops a blueprint for building a career in clinical research. Future medical practice depends on the quality of the clinical trials to which drugs, devices, and treatment procedures are subjected today. However, clinical trials are not easy to do, and many physicians and health care providers who attempt clinical research struggle in this endeavor, primarily because of lack of instruction. Clinical Research aims to fill the gap between training and research through case studies of a long-time clinical researcher's rich and varied experiences.
- 2002 CRCnetBASERosenbaum, Deborah; Dresser, Michelle.
- 2009 Thieme BookBhandari, Mohit; Joensson, Anders.Why we need clinical research -- Historical perspectives of clinical research -- Evidence-based surgery defined -- Myths and misconceptions about evidence-based medicine -- Becoming an evidence-based surgeon -- Principles of clinical research -- Various research design classifications -- Hierarchy of research studies: from case series to meta-analyses -- Randomized and nonrandomized studies -- Understanding research study design -- Clinical case series -- Case-control study -- Prospective cohort study -- Randomized trial -- Meta-analysis -- Economic analysis -- Diagnostic study -- Reliability study -- Understanding outcomes measurement -- Classification of outcomes -- What makes an outcome measure useful -- Common generic outcome scales for surgeons -- Common disease-specific outcome scales for surgeons -- Understanding treatment effects -- Common ways to present treatment effects -- Confidence interval defined -- P value defined -- Errors in hypothesis testing -- Clinical versus statistical significance -- Practice of clinical research -- Planning a research study -- Requirements of a clinical research proposal -- Identification of a good research question -- How to conduct a comprehensive literature search -- Guide to planning a randomized trial -- Guide to planning a nonrandomized study -- Study sample size -- How to budget for a research study -- Research ethics, review boards, and consent forms -- Regulatory issues in the evaluation of a new device or drug -- Strategies in research funding -- Conducting a research study -- Roles of the research team -- Role of a central methods center -- Role of a data monitoring committee -- Need for separate adjudication of outcomes -- Data management -- Study case report forms -- Study manual of operations -- Review of basic statistical principles -- Statistical means and proportions -- Regression analysis -- Analysis of variance -- Correlation defined.
- 2012 SpringerAndrews, James E.; Richesson, Rachel L."This book provides foundational coverage of key areas, concepts, constructs, and approaches of medical informatics as it applies to clinical research activities, in both current settings and in light of emerging policies. The field of clinical research is fully characterized (in terms of study design and overarching business processes), and there is emphasis on information management aspects and informatics implications (including needed activities) within various clinical research environments. The purpose of the book is to provide an overview of clinical research (types), activities, and areas where informatics and IT could fit into various activities and business practices. This book introduces and applies informatics concepts only as they have particular relevance to clinical research settings"--Provided by publisher.
- 2013 ebraryCavalieri, R. Jennifer; Rupp, Mark E.Introduction to research -- Site administration -- Managing financial processes -- Managing regulatory activities and documents -- Managing clinical trial activities -- Managing data and research records -- Conclusions and final remarks.
- 2006 SpringerPenson, David F.; Wei, John.Planning the research / Eugene Blackstone -- Ethical issues in clinical research / David F. Penson -- Budget development and staffing / Judith Fine and Peter C. Albertsen -- Non randomized interventional study designs (quasi-experimental designs) / David Axelrod, Rodney Hayward -- Randomized clinical trials of surgical procedures / Michael P. Porter -- Use of observational databases (registries) in research / Deborah P. Lubeck -- Risk adjustment / William G. Henderson and Shukri F. Khuri -- Basic statistical methods / David Etzioni, Nadia Howlader, and Ruth Etzioni -- Survival analyses / Rodney L. Dunn and John T. Wei -- Assessing the performance and validity of diagnostic tests and screening programs / David C. Miller, Rodney L. Dunn, and John T. Wei -- Secondary data analyses / Andrew Rosenberg, MaryLou VH Greenfield, and Justin B. Dimick -- Traditional outcome measures / Aruna V. Sarma, and Julie C. McLaughlin -- Health-related quality of life / Mark Litwin -- Measuring patient satisfaction / Arvin Koruthu George and Martin G. Sanda -- Quality of care / Jessica B. O'Connell and Clifford Y. Ko -- Cost-effectiveness analyses / Lynn Stothers -- Qualitative research / Donna L. Berry, Sally L. Maliski, and William J. Ellis -- Systematic reviews and meta-analyses / Timothy J. Wilt and Howard A. Fink.
- 2011 CRCnetBASEPeace, Karl E.; Chen, Ding-Geng."Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide a valid inference about the objective of the trial. Drawing from the authors courses on the subject as well as the first authors more than 30 years working in the pharmaceutical industry, Clinical trial methodology emphasizes the importance of statistical thinking in clinical research and presents the methodology as a key component of clinical research. From ethical issues and sample size considerations to adaptive design procedures and statistical analysis, the book first covers the methodology that spans every clinical trial regardless of the area of application. Crucial to the generic drug industry, bioequivalence clinical trials are then discussed. The authors describe a parallel bioequivalence clinical trial of six formulations incorporating group sequential procedures that permit sample size re-estimation. The final chapters incorporate real-world case studies of clinical trials from the authors own experiences. These examples include a landmark Phase III clinical trial involving the treatment of duodenal ulcers and Phase III clinical trials that contributed to the first drug approved for the treatment of Alzheimers disease. Aided by the U.S. FDA, the U.S. National Institutes of Health, the pharmaceutical industry, and academia, the area of clinical trial methodology has evolved over the last six decades into a scientific discipline. This guide explores the processes essential for developing and conducting a quality clinical trial protocol and providing quality data collection, biostatistical analyses, and a clinical study report, all while maintaining the highest standards of ethics and excellence"--Provided by publisher.
- 2006 SpringerFoote, MaryAnn.
- 2011 SpringerKimko, Hui C.; Peck, Carl C.This edition includes both updates and new uses and issues concerning CTS, along with case studies of how clinical trial simulations are being applied in various therapeutic and application areas. Importantly, the book expands on the utility of CTS for informing decisions during drug development and regulatory review. Each chapter author was selected on the basis of demonstrated expertise in state-of-the-art application of CTS. The target audience for this volume includes researchers and scientists who wish to consider use of simulations in the design, analysis, or regulatory review and guidance of clinical trials. This book does not embrace all aspects of trial design, nor is it intended as a complete recipe for using computers to design trials. Rather, it is an information source that enables the reader to gain understanding of essential background and knowledge for practical applications of simulation for clinical trial design and analysis. It is assumed that the reader has a working understanding of pharmacokinetics and pharmacodynamics, modeling, pharmacometric analyses, and/or the drug development and regulatory processes.
