Table of Contents
Overview of Trial Design Options: Adults (Challenges in Clinical Trials in People for Whom Available Therapies have Failed )
WARNING
Randomized Controls or Not?
Tuberculous Meningitis
Tuberculous Meningitis
PPT Slide
PPT Slide
Increasing Heterogeneity
Increasing Heterogeneity 2
Increasing Heterogeneity 3
Selected variables predicting decline of pVL < 400 (Multi-drug Rescue Therapy - Montaner et al)
PPT Slide
PPT Slide
PPT Slide
Can we avoid randomized trials?
Gastric Freezing for DU
Gastric Freezing for DU
VA Study - Estrogen & Prostate Ca
Uncontrolled Phase II Cancer studies
Traditional Orthodoxy
Role of Observational Data
Role of Observational Data
Non-randomized concurrent comparisons by post-randomization variables
Analysis by post-randomization adherence in a lipid lowering trial
Analysis by post-randomization adherence in a lipid lowering trial
Salvage Therapy and Non-randomized Controls
Salvage Therapy and Non-randomized Controls
Control of Confounders
Remedies for Confounding in Smaller Sample Sizes
There is no within-study remedy for lack of power in smaller sample size studies!
The Need for Blinding?
The Need for Blinding?
The Need for Blinding?
The Need for Blinding - An example
PPT Slide
PPT Slide
Particular Clinical Trial Challenges
Clinical Trial Challenges
Factorial Designs - Illustration
ACTG 359 (2 x 3 Factorial)
OPTIMA (2 x 2 Factorial)
Randomised trial of effects of vitamin supplements on pregnancy outcomes and T cell counts in HIV-1-infected women in Tanzania Fawzi WW et al. Lancet 1998; 351:1477-82.
Stratified Factorial
Factorial Designs
Latin Squares
Factorial Designs
Factorial Designs
Drug-wise vs. Strategy-wise Evaluation
Drug-wise Evaluation
Strategy-wise Evaluation 1
Strategy-wise Evaluation 2
Miscellaneous Considerations
Cost-Effectiveness Considerations
Some Comparators (US$ per QALY)
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