Communicating About Phase I Trials: Objective Disclosures Are Only A First Step

Intellectual property rights/inventor/patent holder; (SAB) Scientific advisory board In a recent issue of The Oncologist, Fallowfield et al. [1] responded to long-standing and ongoing concerns that flawed understanding and expectations drive patients’ agreements to participate in early-phase cancer clinical tri-als. As it has evolved from its first use 30 years ago [2], the term “therapeutic misconception ” (TM) captured the dis-comfiting notion that patients perceive and seek potential personal benefit arising from early-phase trial participation when in fact such trials are neither designed nor likely to benefit participants. The vulnerability of the affected popu-lation, patients who face imminent death from cancers for which no established treatment exists and who rely on on-cology professionals for treatment options, fueled ethical concerns that the medical research community, even inad