Adaptive Clinical Trials: Innovations in Trial Design, Management, and Analysis

By Hermann A.M. Mucke, PhD
 

SURVEY QUESTIONS

Objective: To illuminate current practices, plans, and views regarding adaptive designs for clinical trials.

Participation: Individuals in industry and academic/nonprofit R&D involved with the design, planning, conduct, or monitoring of Phase II, Phase III, or Phase IV clinical trials.

1. Please classify your organization.
 
2. What is the function of your department?

3. What is your job title?
 
4. How many people directly report to you?
 
5. What is your involvement with clinical trials?
 
6. How many Phase II, III, or IV clinical trails did your company conduct in 2006 through the first quarter of 2007?
 
7. Please select the strategies employed at least once during any of these trials.
 
8. What specific types of adaptive designs have you used?
 
9. Describe your experience with flexible or adaptive trial designs.
 
10. If you have used adaptive designs, what specific benefits have you realized?
 
11. What sources most influenced your decision to consider a flexible or adaptive trial design?
 
12. When do you plan to conduct the next adaptive design trial at your company?
 
13. How do you plan to execute your next adaptive trial?
 
14. Would you recommend disclosing the adaptive design nature of a trial?

15.  What major obstacles do you see with adaptive trials?

16. What major points do you see in favor of adaptive designs?

17. When do you think that widespread use of adaptive trial designs will occur?

18. Do you think that certain adaptive trial designs might become mandatory at some point?