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  • 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.
  • 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.
  • 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trials -- Sample size and power estimation -- Clinical trial simulation -- Regulatory perspectives : a review of FDA draft guidance.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 2009 ClinicalKey
  • 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.
  • 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.
  • "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.
  • 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.
  • 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.
  • 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.
  • "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.
  • 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.
  • 2012 ClinicalKey
    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.
  • "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."
  • 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.
  • 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.
  • "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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • "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.
  • 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.
  • 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.
  • 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.
  • "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.
  • Part 1. Historical and Socio-Cultural Contexts in Medical Research / British Responses to Nazi Medical War Crimes / Fiona McClenaghan -- History and its Relevance in the Development and Teaching of Research Ethics / Rael D. Strous -- Human Embryo Research and Islamic Bioethics: A View from Iran / Mansooreh Saniei -- From Farming to Pharming: Transcending of Bodily Existence as a Question of Medical Ethics in an Intercultural Context / Axel Siegemund -- Introduction / Jan Schildmann, Verena Sandow, Oliver Rauprich and Jochen Vollmann -- Part 2. Considerations on Ethical and Legal Regulations for Medical Research / Rethinking the Therapeutic Obligation in Clinical Research / Nunziata Comoretto -- Biomedical Research in Developing Countries and International Human Rights Law / Ilja R. Pavone -- Research Involving Human Subjects and Human Biological Material from a European Patent Law Perspective. Autonomy, Commodification, Patentability / Tomasz Zimny -- The Development and Validation of a Guide for Peruvian Research Ethics Committees to Assist in the Review of Ethical-Scientific Aspects of Clinical Trials / Susy Olave Quispe, Duilio Fuentes Delgado, Gabriela Minaya Martínez, Rosa Surco Ibarra and Martín Yagui Moscoso, et al. -- Part 3. Conflicts in Medical Research / Conflicts of Interest in Medical Research: What can Ethics Contribute? / Verena Sandow, Jan Schildmann and Jochen Vollmann -- Research Ethics in Genomics Research: Feedback of Individual Genetic Data to Research Participants / Annelien L. Bredenoord and Johannes J. M. van Delden -- Regulating "Higher Risk, No Direct Benefit" Studies with Children: Challenging the US Federal Regulations / Anna E. Westra, Jan M. Wit, Rám N. Sukhai and Inez D. de Beaufort -- Part 4. New Developments in Medical Research and Ethical Implications / A Paradigm Change in Research Ethics / Rieke van der Graaf and Johannes J. M. van Delden -- Translation of Cancer Molecular Biomarkers: Ethical and Epistemological Issues / Flavio D'Abramo and Cecilia Guastadisegni -- Rethinking the Ethics of Human Biomedical Non-Interventional Research / Kristi L{tilde}ouk.
  • Part 1. Tools -- part 2. Practices and guidelines -- part 3. Platforms.
  • A collection of syntheses of the international scientific literature and recommendations on public health problems, by Inserm's expert advisory groups.
  • "Preface The aim of this book is to present in a single volume an overview and latest developments in time-to-event interval-censored methods along with application of such methods. The book is divided into three parts. Part I provides an introduction and overview of time-to-event methods for interval-censored data. Methodology is presented in Part II. Applications and related software appear in Part III. Part I consists of two chapters. In Chapter 1, Sun and Li present an overview of recent developments, with attention to nonparametric estimation and comparison of survival functions, regression analysis, analysis of multivariate clustered- and analysis of competing risks interval-censored data. In Chapter 2, Yu and Hsu provide a review of models for interval-censored (IC) data, including: independent interval censorship models, the full likelihood model, various models for C1, C2, and MIC data as well as multivariate IC models. Part II consists of seven chapters (3-9). Chapters 3, 4 and 5 deal with interval-censored methods for current status data. In Chapter 3, Banerjee presents: likelihood based inference, more general forms of interval censoring, competing risks, smoothed estimators, inference on a grid, outcome misclassi- cation, and semiparametric models. In Chapter 4, Zhang presents regression analyses using the proportional hazards model, the proportional odds model, and a linear transformation model, as well as considering bivariate current status data with the proportional odds model. In Chapter 5, Kim, Kim, Nam and Kim develop statistical analysis methods for dependent current status data and utilize the R Package CSD to analyze such data"-- Provided by publisher.
