Equipoise abandoned? Randomization and clinical trials
Randomized, clinical trials are the strongest method we have to define the efficacy of new drugs. Recently, however, novel agents that show remarkable responses with minimal toxicity in patients with advanced cancer have been discovered [1], and these present a challenge for the ethical conduct of randomized trials. Consequently, there is a debate on the randomized trial as the gold standard for bringing these agents to approval. For several decades, the standard for determining that a randomized trial is ethical has been a matter of discussion. Some doctors espouse the…