Clinical Trial Disparities: A Case for Diversity

November 19, 2009
Robert A. Beltran, MD, MBA, Chairman EDICT Publications Team

,
Susan S. Night, JD, LLM, PhD(c), Intercultural Cancer Council

,
EDICT Postdoctoral Fellow

,
Armin Weinberg, PhD, Professor and Director,

The challenge of eliminating disparities in clinical trials is being addressed by the Eliminating Disparities in Clinical Trials (EDICT) project, which recognizes that broadening diversity in clinical trials will result in improved effectiveness and safety of future medicines, improved trial quality, and reduced discrepancies in health equity.

We reap what we sow. The United State has invested heavily in its healthcare system which produces many wonderful outcomes such as cutting edge medical technology and innovative clinical research. However, there is wide variation in access to healthcare services and the quality of care that is provided to many of the diverse populations in this country. This variability of clinical effectiveness and quality is identified as health disparities.

There are significant disparities in the way healthcare is accessed, utilized and delivered in the United States. Health disparities occur to such a degree that they have become one of the most visible flaws in the fabric of our American healthcare system.

Studies have documented the fact that low-income Americans along with racial and ethnic minorities experience disproportionately higher rates of disease, fewer treatment options, and reduced access to care. Now that unemployment is on the rise, disparities already apparent among these groups will only continue to increase.

At the same time, the US healthcare system is globally recognized for its quality of medical care. Who can argue with a healthcare system that seeks to achieve and advance medical excellence? The overall benefit of such a system would be higher quality, lower cost, better coordination, and improved patient compliance and satisfaction at the very least. The outcome for our current and future healthcare needs would translate into increased accountability, improved societal health and well-being and ultimately less burden of disease.

Common sense dictates that healthcare policies and resources must focus on eliminating disparities in healthcare if we seek to achieve medicalexcellence. These disparities extend beyond healthcare. They also persist in the realm of clinical research and access to clinical trials. The vast majority of clinical trial participants are income neutral, male and Caucasian, even though federal policy requires inclusion of women and minorities. The challenge of eliminating disparities in clinical trials is being addressed by a national team of experts leading a project titled “Eliminating Disparities in Clinical Trials” or EDICT. The EDICT project

is funded by an unrestricted grant from Genentech, Inc. and headquartered at Baylor College of Medicine.

The concerns over disparities in clinical trials include the potential for decreased clinical effectiveness, lower clinical trial quality and lack of health equity. Clinical effectiveness is compromised when the participant population enrolled in a clinical trial does not have an appropriate relationship to the population burdened by the disease under study. In this situation, the ability to generalize trial results across the population targeted for the intervention becomes suspect. The inability to apply clinical trial results to a larger, more diverse population ultimately impacts the overall quality of the clinical trial.

The lack of diversity in the participants of clinical trials also contributes to an ongoing and increasing discrepancy in health equity. Three principles as outlined by the Commission on Social Determinants of Health

must be utilized to enhance health equity (a) improve the circumstances in which people are born, live, work, and age; (b) tackle the inequitable distribution of power, money, and resources - structural drivers of conditions of daily life - globally, nationally and locally; and (c) measure the problem, evaluate action, and expand the knowledge base.

In the quest toward eliminating disparities in clinical trials, the challenge remains, as Hammarskjold suggests, in staying committed to the pursuit of progress. Above all, the goal of equal access, equal treatment and equal opportunity is one that should "never be relaxed and never abandoned."

We have a window of opportunity through current healthcare reform initiatives to enhance the diversity of participants in clinical trials. Broadening the diversity in clinical trials will result in improved effectiveness and safety of future medicines. Clinicians and researchers have a responsibility to support the need and benefit of greater diversity in clinical practice and study design. Whereas policymakers must step up with resources that enable action and require accountability.