Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The Catalyst welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view.
Today, we are pleased to welcome a guest post from Dr. Barbara Bierer, faculty director of the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center), a Professor of Medicine, Harvard Medical School and Brigham and Women’s Hospital, Boston and a hematologist/oncologist.
The COVID-19 pandemic is the worst public health emergency the world has encountered in over a century and one that has universally impacted the social, political, economic and medical fabric of our lives; it has also exposed significant and systemic health disparities in health care. The disproportionate rates of infection and of disease-related mortality of people of color have been well-documented. Given these disparities, it is critical that trials for COVID-19 vaccines and therapeutics ensure diverse participation. The few exceptions that have been reported, however, prove that recruitment and retention of underserved populations is possible with effort, planning and intentionality of purpose.
Underrepresentation of diverse participants in clinical trials is not a new phenomenon. Many barriers to equitable inclusion are known (e.g., lack of community involvement, inconvenience and expense of participation), but there has been little forward progress to date. The sobering data from the pandemic coupled with the sociopolitical events in the U.S. that exposed the degree of structural racism may lead us, finally, to a moment of reckoning, a call to action and the motivation to redress health inequalities. The objective of mitigating and eliminating health disparities starts with recognition and with health research that itself will help lead to change—but only with the inclusion of traditionally underserved and underrepresented individuals in research.
The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) is a research and policy center created to address the ethics, conduct, oversight and regulatory environment of clinical trials, with a focus on multinational trials. Three years ago, the MRCT Center identified the lack of appropriate diversity in clinical research as a pervasive problem and convened a multi-stakeholder group to address it. In August of 2020, we put forth Achieving Diversity, Inclusion, and Equity in Clinical Research that includes guidance and recommendations as well as practical tools and resources that can be deployed to enhance clinical trial diversity. While affirmative changes can be made by every representative individual and organization in the research enterprise, remediation and success will take time; that success can only be achieved by communication, cooperation, accountability and transparency. The success of each entity is dependent upon others, and we must grow comfortable having often tough conversations in the spirit of helping one another.
This week PhRMA published a strong statement embracing equity, denouncing racism and putting forth actionable commitments endorsed by its member companies. PhRMA has expanded its Principles on Conduct of Clinical Trials to emphasize and strengthen the commitment to diverse inclusion in clinical trials. The MRCT Center applauds the seriousness with which the problem of health inequities is being addressed, including the call for investments in workforce development and professional opportunities, in changes in trial design and conduct, in community engagement and partnership, in education and in infrastructure. None of these initiatives will succeed, however, unless we appreciate our interdependencies and common interests. We are all and each responsible and must stand together for change.
Learn more about these efforts at phrma.org/equity.
