Preparing the Future Workforce in Drug Research and Development: Proceedings of a Workshop (2024)

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Examining the Current State of the Clinical Trials Workforce

THE SCIENCE OF OUTREACH AND ENGAGEMENT

Robert Winn, the director of the Virginia Commonwealth University Massey Cancer Center, opened the session by sharing some of his experiences working to improve diversity in clinical trials. Prior to 2020, Winn had been in discussions with the Bristol Meyers Squib Foundation and other stakeholders about the difficulties in getting minority patients enrolled in clinical trials. There was a “divide and conquer” attitude in clinical trials, he said, with some professionals doing outreach and engagement with communities and others conducting high-impact clinical trials. According to Winn, each side was frustrated at the lack of progress, but they were “talking past one another” and did not understand the processes and challenges of the other side. To address this gap, Winn set up a pilot project to design inclusivity from the start by bringing the science of engagement and the science of clinical trials together. The project expanded into a national project in the wake of the George Floyd murder in 2020. The vision of the Robert A. Winn Diversity in Clinical Trials Award Program¹ is to “transform the clinical research landscape by building and strengthening partnerships between clinical investigators and the communities where their patients reside, with a goal of ultimately engaging a patient population that mirrors the epidemiology of the disease studied.”

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¹ For more information, see https://diversityinclinicaltrials.org/ (accessed February 22, 2024).

Immersing clinical trialists in the science of outreach and engagement was a “big, bold decision,” Winn said, as community outreach and engagement have been considered by some as “soft” or “somebody else’s problem” even though there are decades of supporting literature and frameworks showing this to be a critical component for effectively carrying out clinical trials. The project focused initially on training a cohort of early-stage investigators to become a new generation of community-oriented clinical investigators. Winn pointed to the value of community-based knowledge and understanding—assets that must be respected and combined with clinical research training.

This Community-Oriented Clinical Trialist² training consists of a 2-year curriculum that includes community engagement activities, an annual conference, mentoring, individual professional development plans, and a capstone project. Learners attend lectures and hear from experts in both clinical research and community engagement. The program has now expanded to multiple cohorts and added ongoing career and leadership development support for graduates. The graduates of the program have demonstrated that that they can work effectively and connect with communities, Winn said, and these skills are being recognized by potential employers and other stakeholders.

Winn stressed that “we need to quit acting like minorities and rural people don’t want to be on trials.” He encouraged stakeholders to be bold and have courage when talking with communities. “Don’t talk at folks—speak to them, and with them,” he said. With care and attention to the approach and the messaging, communities are willing to listen and participate.

CRITICAL GAPS AND ANTICIPATED NEEDS

Following Winn’s presentation, Lamont Terrell, the diversity, equity, and inclusion lead of R&D at GlaxoSmithKline, moderated a panel discussion. The discussion began with panelists describing their recent work in the clinical trials space and continued with questions from Terrell and workshop participants.

Taking Advantage of a Community-Based Workforce

Ramita Tandon, the chief clinical trials officer at Walgreens, said that Walgreens has nearly 9,000 stores and pharmacies across the United States and that 78 percent of the U.S. population lives within 5 miles of a store

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² For more information, see https://diversityinclinicaltrials.org/winn-cda/ (accessed February 22, 2024).

(Walgreens, 2024a). Given this reach, Tandon asked, how can this infrastructure be used to deliver and improve health care? Tandon said that many communities that Walgreens serves have limited familiarity with clinical trials and some have a history of mistrust and misinformation with health research. Tandon emphasized the importance of empowering and educating local communities to help ensure they receive information on the benefits of clinical trials and have an understanding of trials as an extension of clinical care.

To do this work, Walgreens has begun identifying relevant patients among their 120 million clients to match patients with trials (Martell, 2021). Walgreens has activated locations to become clinical trial centers, training pharmacists on research mechanics. Pharmacists already have significant engagement and trust with people who frequent Walgreens stores, Tandon said, so there was an opportunity to facilitate dialogue between pharmacists and the people they serve concerning participation in clinical research. Walgreens’ goal, she said, is to tackle issues related to the lack of diversity and to make trials more accessible and convenient for all communities the company serves. Walgreens is currently participating in over 20 clinical trials and partnering with multiple organization and communities to support the conversation around clinical trials (Walgreens, 2024b). Tandon said that Walgreens and other retail pharmacies are using lessons learned from the COVID-19 pandemic when they had to step up and administer millions of vaccinations. The pandemic experience required partnerships, nontraditional thinking, and building trust and communication with communities. These insights, Tandon said, are being applied to the clinical research ecosystem that Walgreens is creating.

