Clinical Trials Design, Third Edition (2000)

Stark NJ, Clinical Trials Design, Third Edition, Clinical Device Group Inc, Chicago, IL (2000). Perfect bound, illustrated, 300 pages. ISBN 1-889160-02-4. $250 US.

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. Click for author's notes or to order.

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