7

Policies for Workforce Sustainability and Future-Proofing

This session of the workshop focused on guiding principles for stakeholders and policies, procedures, and actions that could be implemented to build a more person-centered, culturally aware research and development (R&D) workforce. Lola Fashoyin-Aje, the associate director of the Oncology Center of Excellence and deputy director of the Division of Oncology III within the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA), moderated the session. The session began with a presentation by Elizabeth Ofili, a professor of medicine at Morehouse School of Medicine, who set the stage for discussion.

PERSON-CENTERED APPROACHES

Ofili shared an image of an iceberg depicting different data sources that could be used to achieve deep evidence-based medicine (Figure 7-1). The tip of the iceberg represents the current evidence-based medicine that, according to Ofili, is “very limited in terms of evidence base to support how we conduct clinical trials overall.” Ofili explained that the types of data beneath the “water”—from wearable technologies to real-world data to electronic medical records—have strong implications for the kind of future workforce needed to support and sustain research as they must learn to use all of these available data. Although it can be daunting for stakeholders to consider how to plan for the future clinical trial enterprise, Ofili emphasized that it is a process of reinvigoration rather than inventing new things. To address pain points along the clinical trials enterprise, she said, it is important to understand how to leverage all of the knowledge and tools “coming down the pike” and learn from what has happened in various research programs.

Ofili said that during the COVID-19 pandemic a number of models were developed and used for remote approaches and decentralized clinical trials, including telemedicine, using local labs, and remote and statistical monitoring. Because some of these will likely continue into the future, Ofili said that there is a need to consider how the workforce for these approaches may differ from the traditional clinical trials workforce. Furthermore, Ofili offered details of a late-breaking clinical trial she was a part of that investigated the implementation of the Health360x registry to provide equitable access to point-of-care decentralized clinical trials (Ofili et al., 2023). The registry integrates social determinants, Ofili said, which is important because while patients are at the center of clinical research, “we don’t know how to get to them and sustain them, why they participate, and perhaps why they will not participate in the future if we don’t get it right.” Ofili emphasized that it is critical for clinical researchers to place patients at the center of what they do and work to harmonize issues that patients care about with data researchers need.

Turning to her work with the Research Centers in Minority Institutions (RCMI) consortium,¹ Ofili told participants that RCMI are “ready for many aspects of diversity and inclusive excellence” as several of the institutions are those that have historically served minorities, including historically black colleges and universities (HBCUs) and institutions that work with Native Hawaiians and Pacific Islanders. These institutions were awarded this competitive award, she said, because they are connected to these populations and have a strong focus on developing investigators. A coordinating center ensures that the institutions in the

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¹ For more information, see https://rcmi-cc.org/ (accessed March 3, 2024).

consortium are collaborating and cooperating, though each institution has different goals. Ofili provided some statistics that demonstrate the extent of the collaborations in this group (RCMI Coordinating Center, 2024):

• 1,300 scientists in health disparities research
• 10,000 articles and papers published by RCMI investigators
• More than 1,000 R-01 awards across the consortium

Morehouse University School of Medicine is a member of the RCMI consortium and also has received a clinical and translational science award² (CTSA) from the National Center for Advancing Translational Science at the National Institutes of Health (NIH). CTSA program hubs collaborate to develop, demonstrate, and disseminate innovative methods and technologies to turn scientific discoveries into clinical advances more efficiently. Specifically, the hubs use funding to address training opportunities, to provide infrastructure, and to conduct community engagement. Ofili said that the Georgia CTSA, in partnership with Morehouse and other universities in the state, provides an opportunity for diverse individuals in the predoctoral or postdoctoral phase to received mentored research training through their TL1 program.³ This program provides support and resources for these individuals to move their careers forward in the clinical or translational space, Ofili said.

Ofili described some opportunities to develop policies and procedures to ensure a more person-centered and culturally aware R&D workforce. First, she said, it is essential to keep people and patients at the center of the R&D enterprise. Ofili contended that as digital innovation advances, research participants should be considered as partners in the research and as citizen scientists since they now have the ability to collect and donate their own data, as illustrated by the NIH All of Us Research Program.⁴ Second, Ofili suggested that federal agencies should prioritize metrics for inclusive excellence in R&D workforce programs, incentivize community-centered partnerships, and support industry collaborations to sustain these programs. Third, a sustainable career path for clinical trial physicians, especially those working on multidisciplinary teams, is needed, and promotion and tenure policies at the institutional level should be put in place to value their work, Ofili said. Fourth, she emphasized the need to develop a pipeline for training and certification of research coordinators,

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² For more information, see https://ncats.nih.gov/research/research-activities/ctsa (accessed March 3, 2024).