Blayne Cutler described her work as president and chief executive officer at Heluna Health, a large nonprofit organization that is carrying out approximately 500 different public health projects across the country (Heluna Health, 2022). Heluna Health works to serve as a bridge between the scientific community and the community at large. In her work on HIV (human immunodeficiency virus), Cutler witnessed the activism of communities, and noted the phrase “nothing about us without us.” At Heluna Health, Cutler and her colleagues are working to train people with “deep lived experience in communities,” such as promotoras and outreach workers. With training on science and clinical trials, these individuals can serve as translators and communicators between the scientific world and the community at large. The Heluna Health Pathways program has developed training modules and curricula based on California’s core competencies for community health workers to serve as a standard across

the country for this growing and important cohort of workers.³ Cutler said that state and local health departments are realizing the importance of these workers, as the Bureau of Labor Statistics estimates that this workforce will grow by about 14 percent over the next 10 years (BLS, 2023). Through its training, Heluna Health is working to ensure that this community-based workforce is grounded in the science of clinical trials and that they are well prepared to facilitate partnerships between communities and scientists.

Creating Pathways for Physician Scientists

Linda Demer, the executive co-director of the Specialty Training and Advanced Research (STAR) Program at the University of California, Los Angeles (UCLA), talked about her work with physician-scientists in the clinical trials workforce. Physician-scientists are a “rare and endangered species,” Demer said, in part due to changes in the clinical education of medical students. Demer added that the physician-scientist workforce lacks diversity, in part, because a career path that requires a medical student to take time off to pursue a Ph.D. is generally “for the privileged class.” As a program director at UCLA, Demer started a program to train physician-scientists at the level of fellowship rather than at the level of medical student. This allowed learners to carry out their Ph.D. later in their training when they are making a decent salary. In addition, doing the Ph.D. later means that the fellows are better prepared and can finish their Ph.D. more quickly than typical graduate students. Demer said that the first group of five fellows in the program was diverse and that later cohorts have continued this trend. For people from underprivileged and marginalized groups, Demer said, having “the Ph.D. after their name makes a big difference.” The program has added a master of science in clinical research, opening the door for clinical trialists and providing a variety of paths. The graduates of the UCLA STAR⁴ program have become leaders in their fields, she said, with graduates serving as program directors, division chiefs, department chairs, leaders in pharmaceutical companies, and a university president.

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³ For more information, see https://helunahealth.org/programs-and-services/ (accessed February 22, 2024).

⁴ For more information, see https://medschool.ucla.edu/education/residencies-and-fellowships/programs/ucla-star-program (accessed February 22, 2024).

Communicating Trust and Building Trustworthiness

Panelists engaged in discussions about the importance of building trust, emphasizing that institutions should be transparent and open with the public. According to Winn, institutions should make a concerted effort to be trustworthy; he made the point that “trust” is something given by someone else versus “trustworthiness,” which is something that can be built from within. Trustworthiness can be built, measured, and improved upon, Winn said, but many health institutions have not invested in this type of work. On that note, workshop participant Heather Pierce, the senior director for science policy and regulatory counsel at the Association of American Medical Colleges (AAMC), pointed to the AAMC Center for Health Justice, which has developed a Principles of Trustworthiness Assessment Toolkit⁵ for organizations and institutions. Pierce said that the assessment is based on a set of 10 principles that were co-developed by AAMC and community members. This tool, she said, allows institutions to self-assess, set a benchmark, and improve their trustworthiness.

Tandon said that one of Walgreens’ goals is to open the lines of communication and build trust between scientists and the public. Communication and trust are critical for educating the public about clinical trials and facilitating enrollment and retention, she said. Cutler agreed that trust is essential and added that “communities have long historical memories.” In her experience, people have continued to remember and bring up events such as the Tuskegee syphilis study,⁶ which happened nearly 100 years ago. It is important that scientists understand how history has affected communities and how that may in turn affect efforts to be trustworthy and build trust. Winn added that he once held a “science camp for community,” in which faculty members were paired with community members and had to learn how to explain their work in a way that was understandable. At the end of 8 weeks, the community members decided whether the faculty member passed the test; he noted that some had to do “remedial work.” If science is meant to affect people, Winn said, “we need to be much more sophisticated, nuanced, and effective in our communication.”

In order for scientists to communicate effectively with people—whether the public or individual patients—they need to understand the perspective of the other party, Cutler said. For example, a clinician may assume that simply telling a patient to stop smoking will be effective. However, Cutler asserted that the message needs to be “important and

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⁵ For more information, see https://www.aamchealthjustice.org/our-work/trustworthiness/trustworthiness-toolkit (accessed February 22, 2024).

⁶ For more information, see https://www.cdc.gov/tuskegee/timeline.htm (accessed February 22, 2024).

valuable to [the patient] in their cultural universe” to have an impact and make them want to change their behavior. Applying this paradigm to the clinical trials space, Cutler said, means that scientists need to try to understand the participant’s perspective and think about why a participant may or may not want to take part in a trial.

