How to reduce racial disparities in cancer

Underrepresentation of racial minorities in clinical trials for cancer and other diseases isn’t new; there has been a significant dearth in the representation of minorities in oncology trials for years.

There is a strong consensus among all key stakeholders about the importance of addressing the problem of inadequate representation of minority patients in clinical trials and an urgent desire to develop sustainable solutions, as demonstrated at a recent American Association for Cancer Research (AACR) meeting. Participants included leaders from across the cancer ecosystem: patient organizations, industry, government, researchers, academic medical centers and community-based organizations.

Between 1999 and 2019, the percentage of underrepresented groups in National Cancer Institute (NCI) clinical trials increased from 14 percent to 25 percent, according to Dr. Douglas Lowy, NCI principal deputy director. “There is a still a lot of room for improvement,” he noted. Indeed, evidence shows the need for very significant improvement, particularly in cancer trials. Pfizer found that from 2011 to 2020, only 15.8 percent of its oncology trials had a patient population at or above census for Black or African American patients.

But trials are only part of the story. Disparities also exist in access to new therapies. As promising new treatments like immunotherapies come to market, these treatments must be made available for all patients in all communities as quickly as possible.

Certainly, any research group can improve the participation of minorities in a single trial by throwing enough money and resources at the problem. But this is not a sustainable, scalable solution. Individual players acting alone can’t effect meaningful change over the long-term. What is needed is collective impact created by multiple stakeholders.

The key to achieving this collective impact is forming powerful new partnerships — new coalitions of stakeholders — aligned around common goals, metrics and activities. Such coalitions can create the critical mass to truly move the needle.

There are several relevant precedents in health care involving transformative public-private partnerships (PPPs). For example, the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) is a partnership led by the National Institutes of Health (NIH) and coordinated by the Foundation for the NIH (FNIH).

ACTIV’s goal has been to develop a research strategy for prioritizing and speeding development of the most promising COVID-19 vaccines and treatments during the pandemic. To do so, ACTIV brought together other government entities, including the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Department of Defense , the Biomedical Advanced Research and Development Authority , the Veterans Administration, as well as scientists from industry, academia and philanthropy. Of note, the FNIH played a constructive role in minority (or “equitable”) patient recruitment for SARS-CoV-2 vaccine trials.

Lessons from COVID-19 and ACTIV and the critical need for a central coordinating role such as that played by the FNIH in ACTIV are highly relevant to attempts at reducing disparities in cancer trials. For example, creating a database with information about the patient demographics and organizational capabilities of different cancer trial sites could help researchers make site-selection decisions that yield more representative patient populations. Specific funding could help community-based sites with large numbers of minority patients develop the infrastructure and capabilities to participate in trials.

Another lesson from the ACTIV success is that collective impact requires a backbone organization to coordinate the initiative, as the FNIH did in supporting ACTIV’s efforts to accelerate COVID drug development.

According to David Wholley, interim president and executive director of the FNIH, a public-private partnership would need to be able to affirmatively answer several critical questions to be successful: Does the PPP address a significant unmet need? Is the most appropriate solution to this need something that is not already being done effectively elsewhere, and is it something uniquely suited to a partnership rather than single entities? Is there a clear value proposition for all partners? Is there leadership and executive sponsorship from the top? Ideally, a successful partnership should also leverage currently available (or planned) efforts and resources. Could a partnership to reduce disparities in cancer research, for example, take appropriate advantage of NIH’s current priorities and resources in this area?

We believe that a public-private partnership focused on reducing disparities in cancer research is not only entirely feasible but fulfills these criteria particularly well. Moreover, we believe that involvement of a third-party organization like the FNIH would be critical to providing the essential backbone needed to build, guide and coordinate such a PPP. Such an organization would need to have demonstrated the experience, credibility, leadership and contacts required to bring together the resources and expertise from government, industry, academic and patient groups that will be needed to address such a complex, large-scale challenge.

As part of the 21st Century Cures Act passed in December 2016, $1.8 billion was authorized for the Cancer Moonshot. We envision that a partnership focused on reducing disparities in cancer trials and improving access to breakthrough treatments could potentially be partially funded by the recently reinvigorated Cancer Moonshot, in addition to funds provided by industry partners, advocacy groups and philanthropy. We think it should be a priority for the Cancer Moonshot to play a leadership role in such a broad-based public-private initiative.

Ultimately, forming an effective public-private partnership will require collaboration and support across the entire ecosystem. Also, rather than relying on short-term commitments, any long-term success at eradicating racial disparities must be founded on a sustainable model, which will require ongoing commitment, leadership, funding and participation.

Having experienced a lack of proportional representation of minority patients in oncology trials for years, now is the time to urgently work together to solve this problem. Saving lives lost to cancer is neither a “red state” nor “blue state” issue: Ultimately, cancer respects no racial or political boundaries. It is our hope that providing adequate funding and resources for a public-private partnership that improves access to trials and treatments for all will be both bipartisan and enduring.

Kathy Giusti is founder of the Multiple Myeloma Research Foundation and co-chair of the Harvard Business School Kraft Precision Medicine Accelerator.

John Carpten is professor and chair of Translational Genomics at the Keck School of Medicine at the University of Southern California.