- Clinical trials : study design, endpoints and biomarkers, drug safety, FDA and ICH guidelines. 1st ed.2012 ScienceDirect2012 ClinicalKeyBrody, Tom.The origins of drugs -- Introduction to regulated clinical trials -- Run in period -- Inclusion/exclusion criteria, stratification, and subgroups : part I -- Inclusion and stratification criteria : part II -- Randomization, allocation, and blinding -- Placebo arm as part of clinical study design -- Intent to treat analysis vs. per protocol analysis -- Biostatistics -- Introduction to endpoints for clinical trials in pharmacology -- Endpoints in clinical trials on solid tumors : objective response -- Oncology endpoints : overall survival and progression free survival -- Oncology endpoints : time to progression -- Oncology endpoint : disease free survival -- Oncology endpoint : time to distant metastasis -- Neoadjuvant therapy versus adjuvant therapy -- Hematological cancers -- Biomarkers and personalized medicine -- Endpoints in immune diseases -- Endpoints in clinical trials on infections -- Health related quality of life -- Health related quality of life instruments for immune disorders -- Health related quality of life instruments and infections -- Drug safety -- Mechanism of action : part I -- Mechanism of action, part II : cancer -- Mechanism of action, part III : immune disorders -- Mechanisms of action, part IV : infections -- Consent forms -- Package inserts -- Regulatory approval -- Patents.
- 2006 CRCnetBASERobinson, Martin; Cook, Simon.
- Green, Sally; Higgins, Julian P. T."The Cochrane Handbook for Systematic Reviews of Interventions (the Handbook) provides guidance to authors for the preparation of Cochrane Intervention reviews (including Cochrane Overviews of reviews)." "The Handbook is updated regularly to reflect advances in systematic review methodology and in response to feedback from users. Please refer to the web site for the most recent version, for interim updates to the guidance and for details of previous versions of the Handbook."
- 2010 ProQuest SafariWalker, Glenn A.; Shostak, Jack.Introduction & basics -- Topics in hypothesis testing -- The data set TRIAL -- The one-sample t-test -- The two-sample t-test -- One-way ANOVA -- Two-way ANOVA -- Repeated measures analysis -- The crossover design -- Linear regression -- Analysis of covariance -- The Wilcoxon signed-rank test -- The Wilcoxon rank-sum test -- The Kruskal-Wallis test -- The binomial test -- The Chi-square test -- Fisher's exact test -- McNemar's test -- The Cochran-Mantel-Haenszel test -- Logistic regression -- The log-rank test -- The Cox proportional hazards model -- Exercises.Also available: Print – 2010
- 2010Dawson, Maureen M.; Dawson, Brian A.; Overfield, J.Communication skills in science -- Using scientific literature -- Essay writing -- Writing practical reports -- The project report -- Scientific posters -- Oral presentations -- Preparing a curriculum vitae and job application.
- 2011 ProQuest SafariThompson, Waddy.The Practice of Grant Writing -- The ABCs of Grants -- A Foundation Primer -- A Corporation Primer -- A Government Primer -- An Individual Donor Primer -- You Can Find It Online -- You Can Find It Offline -- Narrowing Your Prospects -- Sow Before You Reap -- Testing the Waters -- Planning for Success, Now and Tomorrow -- The Parts of a Grant Proposal -- Selling Your Project -- Dollars and Cents -- The Cover Letter and Executive Summary -- Repute and Tribute -- Putting It All Together -- Other Types of Applications -- Waiting for and Receiving the Verdict -- Reporting on Success -- Advice for Individual Grant Seekers -- Working as a Freelance Grant Writer -- The Business Side of Freelancing.
- 2002 CRCnetBASEGould, Jay E.; Gould, Jay E.
- 2011 CRCnetBASEChow, Shein-Chung."Preface In pharmaceutical/clinical development of a test drug or treatment, relevant clinical data are usually collected from subjects with the diseases under study in order to evaluate safety and efficacy of the test drug or treatment under investigation. To provide accurate and reliable assessment, well-controlled clinical trials under valid study design are necessarily conducted. Clinical trial process is a lengthy and costly process, which is necessary to ensure a fair and reliable assessment of the test treatment under investigation. Clinical trial process consists of protocol development, trial conduct, data collection, statistical analysis/interpretation, and reporting. In practice, controversial issues evitably occur regardless the compliance of good statistical practice (GSP) and good clinical practice (GCP). Controversial issues in clinical trials are referred to as debatable issues that are commonly encountered during the conduct of clinical trials. In practice, controversial issues could be raised from, but are not limited to, (1) compromises between theoretical and real/common practices, (2) miscommunication and/or misunderstanding in perception/interpretation among regulatory agencies, clinical scientists, and biostatisticians, and (3) disagreement, inconsistency, miscommunication/misunderstanding, and errors in clinical practice"--Provided by publisher.
- 2013 NAPLeshner, Alan I.; Liverman, Catharyn T.; Schultz, Andrea M.; Terry, Sharon.This report provides the IOM committee's findings and recommendations regarding the progress and potential of NIH's CTSA Program. The report covers the breadth of the statement of task and highlights opportunities to bolster the program and ensure its continued success and sustainability in supporting clinical and translational researchers and serving the needs of the communities CTSAs are linked to and in which they reside. Chapter 2 discusses the ecosystem in which NCATS and the CTSA Program operate and provides the committee's vision for the next phase of the CTSA Program. Chapter 3 emphasizes the need for strong and active leadership by NCATS in establishing a clear vision and mission for the program along with measurable goals; supporting individual CTSAs; partnering and collaborating within the NIH and with external partners; and evaluating and communicating the program's value. Chapter 4 highlights specific opportunities and priorities in the areas of training and education, community engagement, and research related to child health. On the basis of discussions, conclusions, and recommendations outlined in the preceding chapters, in Chapter 5 the report concludes with next steps and potential future directions.
- 2009 CRCnetBASEHerson, Jay.Introduction -- Organization of a safety monitoring program for a confirmatory trial -- Meetings -- Clinical issues -- Statistical issues -- Bias and pitfalls -- Data monitoring committee decisions -- Emerging issues.
- 2006 SpringerDeMets, David L.; Friedman, Lawrence M.; Furberg, Curt.Also available: Print – 2006
- 2002 NAPLeibowitz, Arleen; Pollack, Earl S.
