A Manager's Guide to the Design and Conduct of Clinical Trials

This engaging and non-technical guide to clinical trials covers issues study design, organization, management, analysis, recruitment, reporting, software, and monitoring. Free from the jargon-laden treatment of other books, A Manager’s Guide to the Design and Conduct Clinical Trials is built upon the formula of first planning, then implementing, and finally performing essential checks.

• Offers an executive level presentation of managerial guidelines as
  well as handy checklists accompanied by extracts from submitted
  protocols
• Includes checklists, examples, and tips, as well as a useful appendix on available software
• Covers e-submissions and use of computers for direct data
  acquisition
• Incorporates humorous yet instructive and true anecdotes to
  illustrate common pitfalls

The first practical guide to computer-assisted clinical trials written without use of technical jargon, A Manager’s Guide to the Design and Conduct of Clinical Trials provides a comprehensive primer for prospective managers covering every critical issue, including study design, organization, management, and analysis, as well as recruitment, reporting, software, and monitoring.

This step-by-step guide is supported by handy checklists and extracts from submitted protocols. Experienced author and consultant Phillip I. Good incorporates humorous yet instructive anecdotes to illustrate common pitfalls. Based on the proven industrial formula of planning, implementing, and finally performing essential checks, the book’s three sections–"Plan," "Do," and "Check"–include the following material:

• Staffing for success
• Designing trials and determining sample size
• Budgeting
• Exception handling
• Recruiting and retaining patients and physicians
• Data management
• Monitoring the trials
• Data analysis and review

Executive and managerial professionals involved in the design and analysis of clinical experiments, along with clinical research associates, biostatisticians, and students in public health will find A Manager’s Guide to be an indispensable resource.