  • This book is all about the definition and finding ways to prioritize and accelerate translation research in biomedical sciences and rapidly turning new knowledge into first-in-human studies. It represents an effort to bring together scientists active in various areas of translational research to share science and, hopefully, generate new ideas and potential collaborations. The book provides a comprehensive overview of translational work that includes significant discoveries and pioneering contributions, e.g., in immunology, gene therapy, stem cells and population sciences. It may be used as an advanced textbook by graduate students and even ambitious undergraduates in biomedical sciences. It is also suitable for non-experts, i.e. medical doctors, who wish to have an overview of some of the fundamental models in translational research. Managing the translational enterprise remains a work in progress. The world is changing rapidly, and the scientific world needs to seek new ways to ensure that discoveries get translated for patients efficiently and as quickly as possible. In addition, everyone expects the investment in biomedical research should pay dividends through effective therapeutic solutions. This unique project provides a broad collaborative approach of the international scientific team to present its view and opinion how to cross barriers to incentives for translational research in medical sciences. Contributing to the book is an international team of prominent co-authors. The book consists of unique and widely treated topics, and includes new hypotheses, data and analyses.
  • This self-help guide is intended for scientists and medical professionals and students who wish to improve their scientific writing skills. Exercises invite the reader to practice the most important aspects of scientific writing. Although the book addresses certain issues more troublesome to scientific communicators of a non-English language origin, the guide will be of equal benefit to those whose first language is English. If you want not only to write but to write well, this book is for you. This second edition takes into account new developments in the area of scientific communication. In particular, the importance of authenticity is addressed, drawing attention to the sensitive issue of plagiarism in scientific texts.
  • "Emphasizing applications over theory, this book provides a comprehensive survey of this method and provides readers with standards and directions on how to run sound clinical and other types of studies. The author clearly explains how to reduce measurement error and presents numerous practical examples of the interobserver agreement approach. To help with problem solving, he includes SAS code, both within the book and on the CRC website. An extensive review of the literature offers access to the latest developments in the field. This edition presents new applications, new tables, more detail on SAS, new code, updated references, and two new chapters"--Provided by publisher.
  • Getting Started in Medical Writing -- Basic Writing Skills -- From Page One to the End -- Technical Issues in Medical Writing -- What's Special About Medical Writing? -- How to Write a Review Article -- Case Reports, Editorials, Letters to the Editor, Book Reviews, and Other Publication Models -- Writing Book Chapters and Books -- How to Write a Research Protocol -- How to Write a Grant Proposal -- How to Write a Report of a Clinical Study -- Getting Your Writing Published.
  • Physician-scientists are unusual creatures. While we are drawn to the clinical challenges of our patients, we are also drawn to the opportunities that our patients' medical problems bring to science. This book contains the unique experiences and encounters that drew 21 accomplished physician-scientists to this profession. These personal stories are those of people and circumstances that have had profound effects on our career decisions, our creative opportunities, and our lives. These stories also serve to highlight the lessons learned along the way and the distinct attributes of these women and men of medicine and science. Our combined hope is that our collective biographies will enhance the public understanding of our profession, will move people from medicine to science and from science to medicine, and will inspire those who are contemplating this extraordinary profession.
  • MRC applied psychology Unit 2003
    Wellcome Trust
    "This transcript considers the origins and impact of the MRC Applied Psychology Unit's work from 1944 to 1998."