- 2009 CRCnetBASEPeace, Karl E.Overview of time-to-event endpoint methodology / Karl E. Peace -- Design (and monitoring) of clinical trials with time-to-event endpoints / Michael W. Sill and Larry Rubinstein -- Overview of time-to-event parametric methods / Karl E. Peace and Kao-Tai Tsai -- Overview of semiparametric inferential methods for time-to-event endpoints / Jianween Cai and Donglin Zeng -- Overview of inferential methods for categorical time-to-event data / Eric V. Slud -- Overview of Bayesian inferential methods including time-to-event endpoints / Laura H. Gunn -- An efficient alternative to the Cox model for small time-to-event trials / Devan V. Mehrotra and Arthur J. Roth -- Estimation and testing for change in hazard for time-to-event endpoints / Rafia Bhore and Mohammad Huque -- Overview of descriptive and graphical methods for time-to-event data / Michael O'Connell and Bob Treder -- Design and analysis of analgesic trials / Akiko Okamoto, Julia Wang, and Surya Mohanty -- Design and analysis of analgesic trials with paired time-to-event endpoints / Zhu Wang and Hon Keung Tony Ng -- Time-to-event endpoint methods in antibiotic trials / Karl E. Peace -- Design and analysis of cardiovascular prevention trials / Michelle McNabb and Andreas Sashegyi -- Design and analysis of antiviral trials / Anthony C. Segreti and Lynn P. Dix -- Cure rate models with applications to melanoma and prostate cancer data / Ming-Hui Chen and Sungduk Kim -- Parametric likelihoods for multiple nonfatal competing risks and death, with application to cancer data / Peter F. Thall and Xuemei Wang -- Design, summarization, analysis, and interpretation of cancer prevention trials / Matthew C. Somerville, Jennifer B. Shannon, and Timothy H. Wilson -- LASSO method in variable selection for right-censored time-to-event data with application to astrocytoma brain tumor and chronic myelogonous leukemia / Lili Yu and Dennis Pearl -- Selecting optimal treatments based on predictive factors / Eric C. Polley and Mark J. van der Laan -- Application of time-to-event methods in the assessment of safety in clinical trials / Kelly L. Moore and Mark J. van der Laan -- Design and analysis of chronic carcinogenicity studies of pharmaceuticals in rodents / Mohammad Atiar Rahman and Karl K. Lin -- Design and analysis of time-to-tumor response in animal studies : a Bayesian perspective / Steve Thomson and Karl K. Lin.
- 2010 CRCnetBASEFairclough, Diane Lynn.Using SAS, SPSS, and R, this book addresses design and analysis aspects in enough detail so that readers can apply statistical methods to their own longitudinal studies. This edition includes a new chapter on testing models that involve moderation and mediation, a new chapter on QALYs and QTWiST specific to clinical trials, and recent methodological developments for the analysis of trials with missing data. It also presents revised discussions of multiple comparisons procedures that focus on the integration of HRQoL outcomes with other study outcomes using gatekeeper strategies.
- 2011Creswell, John W.; Plano Clark, Vicki L."Combining the latest thinking about mixed methods research designs with practical, step-by-step guidance, the Second Edition of Designing and Conducting Mixed Methods Research now covers six major mixed methods designs. Authors John W. Creswell and Vicki L. Plano Clark walk readers through the entire research process, from formulating questions to designing, collecting data, and interpreting results and include updated examples from published mixed methods studies drawn from the social, behavioral, health, and education disciplines."--pub. desc.
- 2007 OvidHulley, Stephen B.Designing a randomized blinded trial / Steven R. Cummings, Deborah Grady, and Stephen B. Hulley -- Alternative trial designs and implementation issues / Deborah Grady, Steven R. Cummings, and Stephen B. Hulley -- Designing studies of medical tests / Thomas B. Newman ... [et al.] -- Utilizing existing databases / Deborah Grady and Norman Hearst -- Addressing ethical issues / Bernard Lo -- Designing questionnaires and interviews / Steven R. Cummings and Stephen B. Hulley -- Data management / Michael A. Kohn -- Implementing the study and quality control / Deborah Grady and Stephen B. Hulley -- Community and international studies / Norman Hearst and Thomas E. Novotny -- Writing and funding a research proposal / Steven R. Cummings and Stephen B. Hulley. Getting started: the anatomy and physiology of clinical research / Stephen B. Hulley, Thomas B. Newman, and Steven R. Cummings -- Conceiving the research question / Steven R. Cummings, Warren S. Browner, and Stephen B. Hulley -- Choosing the study subjects: specification, sampling, and recruitment / Stephen B. Hulley, Thomas B. Newman, and Steven R. Cummings -- Planning the measurements: precision and accuracy / Stephen B. Hulley, Jeffrey N. Martin and Steven R. Cummings -- Getting ready to estimate sample size: hypotheses and underlying principles / Warren S. Browner, Thomas B. Newman, and Stephen B. Hulley -- Estimating sample size and power: applications and examples / Warren S. Browner, Thomas B. Newman, and Stephen B. Hulley -- Designing a cohort study / Steven R. Cummings, Thomas B. Newman, and Stephen B. Hulley -- Designing cross-sectional and case-control studies / Thomas B. Newman ... [et al.] -- Enhancing causal inference in observational studies / Thomas B. Newman, Warren S. Browner, and Stephen B. Hulley --
- 2012 SpringerHarrington, David P.
- Developing a national registry of pharmacologic and biologic clinical trials : workshop report (2006)2006 NAP
- 1999 WileyDay, Simon.
- v. 1-<2>, 1981-<83>Friedberg, Errol C.; Hanawalt, Philip C.
- 2006 Springer ProtocolsBrandsma, Janet L.; Saltzman, W. Mark; Shen, Hong.DNA vaccine design / Janet L. Brandsma -- Design of plasmid DNA constructs for vaccines / Donna L. Montgomery and Kristala Jones Prather -- Vaccination with messenger RNA / Stave Pascolo -- A stress protein-facilitated antigen expression system for plasmid DNA vaccines / Petra Riedl ... [et al.] -- In vitro assay of immunostimulatory activities of plasmid vectors / Weiwn Jiang, Charles F. Reich, and David S. Pisetsky -- Delivery of DNA vaccines using electroporation / Shawn Babiuk, Sylvia van Drunen Littel-van den Hurk, and Lorne A. Babiuk -- Needle-free injection of DNA vaccines: a brief overview and methodology / Kanakatte Raviprakash and Kevin R. Porter -- Needle-free delivery of veterinary DNA vaccines / Sylvia van Drunen Littel-van den Hurk, Shawn Babiuk, and Lorne A. Babiuk -- Surface-modified biodegradable microspheres for DNA vaccine delivery / Mark E. Keegan and W. Mark Saltzman -- A dendrimer-like DNA-based vector for DNA delivery: a viral and nonviral hybrid approach / Dan Luo ... [et al.] -- Identification of compartments involved in mammalian subcellular trafficking pathways by indirect immunofluorescence / Anne Doody and David Putnam -- Adjuvant properties of CpG oligonucleotides in primates / Daniela Verthelyi -- Complexes of DNA vaccines with cationic, antigenic peptides are potent, polyvalent CD8+ T-cell stimulating immunogens / Petra Riedl, Jörg Reimann, and Reinhold Schirmbeck -- Prime-boost strategies in DNA vaccines / C. Jane Dale ... [et al.] -- Modifying professional antigen-presenting cells to enhance DNA vaccine potency / Chien-Fu Hung, Mu Yang, and T.C. Wu -- Replicase-based DNA vaccines for allergy treatment / Sandra Scheiblhofer ... [et al.] -- Immunological responses of neonates and infants to DNA vaccines / Martha Sedegah and Stepen L. Hoffman -- DNA vaccines for allergy treatment / Richard Weiss, Sandra Sheiblhofer, and Josef Thalhamer -- Protection from autoimmunity by DNA vaccination against T-cell receptor / Thorsten Buch and Ari Waisman -- The use of bone marrow-chimeric mice in elucidating immune mechanisms / Akiko Iwasaki -- A simple method for the production of plasmid DNA in bioreactors / Kristin Listner, Laura Kizer Bentley, and Michel Chartrain -- Practical methods for supercoiled pDNA production / John Ballantyne -- Production of plasmid DNA in industrial quantities according to cGMP guidelines / Joachim Schorr ... [et al.] -- Large-scale, nonchromatographic purification of plasmid DNA / Jason C. Murphy, Michael A. Winters, and Sangeetha L. Sagar -- Assuring the quality, safety, and efficacy of DNA vaccines / James S. Robertson and Elwyn Griffiths.
