The Center for the Study of Drug Development at Tufts University School of Medicine recently published a call to address challenges with the well-known problem of lack of diverse participation in the clinical trials process. Participation rates (not to mention referrals from physicians) is notably low among African American and African populations in America, as one prominent example. In response, well-known, non-profit CISCRP will launch a new consortium to address this known problem.
Non-profit organization CISCRP has organized a consortium to improve patient diversity in clinical trials. By partnering with ten biopharmaceutical companies and clinical research providers, they will direct energy and resources on “community-based education” over the next five years, starting in early 2020.
Who are the CISCRP Consortium Members?
Merck, IQVIA, Biogen, Otsuka, CSL Behring, Janssen, WCG, Boston Scientific, EMD Serono, and Pfizer
What will the Operating Model of this group look like?
Each participating member will have representatives who will participate on a “Steering Committee” and will offer up staff and resources to support the planning and execution of live educational events in five targeted urban centers annually.
What are some Comments on this Approach?
Jonathan Jackson, PhD, study volunteer and the Center Director of Community Access, Recruitment, and Engagement (CARE) Research Center at Massachusetts General Harvard, Harvard Medical School, notes, “This centralized approach is vital to bring together the necessary oversight and infrastructure required to engage communities around the country.”
Is there a Precedent for this Approach?
According to the press release, the Consortium initiative builds on CISCRP’s 18-year experience producing and hosting internationally recognized live educational events—called AWARE-for-ALL programs—throughout the United States and parts of Europe. Each event engages a local planning committee comprised of members of the public, patients, advocacy groups, health care and clinical research professionals, and offers educational presentations and discussions as well as free health screenings and information about local clinical trial activity. The consortium plans to mobilize pop-up educational exhibits in targeted urban health centers to generate excitement and awareness in the weeks leading up to each event.
Ellyn Getz, Associate Director of Development & Community Engagement for CISCRP, calls the initiative “important and novel” and calls out participants, saying that this “presents an unprecedented opportunity to have an even greater impact on advancing public and patient clinical research literacy over a 5-year time period with ongoing continuous improvement.”
Critical Comments and Challenges
First, the CISCRP intentions are timely and noble, and, collectively, the organization’s principals have deep experience, expertise and associated wisdom in the sphere of clinical trials. There is formidable, intellectual, professional, and practical experience behind their organizing group—it will certainly not be an academic affair based on theory. Moreover, the participating members from the industry sponsors and providers certainly have the best intentions and will work with their organizations to ensure their companies allocate time, resources, and hopefully some capital to address this fundamental challenge set.
This challenge has been ongoing for decades—despite all the work that those closely associated with the industry do on an ongoing basis. It is critically important that there is NOT a one time, centralized, top-down approach to the events, education and dissemination of information—but a facilitation of a series of community-driven, “whole person care”-focused, sustained effort that factors in clinical research as part of a broader health care imperative for empowerment and improvement for members in targeted communities—more on that later.
The appropriate buy-in direct from community members and their networks is of paramount importance for the critical trust-building process.
Why is this important?
Well, first and foremost, as we have discussed based on our decades of knowledge and even a recent survey in southeast Texas, there is little trust in industry sponsors, government, and for that matter, major health systems unless there is a well-conceived, systematic and continuous presence in the communities that lack such trust. Trust is built over time with consistent actions and ongoing engagement that evidence results.
One problem with the one-time event model is that they can be perceived by community members as here today and gone tomorrow. The transfer of information, although important, doesn’t by itself ensure the prerequisite building of trust. Surely, a well-thought out community participation in targeted events can help introduce awareness but it alone won’t solve the fundamental problem we all know exists.
And how do we know? Because industry sponsors, academic centers, and even the federal government, via the NIH and its divisions, have been undertaking such events for many years—with what is arguably failed results, when we measure the totality of results over the past two decades. The percentages of minority groups participating in clinical trials, for example, hasn’t noticeably improved yet lots of money was spent trying. The chasm between the healthy and unhealthy grows—and this is manifested in who participates in clinical research. Clinical research participation seriously lacks diversity.
Some Consideration to A New Paradigm
We believe we have arrived at a real health crisis—especially when we factor in social determinants of health and how we can correlate severe health degradation by just a zip code.
We have some knowledge of this subject, having structured some leading “whole person care” community-based care coordination initiatives around the country. Moreover, a couple of our principals were involved with major patient recruitment initiatives two decades ago—the same challenges with minority community engagement occurred back then—in some cases, the problem is worse today due to overall degradation of general health conditions in certain socio-economic demographic segments—even with countless millions spent on education and ongoing outreach.
Sustained Localized, Community-Owned and Driven Networks
Localized social networks must be identified in targeted locations—these networks must be somehow supported and encouraged to engage and sustain for lengthier periods of time. Trust, empathy, and engagement must be fostered in an organic and authentic manner. Healthcare sector participants (payer, provider and sponsor) must become vested into the local community as well as engaged in a sustained and material way.
Examples of engagement across the United States are available—from payer to provider-originated initiative—that we believe could represent a foundation for work in building advocacy and awareness for greater clinical research participation. The move to value-driven care and various experimental models via HHS Medicaid waivers reveals some interesting examples of creative, community-driven responses to improve health care conditions. We know of one such group in Houston completely organized by community providers from the ground up to solve shared social determinant of health-driven challenges in communities across their vast city.
More than One Time Events or Episodic Touch Points
Marginalized communities need not one-time episodic touchpoints based on a specific clinical program or a one-time initiative but rather, an ongoing community-centric investment that results in empowered and enlightened healthcare consumers. There have been many hundreds of examples of sponsor or industry-driven outreach campaigns over the past decades. On the margin, they undoubtedly had positive influence for many, but the actual clinical trial participation data evidence has failed to hit its targets.
A Whole-Person-Care Movement
Purpose-driven combinations of local health systems, payers, sponsors and community-based organizations can result in tremendous improvements in clinical research education, awareness, and participation. Based on this, it will take forward-thinking individuals and organizations to take the lead. A more powerful theme, such as the Triple Aim of health care, must underscore and help drive the momentum towards greater individual and community outcomes and lower overall costs to payers with clinical research as a powerful health care option where and when appropriate
Where trust is in deficient supply, intensive community-based involvement—including empowered seats at the leadership and planning tables—constitutes a irrefutable prerequisite for success. The participation in clinical research represents an important constituent element of a whole-person-care paradigm shift, leading to measurable results.