Removing barriers to participation in clinical trials, a conceptual framework and retrospective chart review study

Trialsjournal: 12/10/12

Background

Enrollment in interventional therapeutic clinical trials is a small fraction of all patients who might participate given reasonable access.

Methods

A hierarchical approach is utilized in measuring staged participation from trial availability to patient enrollment. Our framework suggests that concern for justice comes in the design and eligibility criteria for clinical trials; attention to beneficence is given in the eligibility and physician triage stages. The remaining four stages rely on respect for persons. An example is given where reasons for nonparticipation or barriers to participation in prostate cancer clinical trials are examined within the framework. In addition, medical oncology patients with an initial six month consultation are tracked from one stage to the next by race using the framework to assess participation comparability. Read more