Overview

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.

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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 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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