³ For more information, see https://georgiactsa.org/training/tl1.html (accessed March 3, 2024).

⁴ For more information, see https://allofus.nih.gov/ (accessed March 4, 2024).

potentially partnering with institutions such as community colleges or HBCUs to provide culturally aware mentorship to this workforce. Fifth, Ofili called for policies that support the growing role of data scientists given that data science is the future of clinical trials and everyone in the ecosystem needs to understand how to use leverage the expertise of data scientists. Finally, Ofili said, innovation is the key to the future of clinical trials. Artificial intelligence and machine learning, she said, should be integrated into the R&D ecosystem and workforce to reduce inefficiencies. Ofili said that it is critical for stakeholders to understand these innovations, identify potential impacts, and work alongside ethicists and other partners to move forward while avoiding adverse outcomes.

ROLES AND RESPONSIBILITIES

Fashoyin-Aje began the discussion by asserting that “the ultimate goal of developing a sustainable workforce for the future will require multidisciplinary collaboration across teams and across siloes.” While previous sessions covered a number of interesting programs and promising approaches for developing the next generation R&D workforce, Fashoyin-Aje challenged panelists in this session to discuss how to move these ideas forward into policies and procedures. In turn, Fashoyin-Aje first asked panelists to give a broad sense of what should be done in this space and to identify stakeholders that could take action.

Supporting Clinical Research Professionals

Susan Landis, the executive director of the Association of Clinical Research Professionals (ACRP), described the perspective of ACRP, an organization concerned about the deficit of clinical research staff that realizes the need for a more “diverse and research-ready workforce.” A more diverse staff will lead to a more diverse study population, Landis said, adding that “patients don’t leave principal investigators who look like them.” In response to these concerns, ACRP convened a consortium across the industry to look at the barriers to entry into the clinical research workforce and identify actions that need to be taken. Landis said that the actions should address issues in three basic areas: awareness, access, and sites.

“There is no identity for clinical research as a career,” Landis said, so it is critical to improve awareness. Landis emphasized in particular two main action items in this area—first, to collect data on the current workforce, and, second, to increase K–12 exposure to STEM education and career opportunities. Landis said that action on education will require the buy-in of stakeholders including colleges, universities, high schools,

the U.S. Department of Education, and state governments; without the approval of state entities, new and expanded curricula will not make it into the schools.

The second category, access, relates to the fact that there is no straightforward path to working in clinical research, Landis said. ACRP and its partners are working to build a career path for clinical research professionals and align qualifications to this path based on shared competencies. The hope, she said, is to eliminate the catch-22 in clinical research; as Wilfond pointed out earlier in the workshop, clinical researchers cannot get hired without experience, but they will not get experience without getting hired (see Chapter 5). Once such a career path is built, Landis emphasized, it will be important to communicate that path and the identified qualifications widely to K–12 institutions, community colleges, and “everywhere in between.”

The third category of focus is on research sites, or the “beating hearts of clinical research,” as sites and their staff recruit and connect patients with research opportunities, Landis said. She added that it costs around $50,000–60,000 to hire and onboard a clinical research coordinator at the site level (Freel et al., 2023). Within 2 years, Landis said, these now well-trained individuals are often recruited by contract research organizations (CROs) or sponsors and offered a signing bonus and salary increase. Landis contended that all stakeholders should “embrace this contribution that sites make to building the workforce of the future diverse and research-ready” and should support them directly and transparently.

The Role of Universities

Cynthia Fuhrmann, an associate professor at the RNA Therapeutics Institute and associate professor of biochemistry and molecular biotechnology at the University of Massachusetts Chan (UMass Chan) Medical School, followed up on Landis’ remarks about the need for building awareness of career paths in clinical research. At the UMass Chan Medical School, Fuhrmann said, she and her colleagues have done “groundbreaking work” by building career planning into the curriculum for graduate students and postdocs through their NIH Broadening Experiences in Scientific Training award. All graduate students are required to participate in a short course that guides them through the process of building their own self-awareness and exploring different career paths. The course connects them with scientists and researchers in different roles, from the bench to regulatory affairs. “This is now part of our culture,” Fuhrmann said, because part of being a scientist is understanding the science ecosystem and the different roles that people play in it. As Landis mentioned earlier, there is also a need to grow awareness of clinical research careers in the

K–12 and undergraduate levels. Fuhrmann encouraged stakeholders to consider the important role that advisors and career centers can play in helping students explore careers. There is an opportunity to use these assets to spread awareness of career paths in clinical research, she said. In addition, Fuhrmann noted that partnerships with industry and others in the field could provide students with opportunities for internships or other ways of gaining exposure to different roles.