- 2008 SpringerLiamputtong, Pranee.
- 2011 CRCnetBASECheung, Ying Kuen.Part I. Fundamentals -- Chapter 1. Introduction -- Chapter 2. Dose Finding in Clinical Trials -- Chapter 3. The Continual Reassessment Method -- Chapter 4. One-Parameter Dose-Toxicity Models -- Chapter 5. Theoretical Properties -- Chapter 6. Empirical Properties -- Part II. Design Calibration -- Chapter 7. Specifications of a CRM Design -- Chapter 8. Initial Guesses of Toxicity Probabilities -- Chapter 9. Least Informative Normal Prior -- Chapter 10. Initial Design -- Part III. CRM and Beyond -- Chapter 11. The Time-to-Event CRM -- Chapter 12. CRM with Multiparameter Models -- Chapter 13. When the CRM Fails -- Chapter 14. Stochastic Approximation.
- 2010 KargerKoletzko, B.; Koletzko, Sibylle; Rümmele, Frank.Innovations in infant milk feeding : from the past to the future / Koletzko, B. -- Novel insights into human lactation as a driver of infant formula development / Lønnerdal, B. -- The clinical challenge of preventing and treating malnutrition / Cooper, P.A. -- Progress of enteral feeding practice over time : moving from energy supply to patient-and disease-adapted formulationse / Koletzko, S. -- Molecular mechanisms of pediatric nutrition / Rümmele, F. -- Epidemiological research drives a paradigm shift in complementary feeding : the celiac disease story and lessons learnt / Nordyke, K. ... [et al.] -- Technological progress as a driver of innovation in infant foods / Ferruzzi, M.G.; Neilson, A.P. -- Health economic perspectives of pediatric malnutrition : determinants of innovative progress / Spieldenner, J. -- Economic perspectives on pediatric obesity : impact on health care expenditures and cost-effectiveness of preventive interventions / John, J. -- Sustainable clinical research, health economic aspects, and marketing : drivers of product innovation / Haschke, F.; Klassen-Wigger, P. -- Evaluation of dietetic product innovations : the relative role of preclinical and clinical studies / Makrides, M.; Gibson, R.A. -- Regulatory environment and claims : limits and opportunities / Martin, A. -- The role of consumers / Raats, M.M. -- Bioethics and innovation in pediatric nutrition research / Solomons, N.W. -- The role of pediatricians as innovators in pediatric nutrition / Greer, F.R. -- Promoting innovation in pediatric nutrition / Bier, D.M.
- 2002 NAPAmado, Nicole L.; Rice, Dorothy P.; Wunderlich, Gooloo S.
- Early nutrition and its later consequences : new opportunities : perinatal programming of adult health - EC supported research2005 SpringerAshwell, Margaret; Åkerblom, Hans K.; Dodds, Peter; Koletzko, B.What is the EU infant nutrition cluster? -- Early nutrition and its later consequences: new opportunities -- The developmental origins of adult health and well-being -- Long term effects of breastfeeding on the infant and mother -- Experimental evidence for long-term programming effects of early diet -- Candidate genes for obesity--how might they interact with environment and diet? -- Rate of growth in early life: a predictor of later health? -- Protective effect of breast-feeding against obesity in childhood-- Discussion forum: from innovation to implementation -- Challenges and opportunities in pan-European collaboration for researchers from Central and Eastern Europe -- Best practice in communicating the results of European research to the public -- Longterm effects of pre- and postnatal exposure to low and high dietary protein levels / Cornelia C. Metges -- Protein intake in the first year of life: a risk factor for later obesity? -- The role of long-chain poly-unsaturated fatty acids (LCPUFA) in growth and development -- Experimental models for studying perinatal lipid metabolism -- Effect of N-3 polyunsaturated fatty acid supplementation in pregnancy: the Nuheal trial -- Young researchers' workshop -- Consumer needs regarding dietetic products for pregnant and lactating women and for baby foods -- Focus group: breakfast meeting: SMES and their co-operation with academia -- Ethical issues in perinatal nutrition research -- Early programming of diabetes risk--an introduction -- Early nutrition and later diabetes risk -- Is type 1 diabetes a disease of the gut immune system triggered by cow's milk insulin? -- Gluten-free diet in subjects at risk for type 1 diabetes: a tool for delaying progression to clinical disease? -- Insulin like growth factor regulation of body mass in breastfed and milk formula fed infants -- Inverse association between trans isomeric and long-chain polyunsaturated fatty acids in erythrocyte membrane lipids in pregnant women -- Comparison of essential fatty acid status among German, Hungarian and Spanish women at mid-gestation -- Trans isomeric fatty acids as confounding variables in studies on perinatal LC-PUFA supply -- An eight years prospective study of iron deficiency anaemia in infancy -- New insights in the potential mechanism of action of nucleotides to modulate immunity -- Thriving of malnourished breastfed infants after additional formula milk feeding -- Role of mammary gland lipoprotein lipase in the availablilty of polyunsaturated fatty acids for milk synthesis -- Is the crying behaviour in infants up to the age of 3 months influenced by the type of early nutrition? -- Dietary gangliosides: beneficial effects for the neonate and potential mechanism of action -- Leptin in breast-fed and formula-fed infants -- Dietary fatty acids during pregnancy determines maternal fatty acid profile during late pregnancy and their availability to the fetus even during fasting condtions -- Effects of oil-supplemented diets on liver expression of PPAR alpha-related genes in pregnant rats -- Effect of a new infant formula enriched with prebiotics, probiotics, nucleotides and LC-PuFA on recovery after infection -- Does habitual protein intake in early childhood influence age and body mass index at adiposity rebound? -- Dietary compliance in diabetes prevention project in Finland -- Changes of plasma fatty acid profile and antioxidant vitamins during normal pregnancy -- Optimal design for the recruitment of participants as a factor for the effective implementation of a clinical trial -- The effect of ponderal index on plasma concentration of insulin-like growth factor-1 (IGF-1) in neonatal pigs -- Effects of prenatal exposure to low and high dietary protein levels on maternal and fetal amino acid metabolism in rats -- Cow's milk introduction in Spanish infants -- Longer term effects of early cholesterol intake on cholesterol biosynthesis and plasma lipids: a randomized clinical trial -- Patterns of growth and energy utilization of the diet after a period of dietary restriction during the weaning period -- Infant formula feeding pattern and weaning introduction in Spanish infants -- Visual evoked potentials in infants