  • 1. Multiplicity problems in clinical trials : a regulatory perspective / Mohammad Huque and Joachim Rèohmel -- 2. Multiple testing methodology / Alex Dmitrienko ... [et al.] -- 3. Multiple testing in dose-response problems / Frank Bretz, Ajit C. Tamhane, and Josâe Pinheiro -- 4. Analysis of multiple endpoints in clinical trials / Ajit C. Tamhane and Alex Dmitrienko -- 5. Gatekeeping procedures in clinical trials / Alex Dmitrienko and Ajit C. Tamhane -- 6. Adaptive designs and confirmatory hypothesis testing / Willi Maurer, Michael Branson, and Martin Posch -- 7. Design and analysis of microarray experiments for pharmacogenomics / Jason C. Hsu ... [et al.].
  • Introduction -- The science of developing cancer therapy -- Operations, oversight, and funding of cancer clinical trials -- Physician and patient participation in cancer clinical trials.
  • Neural Development -- Visual Perception -- Tactile Perception -- Skin And Environment -- Conclusion: Neuromedia: Talking into the Future.
  • Includes all of words, phrases, and translations, in French, German, Spanish and Italian from the print dictionaries. Users can search the full A-Z from both sides of the dictionary in Oxford's unabridged bilingual dictionaries: French, German, Spanish, and Italian.
  • pt. 1. Getting started as physician-scientist. -- Beginnings -- Is a physician-scientist career right for you? -- Training as a physician-scientist -- pt. 2. Launching your career as a physician-scientist. -- Getting a job -- Appointments, tenure, promotions, and sabbaticals -- Teaching -- Administration -- Research -- pt. 3. Building your career as a physician-scientist. -- Writing -- Publishing -- Grants -- Grantsmanship -- Peer review of grant applications -- Managing your team, time, and money -- Mentorship -- Lectures and presentations -- Relations with industry -- pt. 4. Parting words of advice : putting it all together. -- Balancing research, clinical activities, and family life -- Improving the physician-scientist pathway -- Concluding remarks.
  • The conceptual underpinnings of statistical power -- Strategies for increasing statistical power -- General guidelines for conducting a power analysis -- The t-test for independent samples -- The paired t-test -- One-way between subjects analysis of variance -- One-way between subjects analysis of covariance -- One-way repeated measures analysis of variance -- Interaction effects for factorial analysis of variance -- Power analysis for more complex designs -- Other power analytic issues and resources for addressing them.
  • This expanded third edition provides an introduction to the conduct of clinical research as well as more comprehensive and expansive content about the infrastructure necessary for a successful clinical research organization or enterprise. With authors who are experts in clinical research in both the public and private sectors, this publication provides essential information to clinical investigators who wish to develop and conduct well designed patient-based research protocols that comply with rigorous study design, ethical, and regulatory requirements.
  • Basic biostatistics for the clinical trialist / Elizabeth G. Hill and Elizabeth Garrett-Mayer -- Fundamental concepts in clinical pharmacology / Daniel L. Gustafson and Erica L. Bradshaw-Pierce -- Bioanalycial methods in clinical drug development / Walter J. Loos, Peter de Bruijn and Alex Sparreboom -- Preclinical models for anticancer drug development / Edward A. Sausville -- Phase I clinical trials with anticancer agents / Stephen Leong ... [et al.] -- Phase II trials with anticancer agents / Hui K. Gan, J. Jack Lee and Lillian L. Siu -- Phase III clinical trials with anticancer agents / Wendy R. Parulekar and Daniel J. Sargent -- Pharmacokinetic studies in early anticancer drug development / Alex Sparreboom and Sharyn D. Baker -- Pharmacodynamic studies in early phase drug development / D. Ross Camidge, Robert C. Doebele and Antonio Jimeno -- Prediction of antitumor response / Fred R. Hirsch and Yu Shyr -- Imaging studies in anticancer drug development / David A. Mankoff -- Role of the U.S. Food and Drug Administration in cancer drug development / Ann T. Farrell, Ramzi N. Dagher and Richard Pazdur -- Early clinical trials with cytotoxic agents / M.J.A. de Jonge and Jaap Verweij -- Challenges and successes in developing effective anti-angiogenic agents / Laura Q.M. Chow and S. Gail Eckhardt -- Targeted therapeutics in cancer treatment / Colin D. Weekes and Manuel Hidalgo -- Cancer chemoprevention / Christopher H. Lieu, William N. William Jr. and Scott Lippman -- Combined modality therapy in cancer management / David Raben and Kyle Rusthoven -- Cancer vaccines / Daniel Laheru -- Optimising the development of antibodies as treatment for cancer / Craig P. Carden, Hendrik-Tobias Arkenau and Johann S. de Bono -- Oligonucleotide therapeutics / Cy A. Stein, Britta Hoehn and John Rossi -- Anticancer drug development in pediatric patients / Lia Gore and Margaret Macy -- Clinical trials in special populations / S. Percy Ivy ... [et al.] -- NCI-sponsored clinical trials / Andriana Papaconstantinou and Janet E. Dancey.
