National Medical Association Program Seeks to Increase Minority Participation in Clinical Trials
Less than 20% of African-Americans, Hispanics and Asians in the U.S. say they or a family member have ever participated in clinical trials, according to a survey commissioned by Research!America. This lack of inclusion of minority patients can negatively impact the quality of care provided to these patients and ultimately contribute to health disparities. Oftentimes, much of the data supporting approval of new drugs in America is based on clinical trials in non-U.S. populations that poorly reflect American diversity. The lack of U.S. data is, in large part, due to the “difficulty” in recruiting American patients to clinical trials, and represents a barrier to precision medicine.
Project IMPACT, a program of the National Medical Association, stands for Increase Minority Participation and Awareness of Clinical Trials. Our mission is to improve the validity of clinical trials data informing the safe and effective use of medicines in African-American and other ethnic minority patients in America.
Our program has included:
- Educating minority populations about the need to participate in clinical trials, and informing them of the benefit, values, and protections in the process;
- Educating physicians about clinical research and training them to participate as clinical trial investigators;
- Advocating to sponsors on the medical, scientific, and business benefits of clinical drug trial representation reflective of disease prevalence;
- Advocating to policymakers and sponsors for initiation and support of policies to assure ethnic minority inclusion in clinical trials, and diverse inclusion at every level of the clinical research process (e.g., trial designers, IRB members, advisory committee members, etc.) as a means of establishing its trustworthiness.
For many years Project IMPACT has designed, developed and conducted programs to raise awareness in communities and train physicians as investigators and equipped them with tools to manage the regulatory, business and cultural issues in the conduct of trials involving minority patients. Our challenge now is to evolve to accommodate the realities of a new health care environment – electronic record “intrusion” into visit, stricter visit and treatment protocols, less physician independent decision-making, new technology, patient information access and empowerment and more.
Much attention has been directed towards challenging clinical trial sponsors to use more effective outreach strategies for including minority patients. While this is necessary, it is not sufficient. Research! America and others have reported that U.S. patients identify their physicians as the most trustworthy source of information about clinical trials, and thus capable of influencing their willingness to participate. However, barriers exist to utilizing this resource at its full value. Whether practicing independently, or as employees of integrated hospital systems, the patient-physician interaction has become more tightly scheduled and complex. Few physicians are aware of clinical trials underway in their communities, and few can allot time to engage patients in the discussion of clinical trials during a routine office visit. Until it becomes a priority, significant segments of the population will be limited in their opportunities to be represented in clinical trials!
Physicians-caregivers, irrespective of whether practicing as independents or employees, should be concerned that data may be limited or nonexistent to establish the appropriateness of the drugs they use to treat their patients. However, as a principal trustworthy resource, they may be best positioned to address this limitation. Thus, Project IMPACT recognizes that achieving our mission requires us to respond to the changes in the health care environment. This requires updating our program to include raising awareness of these responsibilities with physicians and health institutions and developing ways to incentivize and facilitate physician involvement in roles other than or in addition to investigator. While we acknowledge this to be a formidable challenge, we are working collaboratively with other medical organizations and associates to develop processes and technology that limit the time and effort, and minimize the burden for every physician to contribute to inclusive clinical research.
For more information, visit http://impact.nmanet.org.
James H. Powell, M.D., is Principal Investigator, Project IMPACT.