after dietary supply of docosahexaenoic acid and 5-methyltetrahydrofolate during pregnancy -- Electronic data capture and use of internet technologies in a double-blind randomised intervention trial -- Breastfeeding and baby friendly hospital initiative in Slovenia -- Nutritional status in young adults with screen-detected silent/sub-clinical coeliac disease -- Liporotein lipase (LPL) MRNA expression in placentas from normal and IUGR (intrauterine growth restricted) pregnancies by real-time PCR -- Maternal fasting effect on neonatal health -- The quality of schoolchildren's nutrition in Serbia -- Tendency towards obesity in Sydney school children -- Monitoring and supervising a dietary intervention trial using modern data processing system -- Analysis of drop-outs in a longitudinal study -- Recruitment strategies of the Spanish group in the "EU childhood obesity: programming by infant nutrition" -- Diet and nutritional risk factors in schoolchildren -- Influence of two forms of caseinophosphopeptide on iron bio availability -- Model of childhood obesity primary prevention programme -- Problems related to recruitment of participants for the triger project -- Vitamin D status at birth in Brussels--preliminary results -- Obesity among young adolescent Kuwaitis -- Dynamic changes in adiposity from fetal to postnatal life are involved in the adult metabolic syndrome associated with reduced fetal growth -- Excess fetal adiposity is associated with programming of placental lipid genes -- Appetite control in breastfed and formula fed infants -- What are the Danone Institutes.Also available: Print – 2005
- 2009 SpringerDepaepe, Marc; Smeyers, Paul.
- Élèves de Claude Bernard : les nouvelles disciplines physiologiques en France au tournant du du XXe siècleBarbara, Jean-Gaël; Corvol, Pierre.PrintLane Catalog Record
- 2007Brady, Catherine.A certain sense of self -- Shedding encumbrances -- One of Gall's gals -- Revelations -- Opportunism -- Gold rush -- Entering the fray -- An interlocking system -- Dr. Jekyll or Mr. Hyde? -- Members of a guild -- Citizen scientist -- Political fallout -- "You have to think it's fun" -- Notes -- Bibliography.
- 2001 CRCnetBASEGilbert, Kathleen R.
- 2009 SpringerRibes, Ramón; Duarte, Rafael F.; Iannarelli, Palma.
- 2012 SpringerMiettinen, Olli S.; Karp, I.Epidemiology: Grappling with the Concept -- Epidemiological Knowledge: Examples -- Etiology as a Pragmatic Concern -- Etiology as the Object of Study -- Etiologic Studies' Essentials -- Etiologic Studies' Typology -- Etiologic Studies' Objects Design -- Etiologic Studies' Methods Design -- Etiologic Studies' Intervention Counterparts -- Causal Studies' Acausal Counterparts -- Studies on Screening for a Cancer -- Some Paradigmatic Studies -- From Studies to Knowledge -- Fact-finding in Epidemiological Practice.
- 2013 WileyLangton, Phil.This concise, easy-to-follow text gives an insight into core techniques and practices in biomedical research and how, when and why a technique should be used and presented in the literature. Readers are alerted to common failures and misinterpretations that may evade peer review and are equipped with the judgment necessary to be properly critical of the findings claimed by research articles. --from publisher description
- 2014 SpringerGlasser, Stephen P.In its extensively revised and updated Second Edition, this book provides a solid foundation for readers interested in clinical research. Discussion encompasses genetic, pharmacoepidemiologic and implementation research. All chapters have been updated with new information and many new tables have been added to elucidate key points. The book now offers discussion on how to handle missing data when analyzing results, and coverage of Adaptive Designs and Effectiveness Designs and new sections on Comparative Effectiveness Research and Pragmatic Trials. Chapter 6 includes new material on Phase 0 Trials, expanded coverage of Futility Trials, a discussion of Medical Device approval, Off Label Drug use and the role of the FDA in regulating advertising. Additional new information includes the role of pill color and shape in association with the placebo effect and an examination of issues surrounding minority recruitment. The final chapter offers a new section on manuscript preparation along with a discussion of various guidelines being adopted by journals: CONSORT, STROBE, PRISMA, MOOSE and others; and coverage of Conflicts of Interest, Authorship, Coercive Citation, and Disclosures in Industry-Related Associations. Building on the strengths of its predecessor in its comprehensive approach and authoritative advice, the new edition offers more of what has made this book a popular, trusted resource for students and working researchers alike.
- 2008 SpringerGlasser, Stephen P.I. pt. I. Clinical Research: Definitions, "Anatomy and Physiology," and the Quest for "Universal Truth" / Stephen P. Glasser, p. 3-11 -- Introduction to Clinical Research and Study Designs / Stephen P. Glasser, p. 13-27 -- Clinical Trials / Stephen P. Glasser, p. 29-62 -- Alternative Interventional Study Designs / Stephen P. Glasser, p. 63-71 -- Postmarketing Research / Stephen P. Glasser, Elizabeth Delzell and Maribel Salas, p. 73-91 -- The United States Federal Drug Administration (FDA) and Clinical Research / Stephen P. Glasser, Carol M. Ashton and Nelda P. Wray, p. 73-110 -- The Placebo and Nocebo Effect / Stephen P. Glasser and William Frishman, p. 111-140 -- Recruitment and Retention / Stephen P. Glasser, p. 141-149 -- Data Safety and Monitoring Boards (DSMBs) / Stephen P. Glasser and O. Dale Williams, p. 151-158 -- Meta-Analysis / Stephen P. Glasser and Sue Duval, p. 159-177 -- II. pt. II. -- Research Methods for Genetic Studies / Sadeep Shrestha and Donna K. Arnett, p. 181-199 -- Research Methods for Pharmacoepidemiology Studies / Maribel Salas and Bruno Stricker, p. 201-216 -- Implementation Research: Beyond the Traditional Randomized Controlled Trial / Amanda H. Salanitro, Carlos A. Estrada and Jeroan J. Allison, p. 217-244 -- Research Methodology for Studies of Diagnostic Tests / Stephen P. Glasser, p. 245-257 -- III. pt. III. Statistical Power and Sample Size: Some Fundamentals for Clinician Researchers / J. Michael Oakes, p. 261-278 -- Association, Cause, and Correlation / Stephen P. Glasser and Gary Cutter, p. 279-294 -- Bias, Confounding, and Effect Modification / Stephen P. Glasser , p. 295-302 -- It's All About Uncertainty / Stephen P. Glasser and George Howard, p. 303-316 -- Grant Writing / Donna K. Arnett and Stephen P. Glasser, p. 317-325 -- IV. pt. IV. The Media and Clinical Research / Stephen P. Glasser, p. 329-333 -- Mentoring and Advising / Stephen P. Glasser and Edward W. Hook, p. 335-340 -- Presentation Skills: How to Present Research Results / Stephen P. Glasser, p. 341-349.
