Barriers to Clinical Trial Participation

The project seeks to understand barriers to and document disparities in clinical trial participation in order to increase participation rates in studies, particularly in communities not represented in lung cancer clinical trials.

For new treatments to get approved, it is essential that patients participate in clinical trials. In an iconic study conducted by Comis and colleagues, 33% of adult Americans reported that they would participate in a clinical trial if asked to do so. Despite these positive statistics, real-world participation in clinical trials is low. Only 3% of cancer patients participate in a clinical trial.

The contribution of patient–related (lack of awareness and empowerment, lack of incorporation of patient-centric endpoints), physician-driven (hesitation to recommend trials, patient education), and industry/investigator-initiated (restrictive inclusion and exclusion criteria, lack of transparency in data sharing) barriers to this low rate of participation cannot be underestimated. In addition, structural barriers such as travel to clinical trial sites, high cost of trial participation, and lack of availability of clinical trials close to a lung cancer patient perpetuate health disparities such as lower participation of African American and Hispanic patients, and patients who live in rural areas.

The Foundation has conducted several studies to understand barriers to clinical trial participation and document disparities in lung cancer clinical trial participation.

Results to Date

  1. Barriers to clinical trial participation as reported by lung cancer patients or their caregivers
  2. Geographic relationship between lung cancer clinical trial sites and patient prevalence and demographics in the Medicare Fee-for-service program (Basu Roy et al, poster, National Minority Quality Forum)