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Editor’s Note: In our recent white paper, Achieving Clinical Trial Diversity: Expanding
Hospital Capacity to Offer Trials in the
Community, Manatt Health discusses the important
role of community hospitals and health systems in expanding access
to clinical trials for diverse populations in the community, shares
how to leverage hospitals’ ability to contribute to advancing
science by supporting research related to the trials, and offers
strategies to advance these efforts. Based on the guidance provided
in the paper, coauthor Donna O’Brien was invited to give a
presentation at the National Academies of Sciences, Engineering and
Medicine’s (NASEM) Forum on Drug Discovery, Development and
Translation on October 12. The presentation, summarized below,
focused on how to expand community hospital capacity to offer
clinical trials and engage with diverse populations. Manatt is
hosting a free webinar on November 2 that will provide a deep dive
into the issue of increasing community hospitals’ capacity to
support clinical trials. Click here to learn more and register. Even if you
can’t attend the live program, register now and receive a link
to view the webinar on demand.
The inclusion of racial and ethnic groups in clinical trials has
been a national priority for decades, but progress toward that end
has been limited. When the Covid-19 pandemic threw into stark
relief the underlying inequities in health care access (and thus in
access to clinical trials), Congress and the Administration were
moved to action. In parallel, trial sponsors, hospitals, and other
stakeholders have been accelerating efforts to increase diverse
populations’ access to clinical trials. Given the complexity of
the challenge, much more action is needed at multiple levels and by
all involved.
Access to clinical trials depends upon how easily a patient can
access care generally, whether providers offering the appropriate
trial for the patient are nearby, whether the patient has trust in
the physician recommending the clinical trial, and whether and at
what level the patient has health care coverage to pay for care.
These conditions often are not met, resulting, even under the best
circumstances, in the exclusion of people of color and lower-income
patients. For most people, including diverse populations, the
point-of-care is in a community hospital or their outpatient
programs or physician practices. Though there are examples of
robust clinical trial programs being offered by community
hospitals, many do not offer trials—or their capacity to do
so is limited. Examples of initiatives to expand trials in the
community to reach diverse populations include a program launched
by the National Cancer Institute in the 1980s1 and
recent efforts by pharma companies2, 3 and advocacy
groups,4 but the scale of these efforts and funding are
limited. There remains significant untapped potential for expansion
of trials in the community.
To make progress, it is crucial to understand the health care
ecosystem within which clinical trials are offered. Many
initiatives aimed at breaking down barriers to access focus on the
critical need to build trust between providers and diverse
populations in the community. Of equal importance is the need to
strengthen the overall capacity of the health care delivery system
infrastructure to support clinical trials at the point of care.
In Manatt’s recent white paper, we provide more context on the
factors that influence access to clinical trials, including
insurance coverage related barriers, and offer concrete strategies
that can be used by community hospitals and trial sponsors, which
include the pharmaceutical industry, the National Institutes of
Health (NIH), academic medical centers (AMCs) and others.
Strengthening hospital capacity to offer trials is a complex
undertaking. The engagement of hospital and health system
executives by trial sponsors and others is central, both to
enhancing strategies to engage with diverse populations and
patients and to addressing the challenges of infrastructure and the
clinical practice culture, as well as for supporting the
development of a mission and business case for expansion of
clinical trials to reach diverse populations in the community. The
figure below shows the parallel paths to be pursued.
Specific Actions for Community Hospitals and Trial
Sponsors
In Manatt’s white paper, we present two case
studies—one from an integrated delivery system and one from
the NCI Community Cancer Centers Program.5, 6 Both are
focused on building capacity with executive-level support. We
provide self-assessment questions, noted in Table 1, and recommend
these specific actions for community hospitals and trial sponsors
to consider:
Proposed Actions for Community Hospital Providers
- Assess current clinical trial activity and the supporting
infrastructure across the organization (see
Table 1, which lists assessment categories and questions). - Identify opportunities for expansion of clinical trials, based
on clinical program strengths (e.g., cancer, cardiology, neurology)
and determine the resources and actions required. - Develop a sustainable plan with a business and operational
strategy for expansion of clinical trials. - Learn more about outsourcing and partnership models to inform a
build/buy decision on research administrative services and clinical
trial operations. - Reach out to trial sponsors to discuss collaborative
opportunities and to build a business case to expand capacity and
accrual to trials. - Approach payers to propose a value strategy to support
expansion of clinical trials (e.g., grants and/or enhanced
reimbursement for patients on clinical trials), so funds can be
used, following best practices for capacity-building. - Link clinical trial outreach to hospital programs for community
outreach and engagement. - Identify opportunities to expand use of evidence-based
practices to engage with diverse populations and incorporate
culturally tailored strategies to build trust and address barriers
to accrual.
Proposed Actions for Trial Sponsors (pharma, NIH, AMCs)
- Identify high-potential but underperforming community hospital
sites for clinical trials, and work with executives to assess those
hospitals’ organizational and clinical culture barriers to
effective accrual and diverse accrual (see
Table 1). - Work with these hospitals’ executive leadership to support
development of a business case for their clinical trial
program. - Engage executives of community hospitals to develop and fund
disease-specific, best-practice-sharing hospital consortia that
serve diverse populations and to provide expertise for building or
expanding support functions. - Develop an evaluation approach for hospitals to assess the
factors that influence diverse accrual to trials to help inform
their program investment and a sustainable business case.
Only by bringing robust clinical trials to local communities and
their diverse populations—and offering them through trusted
high-quality providers—can accrual to trials be significantly
expanded, leading to improved treatments and better health for
all.
Footnotes
1. National Cancer Institute. The Community Clinical Oncology Program and the
Minority-Based Community Clinical Oncology Program: Accomplishments
in Cancer Clinical Trials. Bethesda, MD: NCI; 2011. Accessed
Aug. 3, 2023.
2. Genentech website. Public statement. Genentech launches oncology clinical trial
diversity alliance. June 23, 2021.Accessed Aug. 3,
2023.
3. PhRMA website. Press release. PhRMA joins top academic leaders to announce new
community-based initiative to enhance clinical trial diversity.
July 19, 2022. Accessed Aug. 3, 2023.
4. American Heart Association website. News release. Awardees named for $20 million project to foster
diversity in clinical trial research. May 17, 2022. Accessed
Aug. 3, 2023.
5. Kaluzny A, O’Brien D. Managing Disruptive
Change in Healthcare: Lessons from a Public-Private Partnership to
Advance Cancer Care and Research. New York, NY: Oxford
University Press; 2015.
6. Dimond EP, St Germain D, Nacpil LM, et al.
Creating a “culture of research” in a community
hospital: Strategies and tools from the National Cancer Institute
Community Cancer Centers Program. Clin Trials. 2015
Jun;12(3):246-56. doi: 10.1177/1740774515571141. Epub 2015 Feb 17.
PMID: 25691600; PMCID: PMC4420772.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
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