The lack of racial and ethnic balance in clinical trials of pharmaceutical and biotechnology products is a well-documented cause for concern. Racial and ethnic minorities are the fastest growing segment of the American population but are often poorly represented in clinical trials.  This has led to questions regarding the ability to broadly apply the information gained in many clinical drug trials to multicultural American patients who consume the products. -Dr. James Powell

Poor participation in clinical trials limits the ability to evaluate and provide information on proper use of medical innovations for a population growing in its diversity. Without appropriate representation in clinical trials, multicultural American patients will consume products that may add to adverse outcomes resulting from the therapy, combined with the natural consequence of untreated or poorly treated disease.  Eventually, third party payers will begin to demand evidence of safety and effectiveness in the specific population of patients being treated. Heightened interest by regulators in the diversity of clinical trial representation may result in restrictive legislation. Sponsors may pursue hard and fixed requirements for specific population representation in clinical trials in the absence of culturally and linguistically appropriate strategies to engage the “minority” population of patients in discussion of the research process.

Strategic Medical Associates (SMA) is currently negotiating the involvement of physicians who provide care for ethnically diverse populations in upcoming trials of therapies for diabetes, asthma, HIV/AIDS, hypertension, stroke, and in trials for biosimilar products.

A major reason for poor minority patient participation is mistrust of the process and poor participation by their physicians. SMA introduces alternatives for providing significant patient care benefits combined with revenue generating potential to support medical practice viability in our neighborhoods through various levels of involvement in clinical research. SMA’s ACTTION Plan (Alliance for Community Trial Trustworthiness In Our Neighborhoods) is a comprehensive, ethical, community based approach to the conduct of ethnically balanced clinical trials. This process provides opportunities, training, and support for the clinical research interests and efforts of community physicians who enjoy the trust of a diverse patient population. For those physicians who may not have the time or interest to be investigators, the ACTTION Plan provides opportunities for them to contribute to the clinical research process and be compensated for their efforts.

The ACTTION Plan integrates community awareness, professional skills and technical support to achieve ethnic balance. Minority community physicians and consumers become important contributors and develop a sense of ownership in the effort to find innovative and better therapies to address their own needs as well as the needs of others. The program includes: Physician-investigator training, resourcing, placement and mentoring community physician participation in networks for clinical trial support delivery of health, disease, and clinical trial education to patients, consumers, and community influencers Physician and community input into clinical trial design and cultural appropriateness