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The tyranny of non-inferiority trials.
Lancet Oncol
October 2024
Optimal Cancer Care Alliance, Ann Arbor, MI, USA; Veterans Affairs Center for Clinical Management Research, Charles S Kettles VA Medical Center, Ann Arbor, MI, USA; Division of Oncology and Lung Precision Oncology Program, University of Michigan Division of Hematology/Oncology, Rogel Cancer Center, Institute for Health Policy and Innovation, and Center for Global Health Equity, Ann Arbor, MI, USA.
Article Synopsis
- Current treatment options are limited by the expectation that alternative therapies must be proven "non-inferior" to existing ones, making trials expensive and complex.
- Non-inferiority trials often overlook important factors like variability in treatment outcomes and place excessive burdens of proof on alternatives, especially in terms of toxicity and cost.
- The authors suggest moving away from labeling trials as superiority or non-inferiority, advocating instead for a simpler description of trials as "comparative" to promote better patient-centered treatment options.