Evolving Roles and Expertise

Terrell asked panelists to think about the traditional roles and expertise that are required at different stages of drug development and to consider how these have evolved over the last 10 years. Winn responded that while many things have changed in the field, institutions are slow to catch up and to adapt. For example, he said, academic institutions are still trying to figure out how to teach learners about data, artificial intelligence, and machine learning. Winn said that resistance to change is due in part to fear of making mistakes; however, mistakes are “going to happen, particularly when you do great things.”

Walgreens is in a unique position, Tandon said, because it holds a plethora of information on its consumers and patients, including information on social determinants of health such as race, gender, ethnicity, education, and income. This information can help inform the workforce on how best to engage with communities both inside and outside of Walgreens. Tandon said that even the best communication about a clinical trial opportunity may not resonate because there is no “community surround sound” about what clinical trials are and the benefits of participating. Walgreens is taking advantage of its consumer information to shape engagement so that when a clinical trial opportunity arises, people are equipped to respond to the call to action.

Cutler said that the gap between the scientific community and the general population remains large, despite efforts to build bridges. Scientists tend to underestimate how aspects of community members’ day-to-day lives—such as issues of childcare, employment, or accessing benefits—may complicate their participation in a clinical trial. There is a need for scientists to better understand the communities in which they operate, and to work on building communication and trust. She added that groups of people that connect the scientific community to the general community, such as community health workers, are a critical yet under-resourced and undervalued workforce. These workers tend to be primarily female, and structural barriers, including pay and support, remain obstacles (Jones et al., 2022).

Winn encouraged stakeholders to pursue a “high tech and high touch” approach, in which new innovations are thoughtfully implemented based on considerations for community-based access, infrastructure, and equi-

table use. Demer suggested that building a more diverse workforce is one way to address this issue, because the design process and trials will be informed by people with community knowledge. She expressed concern that there are not enough people joining the workforce from remote and rural areas.

Funding Community Engagement

A workshop participant noted that although community engagement requires planning, time, and funding, funding entities often do not take these factors into account. Cutler suggested that one place to begin is by conducting a community assessment to understand the needs and strengths of the community. Such an assessment can be used to identify community leaders and better understand the potential resources that communities can offer. Furthermore, community assessments serve to educate funders about the community and may encourage specific funding for community engagement and training within the budget of a project. Demer added that if scientists want diverse clinical trials, they should consider ways to facilitate participation by diverse communities. For example, a recent study found that the diversity of a trial hinges in large part on whether there is specific funding to translate the informed consent form (Velez et al., 2023). Individuals who have physical disabilities or who are neurodiverse may need certain accommodations or different communications to be recruited into and participate in a trial, Demer said.

Winn agreed that including community engagement plans or assessments within the budget of a project is critical, but also a challenge, saying that it is not “standard practice” and that pools of money for engagement are often not “readily available.” However, as people continue to work in communities and gather information on why engagement is critical, Winn said he has seen “lightbulbs” go off as more trialists recognize its importance. Cutler added that in California, there are efforts to experiment with “true whole person care” by reimbursing for services such as community health workers and doulas (DHCS, 2022, 2023). The funding for this project is due to a budget surplus, so it remains to be seen if it will continue. Cutler emphasized that the data demonstrate the importance of community engagement, and using these data can be helpful for securing funding. For example, one study found that for every one dollar spent training a community health worker, 11 dollars are saved in eventual health care costs (Rural Health Information Hub, 2023).

Understanding DNA and ZNA

A workshop participant said that in her work as a basic scientist, there is a lot of focus on the single cell. Increasingly, there has been a movement to take a high-dimensional view of single cells by looking at the genome as well as the cell’s space and time within a tissue. Drawing an analogy to the interaction between DNA (deoxyribonucleic acid) and ZNA (zip code and neighborhood of association), she asked how scientists can learn to analyze the various contributors to health together, rather than looking at them as covariates that need to be corrected. Winn asserted that most conversations about health disparities focus on race and ignore the importance of place—that is, they focus on DNA rather than ZNA. “If we start understanding the science of the ZNA and the intersectionality of that with the biology of the DNA,” he said, a better understanding of the infrastructure needed to solve the problems of disparities in access and outcomes can be achieved.

Following on the analogy to the focus on single cells, Winn said that when he previously worked as a cancer epithelial cell biologist, it was thought that the epithelial cells were the cause of lung cancer. Further research demonstrated the role of the stroma around the cells and the interaction between them. In talking about individuals and communities, he said, “we never talk about the stroma around them.” The “zenome” of a person—that is, their place and space—makes a big difference to their health. For example, the life expectancy in Illinois is about the same as the rest of the country, as is the life expectancy in Cook County. However, a “precision medicine” view of the county reveals that there is a 30-year difference in life expectancy between different neighborhoods (Schencker, 2019). To understand the interplay between the genome and the zenome, Winn said, there is a need to bring people from multiple disciplines together for “convergent science” that uses the knowledge of both the bench and the community.

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