Overcoming the barriers to early-phase clinical trials (EPCT): Increasing EPCT minority accrual.

Abstract

e16566 Background: Increasing minority accrual is critical to the development of novel cancer therapeutics. Without adequate minority representation in EPCT, researchers cannot assess differential effects among groups nor ensure the generalizability of trial results. Little is known about cultural factors that impact the decision to participate in EPCT among Hispanics. Methods: The goals of this research were to identify cultural, economic and environmental barriers to EPCT accrual and potential interventions to reduce these barriers. Two surveys were conducted. One survey was with 114 oncologists and one with 100 cancer patients (50 who were enrolled in an EPCT and 50 who never participated). Results: The top four logistical barriers stated by oncologists were all related to the extra work and time of recruiting and referring patients: referring patients is extra work (63%), too much paperwork (57%), too complex of procedures (57%) and excessive details of protocols (50%). Significant differences between clinical trial and non-clinical trial participants were found for two barriers in the decision-making process [lack of knowledge about available trials (88% and 94%), and lack of understanding about trial processes and purpose due to medical jargon (82% and 90%)]. Non-clinical trial participants gave higher importance to four barriers related to attitudes and beliefs [fear of being a guinea pig (80%), fear that the experiment is more important than the patient (76%), distrust in the medical system (72%), and fear of sacrificing QoL (72%)]. Non-participants in EPCT tended to have less education, lower income, and were Hispanic. In addition, two-thirds (68%) of non-participants considered language as a major barrier. Conclusions: Oncologists would be more likely to refer patients for EPCT if they are aware of the studies, feel confident with their patients, trust the research team, see benefit for their patients, and have an easy way to refer patients. The results of this study may have implications in terms of message development for groups traditionally underrepresented, which may require language appropriate materials, more visual materials with lower reading levels, and with more precise economic information.