6

Challenging the Clinical Trial Ecosystem

Panelists representing patients, industry, public–private partnerships, and government discussed practical and implementable collaborative approaches for advancing more equitable and representative participation in clinical trials, including to scale and sustain diverse and inclusive trials and improve public awareness about participation. The discussion was moderated by Michelle McMurry-Heath, founder and CEO of BioTechquity Clinical.

A PATIENT PERSPECTIVE ON TRUST AND ACCESS

Gwen Darien, executive vice president of patient advocacy, engagement, and education at the Patient Advocate Foundation and member of the National Cancer Policy Forum, said there are “many patient advocates who are working toward equity and inclusion in clinical trials,” and their voices are often missing from these discussions, including at the workshop. Darien is herself a three-time cancer survivor and believes her second and third cancers were an effect of late treatment of the first. She mentioned a publication on unconscious bias she and fellow advocate and cancer patient, the late Mary Jackson Scroggins, authored nearly 2 decades ago; they discussed how Black patients were willing to participate in clinical trials, sometimes at rates higher than their White counterparts, but were not asked to do so by their clinicians. She observed that “we haven’t really moved very far” and that conversations about diversity in clinical trials have been going on for a long time.

Darien noted that trust was a theme throughout the workshop. Discussions about trust are very often about increasing patient trust in health care and clinical research, but she called for more discussion about increasing physician trust in patients. Very little has been published on this in the scientific literature, though Darien referred participants to a paper she coauthored (see Grob et al., 2019). She suggested that change will not be possible without that mutual trust.

Access to clinical trials was another theme. As an example, Darien shared a discussion with a colleague running a multiple myeloma trial. Black patients have a higher mortality rate than White patients, yet when Black and White patients are given the same treatment, Black patients respond better. The disproportionate mortality rate is associated with lack of access to the treatments. Darien also pointed out that attention is needed on what happens after the trial is completed, as many patients do not have access to the treatments that result from clinical trials.

In response to a question about return on investment for a patient participating in a clinical trial, Darien said people typically believe they will benefit from it and the resulting discoveries. However, “there is no return on investment to patients if we don’t have equity in our health delivery

system,” she said. The goal should be not just diverse enrollment in clinical trials but “equitable health for everyone.” Moses said additional perspectives that would have been helpful for these discussions include actuaries and economists who could speak to return on investment for clinical trial participants and the participants themselves.

IMPLEMENTING FDA AUTHORITIES AND MANDATES

Mary Thanh Hai, deputy director for clinical science in the Office of New Drugs (OND) at the Center for Drug Evaluation and Research (CDER), said that “enhancing diversity and inclusion in clinical trials is a top priority” for the agency. She provided additional information on some of the U.S. Food and Drug Administration (FDA) activities mentioned during the workshop. One is the publication of a range of guidance documents, including on improving clinical trial diversity relative to demographic and nondemographic characteristics¹ and guidance on innovative trial designs.² Another is implementing provisions required under the Food and Drug Administration Modernization Act, Food and Drug Administration Safety and Innovation Act (FDASIA), and Food and Drug Omnibus Reform Act (FDORA).

Thanh Hai elaborated on the diversity action plans and Drug Trials Snapshots mentioned by FDA Commissioner Califf. “Section 3601 of FDORA amended the Food, Drug, and Cosmetic Act to require diversity action plans … for certain studies,” she said. The draft guidance was forthcoming at the time of the workshop, with the requirement set to go into effects 180 days after the final guidance is published. In April 2022, before FDORA, Thanh Hai said FDA issued a draft guidance on Diversity Plans to Improve Enrollment of Underrepresented Racial and Ethnic Populations in Clinical Trials.³ FDA received an increasing number of diversity plans submitted voluntarily in response, which she said is encouraging because it shows that industry and other involved parties are engaged in improving diversity in clinical trials even before it is mandated. Thanh Hai also confirmed that “diversity action plans are here to stay; it’s a statutory

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¹ The FDA draft guidance, Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies (FDA, 2024b), was released for comment after the workshop, on June 26, 2024. See https://www.fda.gov/media/179593/download (accessed September 9, 2024).

² Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products (FDA, 2020). See https://www.fda.gov/media/130897/download (accessed September 9, 2024).

³ Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry (FDA, 2022). See https://www.fda.gov/media/157635/download (accessed September 9, 2024).

requirement.” Plans will need to be submitted no later than the Phase 3 study protocol. She anticipates more plans submitted after the statutory requirement goes into effect, although the exact number of Diversity Action Plans received will depend on the number of drugs that reach Phase 3 trials. That said, approximately 250 plans have already been submitted voluntarily by sponsors to CDER even before their statutory requirement goes into effect. Thanh Hai noted this is an encouraging trend.

Thanh Hai emphasized that diverse enrollment in clinical trials should be planned for prospectively, from the start of drug development and as early as the concept phase. This involves developing an understanding of the epidemiology of the disease. Sponsors should engage FDA, global regulatory agencies as appropriate, patients, and other relevant organizations.

Rodriguez-Watson recalled the discussions throughout the workshop on the need for standardized data collection and for tools such as sets of minimum data elements to enable data sharing. She pondered whether these could be incorporated into rulemaking. For example, could the diversity action plans “reference the need to have these data submitted through standardized methods” to better facilitate data analyses for regulatory and coverage decision making?

The Drug Trials Snapshots transparency initiative was implemented “in response to a requirement under Section 907 of FDASIA,” Thanh Hai said. A snapshot is available for all approved new molecular entities and describes participant demographics and, to the extent possible, the benefits and risks of the product by race, ethnicity, sex, and age. FDA also releases an annual Drug Trials Snapshot Summary Report. The 2023 summary covers 55 new drug approvals. Thanh Hai noted that for 2023, data on percentage of participants from U.S. study sites is also included.⁴ Importantly, she said, data are presented for each drug individually, not in aggregate, to facilitate comparative analysis across products.

Thanh Hai referred participants to the CDER Center for Clinical Trial Innovation for more information about innovative designs that could help improve representation in clinical trials (e.g., decentralized trials, pragmatic trials, point-of-care trials, use of digital health).⁵

PUBLIC–PRIVATE PARTNERSHIPS

Stacey Adam, vice president for science partnerships at the Foundation for the National Institutes of Health (FNIH), explained that it is a nonprofit organization established in 1990 by Congress to facilitate public–private

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⁴ Also discussed by Califf in Chapter 5.

⁵ See https://www.fda.gov/about-fda/cder-center-clinical-trial-innovation-c3ti/about-cder-center-clinical-trial-innovation-c3ti (accessed September 9, 2024).

partnerships with the National Institutes of Health (NIH). Addressing the challenge of increasing diversity in clinical trials can involve bringing all key collaborators and sectors to the table. Its new motto is “building bridges to breakthroughs,” and Adam mentioned several ongoing NIH activities that FNIH is involved in to provide examples of how to “leverage partnerships in their most creative ways, in their most diverse ways, to really address some of the challenges” discussed during the workshop.

NIH will be launching a network for point-of-care or primary care clinical trials, and Adam referred participants to the Research Opportunity Announcement about this project.⁶ FNIH is also working with NIH director Bertagnolli to increase data interoperability both within NIH and more broadly. Efforts are also underway to bring partners together from across government organizations to leverage the lessons learned from COVID-19 clinical trials. For example, community engagement in research during the pandemic was hampered by the lack of pre-established relationships. In response, FNIH worked with NIH to put together clinical trial networks to share data, which also provided insight into best practices for engaging communities quickly, particularly in areas that didn’t not have pre-established relationships.

Adam said FNIH is looking to “leverage everyone in the ecosystem to really provide solutions that couldn’t be provided otherwise.” FNIH is now focused on engaging patients with lived experience across all its partnerships, be it translational research or clinical trials. Furthermore, FNIH is striving to bring diversity, equity, inclusion, and access into all its partnerships. This entails having both study populations and investigators that are representative of the populations impacted by the disease or condition under study.

