Clinical research is the foundation for the practice of evidence-based medicine. It is used to determine whether new drugs and treatments are safe and effective. Once approved by the FDA, the therapy becomes available for physicians to prescribe. It stands to reason that the more diverse the participants, the more confidence physicians have in study results and the benefits of the medicine to all people. The good news is that some aspects of diversity, such as age and gender, have been consistent components in clinical research. The bad news is that race and ethnicity as inclusion factors for study participants are far too often overlooked.
This challenge confronts the industry as we near the close of a decade that has witnessed an explosion in the growth of diverse populations that are disproportionately affected by chronic disease. Because of underrepresentation of people of color, researchers extrapolate trial data from white study participants and apply them to people of color. This could be dangerous now that there is scientific evidence that certain drugs have different effects on different ethnic groups which could affect adherence, outcomes and even the patient’s survival.
Racial and ethnic groups appear to participate in clinical trials to varying degrees. Blacks participated in trials to the greatest extent; however, their participation steadily declined from 12% in 1995 to 6% in 1999. In all cases, Hispanics appear to be far below their representation in the population (Source: CDER). The NIH Revitalization Act of 1993 requires that federally funded trials include minorities in numbers adequate to allow for valid analyses of differences in intervention effect. The FDA Modernization Act of 1997 requires standardization of data collection on racial and ethnic groups.
The barriers to participation of people of color in clinical trials are formidable but surmountable. It’s time for the industry to develop inclusive protocols and culturally appropriate strategies to recruit and retain diverse patients for clinical research. Clinical teams and investigative sites need ongoing cross-cultural education and training to support successful recruitment and retention of diverse trial participants.
Increasing diversity in clinical trials and race-specific trials are research imperatives in a marketplace growing more diverse at a much faster rate than many had predicted. Diversity in clinical research is good medicine. It’s good business. It’s the right thing to do to ensure the delivery of quality, patient-centered care in a multicultural society.
Sheila Thorne is president and CEO, Multicultural Healthcare Marketing Group
From the November 01, 2010 Issue of MM+M - Medical Marketing and Media
