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Planning Clinical Research

  • Date Published: October 2016
  • availability: Available
  • format: Paperback
  • isbn: 9780521549950


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About the Authors
  • Planning a clinical study is much more than determining the basic study design. Who will you be studying? How do you plan to recruit your study subjects? How do you plan to retain them in the study? What data do you plan to collect? How will you obtain this data? How will you minimize bias? All these decisions must be consistent with the ethical considerations of studying people. This book teaches how to choose the best design for your question. Drawing on their many years working in clinical research, Nancy G. Berman and Robert A. Parker guide readers through the essential elements of study planning to help get them started. The authors offer numerous examples to illustrate the key decisions needed, describing what works, what does not work, and why. Written specifically for junior investigators beginning their research careers, this guide will also be useful to senior investigators needing to review specific topics.

    • Over 200 examples in multiple research areas illustrate different issues in clinical study design, including examples illustrating what does not work
    • Many of the examples are presented in several parts, illustrating the thought process involved in planning a study
    • In addition to separate chapters on ethical issues and informed consent, the authors discuss specific ethical issues arising from the activities discussed in each chapter
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    Product details

    • Date Published: October 2016
    • format: Paperback
    • isbn: 9780521549950
    • length: 440 pages
    • dimensions: 248 x 174 x 23 mm
    • weight: 0.73kg
    • availability: Available
  • Table of Contents

    Part I. Introduction:
    1. Questions before starting on the details
    2. Ethics
    3. Informed consent
    Part II. Study Designs:
    4. Overview of study designs
    5. Designs for interventional studies
    6. Cohort studies
    7. Case-control studies
    8. Cross-sectional studies
    9. Record reviews
    10. Selecting a design
    Part III. Core Concepts Applicable to All Study Designs:
    11. Generalizability and validity
    12. Study population
    13. Getting and keeping participants
    14. Study data - how variables are used
    15. Study data - endpoints
    16. Predictor and confounding variables
    17. Bias
    18. Avoiding bias
    Part IV. Additional Concepts for Interventional Studies:
    19. Describing your intervention
    20. Randomization - what and why
    21. Techniques for randomization
    22. Blinding
    23. Techniques needed for blinding intervention studies
    24. Compliance and adherence
    Part V. Additional Concepts for Observational Studies:
    25. Defining populations for cohort studies
    26. Identifying participants for case-control studies
    27. Matching in nonrandomized studies
    28. Blinding in observational studies
    Part VI. Practical Issues:
    29. Acquiring high-quality data
    30. Data storage.

  • Resources for

    Planning Clinical Research

    Robert A. Parker, Nancy G. Berman

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  • Authors

    Robert A. Parker, Harvard Medical School, Massachusetts
    Robert A. Parker has been a consulting biostatistician for nearly forty years. He has worked in academic medicine, industry (a top 25 global pharmaceutical company) and government (the World Health Organization and the US Centers for Disease Control). In industry, he was the arbiter of statistical methods for more than 100 statisticians in the company. Having worked with junior investigators for most of his professional life, he is dedicated to mentoring the next generation of medical researchers. This book reflects his passion to train junior investigators in the art of clinical research.

    Nancy G. Berman, Harbor-UCLA Medical Center
    Nancy G. Berman has been a consulting biostatistician for more than thirty-five years. She has worked in private consulting for the US National Institutes of Health (NIH) and other government studies. In Los Angeles, she was chairperson of the annual Statistical Workshop and Treasurer for the Southern California Statistical Association. As the General Clinical Research Centers statistician and consultant at the Harbor-UCLA Medical Center, she worked with both junior and senior investigators developing protocols for clinical studies. Doing this work she identified the need for a book that would provide details of clinical design in an accessible format for all investigators. Planning Clinical Research is intended to fulfill that need.

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