Designing Clinical Research: an Epidemiologic Approach, 2nd Ed. Stephen B. Hulley, Steven R. Cummings, Warren S. Browner, Deborah Grady, Norman Hearst, Thomas B. Newman, eds. Philadelphia: Lippincott Williams & Wilkins, 2001. Pages: 352. Price: $39.95. ISBN: 0-7817-2218-7.
Jeffrey J. Walline, The Ohio State University , College of Optometry , Columbus, Ohio
Stephen B. Hulley, Steven R. Cummings, as well as a new and returning cast of characters co-author the second edition of Designing Clinical Research, a text written to guide young investigators through the basics of clinical research. Designing Clinical Research may be used as a cookbook to guide a young research scientist through development of a hypothesis and design of a study to examine the research question. It may also be used to teach students the fundamentals of clinical research or to remind experienced investigators about basic research tasks such as how to estimate a sample size.
The FIGURE basic premise of the first edition remains unchanged: keep it simple. The content throughout the text includes the basic information necessary for rational decisions, but intricacies are left to advanced studies. Concepts are illustrated through flow diagrams, and key concepts are made easy to remember with acronyms. For example, a good research question or study design should be “FINER”: Feasible, Interesting, Novel, Ethical, and Relevant. Appendices, such as random digit and sample size calculation tables, are provided at the end of the appropriate chapters. A few exercises to implement new principles are provided at the end of each chapter, and answers to the questions are given at the end of the book.
The basic concepts of clinical research have not changed so dramatically as to warrant a new edition of Designing Clinical Research, but years of experience teaching and practicing the material contained in the book have helped the authors refine the sequence of the lessons and expand on topics that deserve further attention, such as research ethics.
The first section of the book is largely unchanged, except that it includes information on estimation of sample size, which was presented later in the first edition. The first section explains the purpose of scientific endeavors and introduces the fundamentals of conducting clinical research. Topics range from formation of the research question to issues regarding the appropriate choice of outcome measurements.
Section II describes the various study designs available to answer research questions. Individual chapters are dedicated to the description and implementation of various study designs, such as cohort, cross-sectional, case-control, and observational studies. Two chapters are dedicated to the issues involved in the organization and conduct of clinical trials. A chapter is presented to discuss studies designed to examine the suitability of tests to screen for risk factors or measure study outcomes. The final chapter of the section addresses study design issues using data collected for alternate purposes.
The final section discusses implementation of knowledge gained in the first two sections of the book. Given the recent increased scrutiny of clinical research in the media, greater emphasis on ethical issues is provided in the new edition. Innovations in computer and Internet technology compelled the authors to revise the chapters on survey administration and data management. To obtain a representative sample, investigators often find it necessary to recruit subjects from outside the academic setting and possibly from another country. A new chapter helps young investigators with issues regarding community and international research projects. The final chapter of the book addresses a topic near and dear to all successful research scientists: writing and funding a research proposal.
Designing Clinical Research guides the reader through the fundamentals of scientific investigations and provides clear directions on how to answer research questions. No text book could be “FINER” for a budding scientist about to embark on a career of clinical research.