- 2007 SpringerFurberg, Bengt; Furberg, Curt.
- 2012 SpringerGutiérrez Diez, Pedro J.; Russo, Irma H.; Russo, Jose.Historical Introduction -- Descriptive Biostatistics -- Inferential Biostatistics (I): Estimating Values of Biomedical Magnitudes -- Inferential Biostatistics (II): Estimating Biomedical Behaviors -- Equations: Formulating Biomedical Laws and Biomedical Magnitudes -- Systems of Equations: The Explanation of Biomedical Phenomena (I). Basic Questions -- Systems of Equations: The Explanation of Biomedical Phenomena (II). Dynamic Interdependencies -- Optimal Control Theory: From Knowledge to Control (I). Basic Concepts -- Optimal Control Theory: From Knowledge to Control (II). Biomedical Applications -- Game Theory.
- 2014 Thieme-ConnectSimpson, A. Hamish R. W.; Augat, Peter.
- Fairchild era : three decades of collaboration and discovery at Stanford University School of Medicine2008
- 2003 CRCnetBASENiazi, Sarfaraz.
- 2011 CRCnetBASEWienke, Andreas.The concept of frailty offers a convenient way to introduce unobserved heterogeneity and associations into models for survival data. In its simplest form, frailty is an unobserved random proportionality factor that modifies the hazard function of an individual or a group of related individuals. Frailty Models in Survival Analysis presents a comprehensive overview of the fundamental approaches in the area of frailty models. The book extensively explores how univariate frailty models can represent unobserved heterogeneity. It also emphasizes correlated frailty models as extensions of univariate and shared frailty models. The author analyzes similarities and differences between frailty and copula models; discusses problems related to frailty models, such as tests for homogeneity; and describes parametric and semiparametric models using both frequentist and Bayesian approaches. He also shows how to apply the models to real data using the statistical packages of R, SAS, and Stata. The appendix provides the technical mathematical results used throughout. Written in nontechnical terms accessible to nonspecialists, this book explains the basic ideas in frailty modeling and statistical techniques, with a focus on real-world data application and interpretation of the results. By applying several models to the same data, it allows for the comparison of their advantages and limitations under varying model assumptions. The book also employs simulations to analyze the finite sample size performance of the models.--From the publisher's website.
- 2009 SpringerKatz, Michael Jay.
- 2007 SpringerBacchieri, Antonella; Della Cioppa, Giovanni.
- 2010 SpringerFriedman, Lawrence M.; DeMets, David L.; Furberg, Curt.Introduction to Clinical Trials -- Ethical Issues -- What Is the Question? -- Study Population -- Basic Study Design -- The Randomization Process -- Blindness -- Sample Size -- Baseline Assessment -- Recruitment of Study Participants -- Data Collection and Quality Control -- Assessing and Reporting Adverse Events -- Assessment of Health-Related Quality of Life -- Participant Adherence -- Survival Analysis -- Monitoring Response Variables -- Issues in Data Analysis -- Closeout -- Reporting and Interpreting of Results -- Multicenter Trials.Also available: Print – 2010
- 2010Cox, Emily Ann; Byers, Thomas; Eisenhardt, Kathleen M.; Katila, Riitta.This dissertation explores the impact of different types of investors on invention and innovation in new firms. While prior work has focused primarily on one type of investor, venture capitalists, and has investigated a few long-term outcomes such as exit events, I compare a variety of investor types and consider more immediate innovation-related goals. Drawing from agency and resource dependence theories, I develop and test hypotheses linking different investor types to invention and innovation in new firms. To do this, I construct a novel longitudinal dataset of 198 U.S.-based minimally invasive surgical device firms between 1986 and 2007. The findings indicate that investor type matters for both invention and innovation. Technology-focused investors promote invention while commercially-focused investors are more beneficial to innovation. I also find that although some investors (VCs) help innovation, other investors (the government's SBIR program) hurt it. This difference can be traced to investors' use of monitoring to tailor resources to the specific needs of new firms. These findings suggest that monitoring can be mutually beneficial to both parties as it allows investors to focus their efforts and new firms to receive needed resources at opportune times. My findings also suggest that new firms should be cautious, as there is a potential dark side to the relationships they form with investors: obtaining resources from some investors may prevent new firms from accomplishing their goals.
- 2009 CRCnetBASEGöhlmann, Hinrich; Talloen, Willem."Gene expression studies merge three disciplines with different historical backgrounds: molecular biology, bioinformatics, and biostatistics. This book tears down the omnipresent language barriers among researchers of these different backgrounds by explaining the entire process of a gene expression study from conception to interpretation. It covers important technical and statistical pitfalls and problems, helping not only to explain concepts outside the domain of researchers, but to provide additional guidance in their field of expertise. The book also describes technical and statistical methods conceptually with illustrative examples, enabling those inexperienced with gene expression studies to grasp the basic principles"--Provided by publisher.
- 2014 Oxford Medicine OnlineMacFarlane, Ian M.; LeRoy, Bonnie; Veach, Patricia McCarthy.Developing research questions -- Finding sources -- Writing a review of literature -- Ethics in research -- Choosing a paradigm -- Designing a quantitative study -- Quantitative data analysis : I've got data, how do I get answers? -- Conducting qualitative genetic counseling research -- Preparing a manuscript for publication -- Guidelines for directing research.
