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

By Hermann A.M. Mucke, PhD
 

TABLES

Table 2.1. Selection of Large and/or Complex Phase III Clinical Trials Reported since 2003

Table 3.1. Patients Who Experienced at Least 1 Severe Infection Event on the Date of the 3 Simulated Bayesian Analyses, Cotrimo-CI ANRS 059 Trial

FIGURES

Figure 3.1. Interactions Between Hypotheses, Data Evidence, and "Investigator Belief" in Bayes’ Theorem

Figure 3.2. CTriSoft International’s ExpDesign Suite Simulating an Adaptive Clinical Trial

Figure 4.1. Efficacy-Toxicity Trade-off Contour Map to Define Doses in a Phase I/II Hybrid Design

Figure 4.2. Conventional Versus "Seamless" Approach to Phases II and III

Figure 5.1. Summary of FDA Practice in Adaptive Approaches as of September 2002

Figure 6.1. Survey Respondents by Sector

Figure 6.2. Survey Respondents by Department Function

Figure 6.3. Survey Respondents by Position

Figure 6.4. Survey Respondents by Management Level

Figure 6.5. Involvement with Clinical Trials

Figure 6.6. Number of Phase II, III, or IV Clinical Trials Conducted

Figure 6.7. Strategies Used During Clinical Trials

Figure 6.8. Experience with Flexible or Adaptive Trial Designs

Figure 6.9. Benefits Attained from the Use of Adaptive Designs

Figure 6.10. Motivation to Consider a Flexible or Adaptive Trial Design

Figure 6.11. Company Time Frames for Conducting Next Adaptive Trial

Figure 6.12. Disclosure of Adaptive Trial Design

Figure 6.13. Obstacles to Adaptive Trials

Figure 6.14. Advantages of Adaptive Trials

Figure 6.15. Future of Adaptive Trial Designs

Figure 6.16. Opinions as to Mandatory Adaptive Trial Designs