SPONSORS BUILDING COMMUNITY CAPACITY

Mary Nwokedi-Nwaneri, director of diversity in clinical trials at Pharmaceutical Research and Manufacturers of America (PhRMA), said its equity activities are built on three pillars: health equity (focusing on health systems management), increasing diverse talent, and increasing diversity in clinical trials. A key initiative of the clinical trials pillar is the Equitable Breakthroughs in Medicine Development (EQBMED) program (discussed in Chapter 4) to build the capacity of community-based sites to conduct diverse clinical trials. The program is being led by Yale University,⁷ in collaboration with Morehouse School of Medicine and Vanderbilt University,

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⁶ See https://commonfund.nih.gov/clinical-research-primary-care/Primary-care-research-network-Research-Opportunity-Announcement-FY24 (accessed September 9, 2024)

⁷ Also discussed by Nwanyanwu in Chapter 4.

with a $10 million grant from PhRMA. The initiative will address operational capacity and community engagement with sites by identifying and addressing specific barriers, including ways to connect the community to developing sites. The program is in the pilot phase with 16 community partners. The goal is to scale nationally through “cross-ecosystem collaboration” between product sponsors and other organizations, she said.

Nwokedi-Nwaneri shared that she recently visited a newly enrolled EQBMED site. One thing that stood out was that the site had collaborations with many different sponsor companies. This is an example of EQBMED trying to “maximize cross-collaboration of investments at these different sites that [are] already engaging with underrepresented communities in order to really maximize the effect of these different investments… to ensure that we’re moving toward more of an infrastructure support or a foundation support to access individuals of color and meet them where they are within their communities.”

DIVERSITY IN DEVICE CLINICAL TRIALS

DeChane Dorsey, executive director of AdvaMed Accel, the small company division of AdvaMed, discussed how the medical device trade association is working to improve health equity, including increasing diversity in device trials. AdvaMed’s health equity activities are built on four principles.

The first is reducing and eliminating bias in the provision of health care. Dorsey said this “significantly impacts how patients seek out care and the quality of care.”

The second is raising patient awareness about available devices for treating their condition. All patients should receive the same type of information about treatment options in formats they can comprehend, such as plain language summaries in multiple languages. It is also important for the caregivers to be fully informed, if applicable. Obeying this principle may involve improving cultural competency among clinicians to avoid assumptions about what a given patient can afford or would be willing to try.

The third is improving access to the most appropriate care, regardless of insurance coverage. Dorsey pointed out that digital technologies have a “huge possibility of enabling patients in areas where there are specialty deserts or clinical deserts to get care they might not otherwise be able to access.” Because many of these new technologies require broadband and Internet access, Dorsey considers connectivity equity as an element of access to new devices. AdvaMed is working with external groups to support legislation and other initiatives to advance that infrastructure.

The last principle is improving diversity in clinical trials, among both participants and the investigators and researchers conducting the trials. Dorsey noted that patients share their experiences from device trials with

others in their communities, which can provide reassurance to others regarding accessing health care and using these technologies.

THE ROLE OF CMS COVERAGE IN HEALTH EQUITY

Natalia Chalmers, chief dental officer at Centers for Medicare & Medicaid Services (CMS), said the agency’s vision is “to serve the public as a trusted partner, to advance health equity, improve access, and improve clinical outcomes,” and she emphasized that “advancing equity is in the heart of everything we do.” CMS provides health coverage to 156 million people, or one in two individuals. This includes about 67 and 86 million Medicare and Medicaid beneficiaries, respectively, about half of whom are children.⁸ Medicaid and Medicare program expenditures are more than $1.7 trillion and account for 40 percent of health care spending.⁹ In 2022, CMS spent $22,000 per person aged 65+. CMS spends about $4,000 per year for children and about $9,000 per year for working-age adults. When assessing whether to cover a new product, CMS considers how much it improves outcomes and closes health equity gaps. Chalmers noted that Congress plays a “critical role” in deciding what is covered and who is paid.

Medicare is a federal program, but each state runs its own Medicaid program in accordance with federal guidelines. In addition to these programs, 21 million people currently obtain coverage through the health care marketplace.¹⁰ Overall, 44 percent of children and 23 percent of adults have public insurance.¹¹ This varies by race and ethnicity. For example, 65 percent of American Indian and Alaska Native children and 60 percent of Hispanic children are covered by Medicaid.¹² In addition, Chalmers said that “Medicaid covers 41 percent of all births in the United States,” and therefore clinical trials enrolling pregnant persons would likely include participants who have public insurance.¹³ Similarly, over 60 percent of children

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⁸ As of November 2023 (CMS, 2024b), see https://content.govdelivery.com/accounts/USCMSMEDICAID/bulletins/38df7c8 (accessed September 9, 2024).

