Why Randomized Phase III Clinical Trials??
:Why Randomized Phase III Clinical Trials?? Because what is logical and should work often doesn’t: Identifying new superior treatments is an empirical, not a deductive process Example: Anti-arrhythmic therapy to prevent mortality from fatal arrhythmias 1. Elevated VPBs are associated with early death 2. Encainide and flecainide suppress VPBs 3. Therefore, encainide and flecainide should reduce mortality in patients with VPBs WRONG! Why Randomized Phase III Clinical Trials?? :Why Randomized Phase III Clinical Trials?? Need reliable answers to questions of therapy: Example: Accepting a more toxic therapy as superior when it is not better than standard therapy has serious consequences for future patients. Conclusions from single arm (non-randomized) clinical trials have limited reliability: Apparent improvements ascribed to treatment are often due to patient selection (selection bias) Historical control populations may differ from current study populations Improvement ascribed to one inte
