Ethical analysis reveals limitations of equipoise in novel oncology trials, suggesting additional oversight frameworks are required to monitor participant risks.
Key Points
To examine the theoretical and practical challenges novel oncology trial designs pose to the traditional concept of equipoise in clinical research ethics.
Conducted a conceptual and ethical evaluation of equipoise within non-traditional randomized controlled trial frameworks in oncology.
Assessed ethical tensions in specific modern paradigms, including seamless-phase designs, platform or 'immortal' trials, and adaptive trial techniques.
Identified that dynamic structural changes and evolving allocation rules in adaptive and seamless trials undermine traditional static definitions of equipoise.
Demonstrated that relying solely on equipoise is insufficient for modern trial designs, requiring complementary ethical tools to address novel participant risk profiles.