Designing a study means relating the protocol to the ultimate business and science goals of the device. The third edition provides insightful strategies for writing protocols, making design choices, and manipulating sample sizes; then goes a step beyond to give valuable example sponsor documentation tools. The comprehensive information used for the Clinical Trials Design seminar is gathered together in this valuable, 300+ page reference work. Tables and illustrations For more details consult our catalog.
Contents
1. Types of
Trials
2. Claims Substantiation—the Reason for Clinical Trials
3. Protocol Development Alpha
4. Design Considerations
5. Sample Size Calculations
6. Protocol Design Beta
7. Writing Consents
8. Case Report Forms
9. Investigator’s Brochure
10. Other Study Documents
11. Infrastructure
12. Data Management
13. Investigational Device Exemptions from FDA
14. Post-Market Surveillance Studies
15. Diagnostic Device Trials
Bibliography
Stark NJ, Clinical Trials Design, Third Edition,
Clinical Device Group Inc, Chicago, IL (2000).
Perfect
bound, illustrated, 250 pages. ISBN 1-889160-01-6. $250
US.