  • Print Material
    Introduction and definitions -- Target identification and validation -- Biomarkers -- Early clinical trial design -- Pharmaceutical toxicology -- Translational science biostatistics -- Learning by experience : examples of translational processes in the cardiovascular field.
  • Background -- Scope, goal, objectives and target audience -- Global burden of NCDs -- Role of research in the implementation of the Global Strategy Action Plan -- Need for a prioritized research agenda for prevention and control of major NCDs to improve public health -- Achievable outcomes through a prioritized research agenda for prevention and control of major NCDs -- Process for the development of the WHO NCD research agenda. Initial phase of development of the WHO NCD research agenda -- Ranking process -- Finalization of WHO NCD research agenda -- Key domains for research. Major NCDs. Cardiovascular disease (CVD) -- Cancer -- Chronic respiratory diseases -- diabetes -- NCD risk factors. Tobacco control -- Nutrition, physical activity and obesity -- Cross-cutting domains. Primary health care approach for prevention and control of NCDs -- Social determinants and NCDs -- Genetics -- Promoting use of research findings to policies and practice for prevention and control of noncommunicable diseases -- Top 20 priority areas for NCD research -- Key elements required for strengthening the research capacity of low- and middle-income countries for implementation of the WHO NCD research agenda. Contents of the compact disc: -- 1. Working papers -- 2. Reports of Meetings to develop the Prioritized NCD research agenda (2008-2010) -- 3. Lists of participants -- 4. List of other contributors and institutions that participated in the process of development and review of the prioritized NCD research agenda.
  • "Nonpharmacological treatments include a wide variety of treatments such as surgery, technical procedures, implantable devices, nonimplantable devices, rehabilitation, psychoteherapy, and behavioral interventions. This book focuses on the methods of assessing nonpharmacological treatments, highlighting specific issues and discussing all possible design of trials. It provides practical examples to underline the issues and solutions in assessing nonpharmacological treatment in trials. Arguably the first book to exclusively explore this topic, it discusses various categories of treatments from surgical procedures to psychotherapy"--Provided by publisher.
  • Cancer continues to be one of the major causes of death throughout the developed world, which has led to increased research on effective treatments. Because of this, in the past decade, rapid progress in the field of cancer treatment has been seen. Recent Advances in Cancer Research and Therapy reviews in specific details some of the most effective and promising treatments developed in research centers worldwide. While referencing advances in traditional therapies and treatments such as chemotherapy, this book also highlights advances in biotherapy including research using Interferon and Super.

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A repository of medical knowledge from internal medicine, cardiology, genetics, pharmacy, diagnosis and management, basic sciences, patient care, and more. Continuously expanding, all databases in the repository contain the latest editions of selected medical titles.MicroMedex: Premier pharmaceutical information source containing multiple databases and drug reference tools. Of particular value is DRUGDEX Evaluations, one of the most comprehensive drug sources available.DynaMed is a clinical information resource used by physicians to answer clinical questions quickly and easily at the point of care. Topics are updated daily as new evidence becomes available. 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