Planning Clinical Research

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.

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.