⁹ National Healthcare Expenditures for 2022 (CMS, 2024c), see https://www.cms.gov/data-research/statistics-trends-and-reports/national-health-expenditure-data/nhe-fact-sheet (accessed September 9, 2024).

¹⁰ As of January 2024 (CMS, 2024a), see https://www.cms.gov/newsroom/press-releases/historic-213-million-people-choose-aca-marketplace-coverage (accessed September 9, 2024).

¹¹ For 2023 (CDC, 2024), see https://cdc.gov/nchs/fastats/health-insurance.htm (accessed September 9, 2024).

¹² For 2020–2022 (March of Dimes PeriStats 2024), see https://www.marchofdimes.org/peristats/data?reg=99&top=11&stop=653&lev=1&slev=1&obj=1 (accessed September 9, 2024).

¹³ As of 2021 (CDC, 2023), see https://www.cdc.gov/nchs/products/databriefs/db468.htm (accessed September 9, 2024).

in some states are covered by Medicaid, so it is important for a clinical study looking to enroll pediatric populations to understand the program.¹⁴

Chalmers elaborated on two provisions that enable clinical trial participation for Medicaid and Medicare beneficiaries. Per Section 210 of the Consolidated Appropriations Act,¹⁵ as of January 1, 2022, Medicaid agencies are required to cover routine costs for participation in a qualifying clinical trial, including “any item of service provided to prevent, diagnose, monitor, or treat complications resulting from the clinical trial,” she said. This is an important change for people who might otherwise not be able to afford the costs of trial participation.

Medicare Coverage with Evidence Development (CED) provides coverage for items and services provided during participation in a qualified clinical study even if “evidence is insufficient” to support a national coverage, Chalmers said. This is important, she explained, because it allows Medicare beneficiaries to have early access to new treatments. She referred participants to the draft guidance on proposed CED.¹⁶ It discusses the appropriate diversity of study populations relative to “race, ethnicity, gender, age, disabilities, important comorbidities, and relevant social determinants of health,” she said. To illustrate the importance of including patients with comorbidities in CED studies, Chalmers said that of Medicare beneficiaries with diabetes, 97 percent have one or more comorbid conditions, 41 percent have five or more, and only 3 percent have none. If clinical trials do not include sufficient representation of people with similar patterns of comorbidities, she said, the findings may require additional evidence development. McMurry-Heath noted that many FDA-approved trials do not meet those criteria, to which Chalmers responded that a team of CMS experts “looks at all the existing evidence of current therapies, all the new evidence and benefits, and makes that determination.”

MAKING THE BUSINESS CASE FOR DIVERSITY IN TRIALS

During the discussion, panelists considered some of the challenges for product sponsors in meeting federal agency expectations for diversity and inclusion in clinical trials. Dorsey noted a “culture of competitiveness,” and that sponsors may have concerns that their trials will be delayed due to the extra time it will take to identify and enroll a more diverse population. This extra time and effort can be a particular concern for smaller companies with limited capital. Dorsey reiterated Currie’s point about the

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¹⁴ In 2022 (KFF, 2024), see https://www.kff.org/interactive/medicaid-state-fact-sheets/ (accessed September 9, 2024).

¹⁵ Also discussed by Ling in Chapter 5. Pub. L. No. 116–260, § 210.

¹⁶ Also discussed by Ling in Chapter 5. See CMS, 2023.

need to make the business case for diversity in clinical trials. AdvaMed is focusing its messaging less on the moral imperative for representative trials and more on the business case for developing products that more patients will want to use. She noted, “A better-informed and better-developed product … gets to a larger segment of your potential patient market.” She also shared a concern that conversations about health equity in the clinical trials space can overlook medical devices in favor of drug development.

AdvaMed is working with CMS and FDA to get more clarity around anti-kickback statutes and the Stark Law. Dorsey noted a lot of misunderstanding around what can legally be done to help patients enroll and remain in clinical trials (e.g., transportation or daycare, evening and weekend hours for appointments). Sponsors want to understand how they will be protected from accusations of inducing participation. She said, “As the legislators and lawmakers deal with these issues, it’ll be really important to create some clarity around some of these areas so that industry is able to proceed more effectively in making these changes.”