- 2011 Thieme BookBhandari, Mohit; Joensson, Anders.Why should we publish papers? / George M. Kontakis, Peter V. Giannoudis -- Presented but never published : why research papers are not being published / Cheryl Wylie, Sheila Sprague -- What is the quality of the published orthopaedic literature? / Daniel Vena, Sheila Sprague -- Common pitfalls in the reporting of surgical results / Rudolf W. Poolman -- Overview : what to consider before you start writing / Paul Karanicolas -- Ethics in writing : maintaining credibility / Lyndsay Somerville, Dianne Bryant -- Authorship : what you should know / Rad Zdero, Emil H. Schemitsch -- When do you need a statistician? : more than just number crunchers / Jason W. Busse -- The structured abstract / Ole Brink, Lars C. Borris -- Writing an introduction / Emil H. Schemitsch, Rad Zdero -- Writing a methods section / Emil H. Schemitsch, Rad Zdero -- Results : basics of analysis / Paul Karanicolas -- Results : tables, figures, and appendices / Jacquelyn Marsh, Dianne Bryant -- How to frame a discussion / Kyle Jeray, Stephanie Tanner -- Referencing and acknowledgments / Richard Gould, Bradley Petrisor -- Author instructions / George Mathew, Sheila Sprague -- Formatting your paper : title page and more / Scott Wingerter -- Grammar police : the dos and don'ts of writing / Eric Morrison -- How to address reviewer's comments : dos and don'ts / Rad Zdero, Emil H. Schemitsch -- Getting your research accepted at scientific meetings : writing the abstract / George Mathew, Sheila Sprague -- PowerPoint presentations : tips for presenting your work / Tara M. Mastracci -- Poster presentations : preparing an effective research poster / Chad Coles -- Be consistent : present and publish the same results / Boris A. Zelle.
- 2011 ScienceDirectBairu, Menghis; Chin, Richard Y.
- 2006Dornfest, Rael; Bausch, Paul; Calishain, Tara.Web -- Advanced web -- News and blogs -- Extending Google -- Google maps -- Gmail -- Webmastering -- Programming Google.
- 2006 SpringerKogan, Maurice; Hanney, Stephen; Henkel, Mary.
- v.1-4, 2014Charmaz, Kathy; Clarke, Adele.v. 1. History, essential and debates in grounded theory -- v. 2. Grounded theory in disciplines and research -- v. 3. Grounded theory exemplars across disciplines -- v. 4. Situational analysis : essentials and exemplars.
- 2012 SpringerYang, Otto O.Overview: overall goals when writing grant applications -- Organization and use of this guide -- Preparing to write -- Types of NIH grants -- Anatomy of the NIH grant application -- Starting to write: planning the aims and overcoming writer's block -- Organization and writing style -- Figures and tables -- Specific aims -- Research strategy: significance -- Research strategy: innovation -- Research strategy: approach -- Bibliography and references cited -- Use of appendices -- Collaborators and consultants -- Training and career development grants -- Administrative sections and submission process -- Scoring process -- Resubmitting an application -- Non-NIH grants -- Conclusions.
- 2005 NAP
- 2006 SpringerBukoski, William J.; Sloboda, Zili.I: HISTORICAL OVERVIEW: The emerging science of drug abuse prevention / William J. Bukoski -- II: SOCIAL CONTEXTS OF PREVENTION: Effective mass media strategies for drug abuse prevention campaigns / Philip Palmgreen and Lewis Donohew -- Drug abuse prevention curricula in schools / Gilbert J. Botvin and Kenneth W. Griffin -- Dissemination of research-based family intervention for the prevention of substance abuse / Karol L. Kumpfer and Steve Adler -- Peers and the prevention of adolescent drug use -- / E. R. Oetting and R. S. Lynch -- Mobilizing communities to reduce risk for drug abuse: a comparison of two strategies / Michael W. Arthur, Charles D. Ayers, Kelly A. Graham, and J. David Hawkins -- Community-focused drug abuse prevention / Barry M. Kibel and Harold D.Holder -- Drug abuse prevention in the workplace / Royer F. Cook -- Prevention approaches to methadone treatment settings: children of drug abuse treatment clients / Richard F. Catalano, Kevin P. Haggerty, and Randy R. Gainey -- III: PREVENTION AS SOCIAL CONTROL: Drug tests in prevention research / Robert L. DuPont and Keith E. Saylor -- Anti-drug-abuse policies on prevention strategies / Mary Ann Pentz -- IV: THEORETICAL AND EMPIRICAL FOUNDATIONS OF PREVENTION: Forging a relationship between drug abuse epidemiology and drug abuse prevention / Zili Sloboda -- Risk and protective factors of adolescent drug use: implications for prevention programs / Judith S. Brook. David W. Brook, Linda Richter, and Martin Whiteman -- Bridging the gap between substance use prevention theory and practice / Brian R. Flay and John Petraitis -- Preventive intervention targeting precursors / John E. Lochman -- Designing prevention programs: the developmental perspective / Marvin W. Berkowitz and Audrey L. Begun -- V: SPECIAL POPULATIONS: Gender issues in substance abuse prevention / Louise Ann Rohrbach and Joel Milam -- Preventing substance use among Latino youth / Charles R. Martinez, Jr., J. Mark Eddy, and David S. DeGarmo -- African-American substance use epidemiology and prevention issues / William L. Turner and Michael J. Hench -- The effectiveness of alcohol and drug abuse prevention among American-Indian youth / Fred Beauvais and Joseph E. Trimble -- Drug abuse prevention research for Asian and Pacific Islander Americans / W. William Chen -- VI: INTERACTIONS BETWEEN BIOLOGY AND SOCIAL CONTEXT: RISKS FOR MULTIPLE BEHAVIORAL AND MENTAL DISORDERS: Basic science and drug abuse prevention: neuroscience, learning, and personality perspectives / Michael T. Bardo, Thomas Kelly, Donald R. Lynam, and Richard Milich -- Cross-national comparisons of co-morbidities between substance use disorders and mental disorders / Ronald C. Kessler, Sergio Aguilar-Gaxiola, Laura Andrade, Rob Bijl ... [et al.] -- Drug abuse research for high-risk youth / Leona L. Eggert and Brooke P. Randell -- Research designs for family studies / Michael Vanyukov, Howard Moss, and Ralph E. Tarter -- VII: RESEARCH DESIGN, MEASUREMENT, AND DATA ANALYTIC ISSUES: Design principles and their application in preventive field trials / C. Hendricks Brown -- Major data analysis issues in drug abuse prevention research / David P. MacKinnon and James H. Dwyer -- Metholological considerations to prevention research / Linda M. Collins and Brian P. Flaherty -- Prevention program implementation / Steven Schinke and Kristin Cole -- Family management practices: research design and measurement issues / Thomas J. Dishion, Bert Burraston, and Fuzhong Li -- Power analysis models and methods: a latent variable framework for power estimation and analysis / Terry E. Duncan, Susan C. Duncan, and Puzhong Li -- VIII: DRUG ABUSE PREVENTION: A LOOK TO THE FUTURE: Application of computer technology to drug abuse prevention / Kris Bosworth -- Putting science into practice / Gale Held.
- 2014 CRCnetBASEBerdanier, Carolyn D.; Dwyer, Johanna T.; Heber, David."Beginning with an overview of food and food constituents, the book outlines current nutrient analysis systems, techniques for data analysis, and food labeling. The book reviews nutrition science including terminology, biochemistry, nutrient-nutrient interactions, and comparative nutrition. There is a detailed assessment in section three on nutritional needs throughout the lifecycle. It highlights exercise and the value of vegetarian diets in health promotion and disease prevention. Section four considers issues surrounding nutritional assessment, screening, and monitoring tools including questionnaires, and anthropometric-, psychological-, and energy-assessments--Provided by publisher.
