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  • Book
    editors, Renato D. Lopes, Robert A. Harrington.
    Summary: Complete how-to guidance on conducting clinical research, this book addresses the operational challenges of clinical trials and provides a clear explanation of the methodologies necessary to interpret results. The book addresses all aspects of clinical trials, from design and implementation to statistics to regulatory scrutiny. A resource for students, residents, and clinicians who need a working knowledge of clinical research principles. The chapter authors are all leaders in the field and engaged in cutting edge clinical research. Use as a textbook, as a reference, and as a course guide for mandated clinical research training courses.

    Contents:
    A brief history of clinical trials, drug regulations, and the Food and Drug Administration / Nidhi Tripathy ... [et al.]
    Information technology, access, clinicaltrials.gov / Anjan Chakrabarti and C. Michael Gibson
    The role of academic research organizations in clinical research / Craig J. Reist ... [et al.]
    Ethics of clinical research : an overview and emerging issues / Yee Weng Wong and Kevin A. Schulman
    Introduction to clinical experimentation / Robert Bigelow
    Phase I trials : first in human / Kevin M. Watt, Karen Chiswell, and Michael Cohen-Wolkoweiz
    Phase II clinical trials / Jeffrey T. Guptill and Karen Chiswell
    Phase III and IV clinical trials / Gail E. Hafley, Sergio Leonardi, and Karen S. Pieper
    Challenges of clinical trials in pediatrics / Kevin N. Turner and P. Brian Smith
    Observational research / Michaela Dinan
    Data resources / Ying Xian
    Observational study designs / Bradley G. Hammill
    Challenges of observational designs / David M. Vock
    Specific regression techniques / Phillip J. Schulte
    Analytical methods of addressing confounding / Eric M. Reyes
    Lessons from notable examples in observational research / Zubin Eapen.
    Digital Access AccessMedicine 2013