Adam said FNIH has also heard sponsor concerns about “lack of speed.” She said government clinical trial networks run deep, often deeper than private sector networks. NIH has relationships with numerous community sites, such as the National Cancer Institute National Clinical Trials Network (NCTN).¹⁷ “We are starting to prove to people that we are trustworthy,” she said, and public–private partnership on clinical trials can enable diverse enrollment. She acknowledged that companies do give up some level of control in partnering, but recruitment will overall be faster. One example is the NCTN Lung Cancer Master Protocol (Lung-MAP) for a non-small-cell lung cancer trial, which encompasses over 700 sites across the United States;¹⁸ 17 companies have partnered with it, and, while not all companies were able to find the correct patient population through the program, they obtained the data faster than they could have on their own.

Coylewright said sponsors often tell her they want to include more diverse populations but add “because they have more comorbidities, the complications and outcomes are worse,” and then the product “won’t be competitive in the market.” She suggested it would be helpful to have a set of talking points that could be used to respond to questions about why improving diversity in clinical trials is necessary, especially key points for making the business case.

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¹⁷ See https://www.cancer.gov/research/infrastructure/clinical-trials/nctn (accessed September 9, 2024).

¹⁸ See https://www.cancer.gov/types/lung/research/lung-map (accessed September 9, 2024).

TRAINING CLINICAL INVESTIGATORS AND TRIAL STAFF

As the number of sites enabled to conduct clinical trials expands, more clinicians will need to be trained as clinical trial investigators. Thanh Hai explained that “it is the sponsor’s responsibility to select the investigators and the clinical sites,” not FDA’s. An institutional review board oversees that process and ensures that investigators have the necessary training and expertise to execute the trial protocol.

A critical element of the investigator’s role is collecting quality data to support regulatory decision making, Thanh Hai said. As more clinical trials include locations outside of major academic medical centers, more nontraditional investigators and novel trial designs will be involved. Thanh Hai said FDA is very supportive of this and has issued guidance documents on collecting quality data for regulatory submission. As examples, she mentioned the FDA draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices,¹⁹ and final guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.²⁰ FDA supports investigator training through engagement activities. Thanh Hai noted that she has met with fellows at Morehouse College of Medicine and at Stanford to discuss FDORA and diversity action plans. Changing the clinical research enterprise will take time and training, but, she said, “it’s an effort that’s well worth it.”

Chalmers emphasized that becoming a qualified clinical investigator requires additional training beyond the standard medical school curriculum. She agreed that collecting quality data to inform benefit–risk decisions is essential, and clinicians who want to be investigators should be trained in the responsible conduct of a trial and collection of quality data. She added that this training, which is the “responsibility of the sponsor,” needs to be an integral and ongoing part of the clinician’s work. It is not a one-time event or something to be squeezed into a free evening. Also important is having investigators who can “communicate to the patients in a culturally competent way, what are the risks, what are the benefits,” she said. Investigators should also understand “that what they do has impact on millions of people down the road.” From a CMS perspective, for example, Chalmers said a product could be covered for over 66 million beneficiaries if investigators collect quality, standardized primary data for CMS safety and efficacy analysis.

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¹⁹ Conducting Clinical Trials With Decentralized Elements Guidance for Industry, Investigators, and Other Stakeholders (FDA, 2024c) See https://www.fda.gov/media/167696/download (accessed September 9, 2024).

²⁰ Digital Health Technologies for Remote Data Acquisition in Clinical Investigations Guidance for Industry, Investigators, and Other Interested Parties (FDA, 2023) See https://www.fda.gov/media/155022/download (accessed September 9, 2024).

Dorsey pointed out that many medical schools do not have the infrastructure to train clinicians to become trial investigators. Creative solutions are needed. As an example, Dorsey mentioned that AdvaMed is collaborating with the National Medical Association (NMA) and other interested organizations on Project IMPACT 2.0 to increase participation of minoritized groups in clinical trials.²¹ One component of the project involves identifying NMA members who may already be researchers who are interested in training to become clinical investigators.

Adam recalled the discussion by Rivers of the Robert Winn Career Development Award, sponsored by the Bristol Myers Squibb Foundation and other partners, which supports clinical research training of medical fellows from diverse backgrounds.²² Adam said FNIH is very interested in this model and has had conversations with Winn about how the program might be scaled. Adam also mentioned the Washington University in St. Louis Medical Apprenticeship Program, registered with the Department of Labor, which combines coursework with on-the-job training toward earning a medical assistant or medical administrative position credential. Apprentices take a national certification exam after 12 weeks of classes, after which they are employed full time in a university clinic for the remainder of the 1-year program; apprentices are encouraged to stay with the university upon program completion.

