Review of Clinical Equipoise: Examples from Oncology Trials.

ABSTRACT

BACKGROUND: The current standards that govern clinical research have been shaped over the years through many historical, social, and political events. The third principle of the Belmont Report, Justice, guides the scientific community toward the equal distribution of benefits and risks in research involving human subjects. Clinical equipoise is the status of genuine uncertainty by the investigator about the superiority of one treatment arm over the other. The term clinical equipoise was proposed to provide an ethical ground to conduct randomized controlled clinical trials. OBJECTIVE: The objective of this review is to provide the reader with an overview of the emergence of the term equipoise and its utilization in randomized controlled trials. METHODS: In the current review article, the major oncology clinical trials and relevant patents were reviewed for the application/utilization of clinical equipoise. RESULTS: The concept of clinical equipoise has been challenged, and different alternatives were proposed. Yet, these alternatives received numerous critiques and failed to fully replace equipoise. In addition, several patents related to anticancer agents tested in the described studies were examined. No specific reference was made as part of the patent to the status of clinical equipoise. Alternatively, a description of the study arms was provided. CONCLUSION: There is a need for revisiting the concept of equipoise and its suggested alternatives for its ethical essence while addressing related challenges.