Preventive Misconception in Clinical Trials: Implications for Informed Consent and Racial Disparities

Preventive Misconception (PM) occurs when research participants overestimate the personal benefit they will receive from a clinical trial, which is testing if an agent prevents the recurrence or progression of disease. Although therapeutic misconception (TM) has been extensively studied, PM has not. This study explores the occurrence and implications of PM in participants in the three open prevention trials conducted at Emory Winship Cancer Institute. Participants completed structured qualitative interviews based on a literature review that were cognitively tested for clarity. Interviews were auto-recorded, transcribed, and de-identified. The data were analyzed using Simon et al.’s framework to assess PM prevalence.1 Among the 16 participants, four (25%) exhibited a preventive misconception. Two of the three African American participants exhibited PM, though the small sample size, due to there being only three open PM trials, limits definitive conclusions. Common themes included assumptions of direct personal health protection and underestimation of risks. This study shows that some clinical trial participants exhibit PM, especially in marginalized populations, emphasizing the need for improved informed consent processes. Misconceptions about preventive trials can compromise participant understanding, specifically an overestimation of the direct benefit of the trial. To effectively address PM, creating more precise risk-benefit explanations and interactive consent strategies is essential. Further research with a more diverse and larger sample population is necessary to confirm these findings and develop effective interventions.