Nwanyanwu noted the over 100 historically black colleges and universities (HBCUs), and although only four have medical schools, others have health career programs, such as schools of pharmacy or nursing. She suggested that HBCUs and other minority-serving institutions should be engaged at the start of research efforts to increase community engagement and ensure sustainability of clinical trial and clinical research workforce diversity. Thanh Hai said the FDA OND Research Participation Program conducts regulatory science and drug development research, hosts Oak Ridge Institute for Science and Education Fellows, who research under the mentorship of FDA scientists,²³ and does outreach to HBCUs to inform students about this opportunity.

SUSTAINING IMPROVEMENTS IN CLINICAL TRIAL DIVERSITY

Nwokedi-Nwaneri said that to sustain improvements in clinical trial diversity, it will be necessary to “engage collaboratively [and] ensure that

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²¹ “The National Medical Association is the largest and oldest national organization representing African American physicians and their patients in the United States.” See https://www.nmanet.org/page/About_Us (accessed September 9, 2024).

²² See Chapter 2.

²³ See https://orise.orau.gov/ (accessed September 9, 2024).

our investments are synergistic.” Adam also emphasized the importance of collaboration for enhancing sustainability and reducing redundancy of efforts, which will help avoid “reinventing the wheel.” Darien noted that the trials ecosystem spans multiple sectors, and she encouraged participants to “prioritize cultivating and sustaining partnerships with communities, with families, and with patients.” Dorsey highlighted the need to “talk about health equity in the context of optimizing health care outcomes for everyone” rather than perpetuating perceptions that it is only for the benefit of a particular population. Subbiah said it would be helpful to have an advisory body of key constituents that could answer questions from those “on the front lines,” such as a clinician trying to overcome a barrier to enrolling a patient or a sponsor facing a challenge with a decentralized trial.

CLOSING REMARKS

Lewis-Hall reflected on some of the key themes across the workshop discussions.

• “There has been progress, but not nearly enough.” There is still much to be done, but Lewis-Hall expressed hope that, after decades of work, clinical research is ready to pivot toward equitable representation.
• “If you want to be trusted, be trustworthy.” A strong recurring theme was that the clinical research enterprise “needs to work with commitment and consistency within the communities that we want to reach and serve,” Lewis-Hall said.
• Engage communities as true partners. There was much discussion about the need to stop reaching out to communities only when something is needed from them and then leaving afterward (“helicoptering in”). “Find meaningful ways to create and sustain partnerships [with communities],” Lewis-Hall said.
• Improving clinical research will improve clinical care. It was acknowledged that the U.S. health care system is rife with inequities. However, it was felt that efforts to improve the diversity of clinical trials would generate the evidence needed to better serve the health needs of all patients and drive change in the health care system.
• Understand the uniqueness of patients. While study data might indicate a certain percentage of people experience a certain effect of a product, “when it happens to you, it is 100 percent,” Lewis-Hall said. Increased diversity will facilitate better understanding of the unique responses of those who will use a medical product.

• “Develop a business plan and a funding stream.” Lewis-Hall noted both a moral and a scientific imperative for representative clinical trials. But there is also a business case to be made for diverse and inclusive clinical trials. Throughout the workshop, panelists discussed the need to develop business plans and secure funding streams that will support stability, sustainability, and scalability of such trials.
• It is time “to move from strategic planning to strategic action,” Lewis-Hall said, paraphrasing Rutter. She observed that a sub-theme across much of the discussions was the need to move from talking to doing and start putting ideas into practice.
• Partnership and collaboration are essential. Individuals and organizations have been trying to address the lack of diversity in clinical trials from their perspective for a long time. But the importance of collaboration and partnership to share information and resources was a clear theme across the discussions, Lewis-Hall summarized.

Lewis-Hall circled back to the National Action Plan presented at the opening of the workshop. She encouraged participants to read it, consider it, and provide feedback and insights. This is “an all-hands-on-deck opportunity” to effect change, she said. (See Box 6-1.)

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