Increasing minority participation in clinical trials

There is a growing awareness of racial and ethnic disparities in health and the need for health care systems to accommodate increasingly diverse patient populations; the same is true for clinical research systems and institutions. Despite the NIH guidelines on inclusion of Women and Minorities as Subjects in Clinical Research, only 11% of cancer patients enrolled in national publicly funded treatment trials are ethnic/cultural minorities.

Optimal communication between oncology provider and patient is critical to ensuring quality care. This is especially true when a provider is presenting treatment options that should include clinical trials, if one is available for that patient. Many researchers experience difficulties when discussing trial participation, leading to poor accrual to trials and questionable quality of informed consent.  The Education Network to Advance Cancer Clinical Trials (ENACCT) and Cross Cultural Health Care Program (CCHCP), along with community partners funded by the Lance Armstrong Foundation, conducted a qualitative needs assessment of researcher concerns about clinical trial barriers, recruitment, and retention. Findings showed that investigators and their staff often lacked information and training necessary for conducting culturally competent community outreach and education programs about clinical trials.  Clinical trial teams need training on culturally competent and linguistically appropriate care at each and every point of the patient encounter in the research setting – from recruitment to consent to retention.  Although there are numerous courses addressing cultural competency in the clinical setting, the training developed by the Cross Cultural Health Care Program (CCHCP) and the Education Network to Advance Cancer Clinical Trials (ENACCT) is the only course focused on recruitment and retention that is grounded in cultural competency with a strong foundation on incorporation of Culturally and Linguistically Appropriate Services (CLAS) Standards.

Changing provider-researcher behaviors through educational efforts presents a formidable challenge.  First, these individuals see themselves first and foremost as researchers; a focus on culturally competency often seem superfluous to their work. Second, their time is valuable and they may find it difficult to spend time in a training program. ENACCT and CCHCP have successfully addressed these barriers in four important ways:  

•  Meeting with practice administrators to better understand their research staff time and struggle with patient accrual; any negative attention they’ve received from the NCI regarding minority accrual; any studies that have had to close due to poor enrollment; and their requirements for recruitment and retention planning
• Convincing  practice administrators to require/encourage attendance at the training
• Utilizing influential local experts to supplement the training
• Basing the course on effective continuing education principles for health care professionals by
• helping physicians solve problems they recognize;
• enabling physicians to be involved in their own learning;
• utilizing time efficiently, including breakfast, evening programs; and
• by demonstrating how what is learned can be applied in their practice immediately and easily.
  

The course has now been delivered 5 times and refined based on participant evaluation. Detailed strategies, research findings and course content will be shared during the session.