- 2012 SpringerChristenson, Sandra; Reschly, Amy L.; Wylie, Cathy.pt. 1. What is student engagement? -- pt. 2. Engagement as linked to motivational variables -- pt. 3. Engagement and contextual influences -- pt. 4. Student engagement : determinants and student outcomes -- pt. 5. Measurement issues, instruments, and approaches.
- 2008 SpringerHirsch Hadorn, Gertrude.
- 2006Greenhalgh, Trisha.Why read papers at all? -- Searching the literature -- Getting your bearings: what is this paper about? -- Assessing methodological quality -- Statistics for the non-statistician -- Papers that report drug trials -- Papers that report diagnostic or screening tests -- Papers that summarise other papers (systematic reviews and meta-analyses) -- Papers that tell you what to do (guidelines) -- Papers that tell you what things cost (economic analyses) -- Papers that go beyond numbers (qualitative research) -- Papers that report questionnaire research (surveys) -- Getting evidence into practic.
- 2010Greenhalgh, Trisha.Why read papers at all? -- Searching the literature -- Getting your bearings : what is this paper about? -- Assessing methodological quality -- Statistics for the non-statistician -- Papers that report trials of drug treatments and other simple interventions -- Papers that report trials of complex interventions -- Papers that report diagnostic or screening tests -- Papers that summarise other papers (systematic reviews and meta-analyses) -- Papers that tell you what to do (guidelines) -- Papers that tell you what things cost (economic analyses) -- Papers that go beyond numbers (qualitative research) -- Papers that report questionnaire research -- Papers that report quality improvement case studies -- Getting evidence into practice.
- How to write a successful research grant application : a guide for social and behavioral scientists. 2nd ed.2011 SpringerBoyce, Cheryl Anne; Pequegnat, Willo; Stover, Ellen.Grantsmanship : necessary but not sufficient strategies for success / Willo Pequegnat -- Community-based collaborations : designing, conducting and sustaining prevention programs / Mary M. McKay, Carl C. Bell, and Clair A. Blake -- Funding opportunity announcements / Jean Noronha -- Selecting the appropriate research mechanism : finding the right match / Cheryl Anne Boyce and Courtney Ferrell Aklin -- Selecting issues and hypotheses for a research proposal / Spero M. Manson -- Electronic submission process / Jean Noronha -- The review process / Anita Miller Sostek -- Common mistakes in proposal writing and how to avoid them / Susan Folkman and Willo Pequegnat -- Reading between the lines of your summary statement / William Lyman, Bonita Stanton, and Willo Pequegnat -- The award process / Ellen Stover -- So you were awarded your grant, now what? / Seth C. Kalichman -- Developing a theoretical framework and rationale for a research proposal / Gregory M. Herek -- How do you formulate a testable exciting hypothesis? / Robyn Dawes -- Qualitative inquiry : an end not just a means / Margaret E. Bentley, Elizabeth E. Tolley, and Willo Pequegnat -- Issues in assessment in research proposals / Helena Chmura Kraemer -- Using technology and the Internet in research / Joseph A. Konstan and William West -- Designing an intervention / Jose Szapocznik, Willo Pequegnat, and Guillermo Prado -- Designing an adequate control group / Thomas J. Coates -- Human subject protection and special population issues / Christine Moretto Wishnoff ... [et al.] -- Animal welfare and behavior / Kevin Quinn and Richard Nakamura -- Developing a resume and presenting your research team / Rayford Kytle and Cheryl Anne Boyce -- Writing the data analysis plan / A.T. Panter -- Developing a budget and financial justification / Masud Rahman -- Developing a quality control/quality assurance program / Lisa C. Strader and Willo Pequegnat -- Applying for training, career development, and early-stage research grants / Donna Mayo -- Cost-effectiveness : a key step in technology transfer / Steven D. Pinkerton and David R. Holtgrave -- Disseminating research findings to service providers and communities / Jeffrey A. Kelly -- Developing a plan for data sharing / Christine Bachrach and Michael Spittel.
- 2011Day, Robert A.; Gastel, Barbara.What is scientific writing? -- Historical perspectives -- Approaching a writing project -- What is a scientific paper? -- Ethics in scientific publishing -- Where to submit your manuscript -- How to prepare the title -- How to list the authors and addresses -- How to prepare the abstract -- How to write the introduction -- How to write the materials and methods section -- How to write the results -- How to write the discussion -- How to state the acknowledgments -- How to cite the references -- How to design effective tables -- How to prepare effective graphs -- How to prepare effective photographs -- Rights and permissions -- How to submit the manuscript -- The review process (how to deal with editors) -- The publishing process (how to deal with proofs) -- How to write a review paper -- How to write opinion (book reviews, editorials, and letters to the editor) -- How to write a book chapter or a book -- How to write for the public -- How to present a paper orally -- How to prepare a poster -- How to write a conference report -- Use and misuse of English -- Avoiding jargon -- How and when to use abbreviations -- Writing clearly across cultures and media -- How to write science in English as a foreign language -- How to write a thesis -- How to prepare a curriculum vitae -- How to prepare grant proposals and progress reports -- How to write a recommendation letter- and how to ask for one -- How to work with the media -- How to provide peer review -- How to seek a scientific-communication career -- Appendix 1. Selected journal title word abbreviations -- Appendix 2. Words and expressions to avoid -- Appendix 3. Prefixes and abbreviations for SI (système international) units -- Appendix 4. Some helpful websites -- Glossary of technical terms.
- 2010 ProQuest SafariCanavor, Natalie; Canavor, Natalie; Meirowitz, Claire; Meirowitz, Claire."This Element is an excerpt from 'The truth about the new rules of business writing' by Natalie Canavor and Claire Meirowitz. How to write successful proposals and grant applications"--Resource description page.
- 2006 CRCnetBASEPeters, George A.; Peters, Barbara J.
- 90 days to success in grant writing — Human error : causes and control (100)
- Human medical research : ethical, legal and socio-cultural aspects — Role of theory in advancing 21st century biology : catalyzing transformative research : report of Committee on Defining and Advancing the Conceptual Basis of Biological Sciences in the 21st Century, National Research Council. (100)
- Role of purchasers and payers in the clinical research enterprise — Yeast as tool in cancer research (46)
- Harrison's Principles of Internal Medicine
- AAP Red Book Online
- Robbins & Cotran Pathologic Basis of Disease
- Sabiston Textbook of Surgery
- Nelson's Textbook of Pediatrics
- Surgical Exposures in Orthopaedics
- Mandell, Douglas, & Bennett's Principles & Practice of Infectious Diseases
- Red Book Online
- ICU Book
- Primary Care Medicine
- Campbell-Walsh Urology
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