Another key action item in the clinical research space, Fuhrmann said, is “humanizing research” by engaging with the public and building trust in science. One of the best places to start this process, she said, is in “our own research environments” where there are opportunities to collect information and make change. For example, in collaboration with the Association of American Medical Colleges, the UMass Chan Medical School developed a diversity engagement survey that can be used by universities across the country to measure diversity-related climate on their campus and within departments.⁵ The tool allows each department to look at its own data and compare metrics—such as feelings of inclusion—with other departments across the country. This survey has been powerful for the departments at the UMass Chan Medical School, Fuhrmann said, and it spurred the development of diversity action plans. Fuhrmann and her colleagues have also launched a new program called the Investigator Career Advancement Program, which is a cohort program for first-year tenure track faculty.⁶ The program supports the cohort through a three-prong approach of professional development, mentorship, and writing support. Through a cluster hiring program, Fuhrmann said, they are attracting candidates who are well positioned to become inclusive leaders.

The Role of Industry

Kenneth Maynard, the director of global program team effectiveness at Takeda, shared some of the actions that are being taken at Takeda to create a diverse and inclusive clinical research enterprise. Takeda has a clinical research education toolkit,⁷ often used in grassroots efforts, that is designed to educate physicians who are interested in the clinical research space and help them engage with communities (Miessler, 2023). Maynard shared a story of a physician who wanted to give a presentation to her

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⁵ For more information, see https://www.umassmed.edu/pqhs/diversity-and-inclusion/diversity-engagement-survey/ (accessed March 5, 2024).

⁶ For more information, see https://www.umassmed.edu/icap/ (accessed March 5, 2024).

⁷ For more information, see https://clinicaltrials.takeda.com/pdf/RD_DEI_Factsheet_V3.pdf (accessed April 9, 2024).

church about a study that was starting soon; Takeda helped her gather materials, translate materials into Spanish, and helped with the presentation. Maynard commented that even on an “unbearably hot” day in New York City, more than 80 people stayed after church to hear the talk. People are willing to participate in research, Maynard said, but they need to know about the opportunities. Maynard called for pharma to engage in grassroots efforts by going into communities to raise awareness of clinical trials and highlight opportunities for community members to provide input during the design process of clinical trials.

Another effort that Takeda has undertaken is the Equitable Trial Access Program, which is designed to educate health care professionals about trials and help them understand how patients can get access to those trials (Grom, 2022; Takeda, 2023). Although clinical trials can be seen as an extension of health care for patients, particularly for those who have “run out of options,” many physicians are not aware of resources such as clinicaltrials.gov, and this is a space where pharma could make a difference and “do better in terms of education,” he said. Finally, Maynard reported that Takeda is undertaking a new project called the De Novo Site Program, which is aimed at partnering with CROs and ensuring that staff working at sites have the knowledge and skills necessary to conduct a quality trial. In addition to training staff and building their confidence, the program will also evaluate what went right and what went wrong during a trial to develop a plan for improvement.

Maynard closed his remarks with a challenge to workshop participants and stakeholders in the clinical space. While “a lot has been written” about all of the issues discussed at this workshop today, he said, stakeholders should have some “skin in the game” as a commitment to get to the implementation phase. Talking about diversity and equity with people who are working on diversity and equity is “preaching to the choir,” he said, and “we cannot continue to have minorities looking after minority issues. We need to have majorities looking at minority issues, and we all need to come to the table.” He asked stakeholders, “What are you going to do? What commitment are you going to make and what are you going to do to help implementation?”

Ongoing Professional Development

A workshop participant noted that there had been a lot of discussion at the workshop about building competencies in educational programs. She wondered if there were programs or plans for upskilling and retraining the existing workforce, noting that the technology sector uses boot camps to update coding skills. Fashoyin-Aje agreed that ongoing profes-

sional development is needed to meet the needs of the workforce. Landis said that ACRP has a broad and diverse education program that follows professionals all along their career journey, even if they pivot to a new role. She said that one of the goals at ACRP is to “build your educations for the future clinical research professional, not for the research professional today.” Landis said that this applies to both the topics explored (e.g., data science) and the methods of training (e.g., virtual reality). Research sites have reported that their main challenges are staff recruitment and retention, technology, budgeting, and regulatory issues, Landis said, and sites need support to learn the new technologies and platforms that are emerging, especially as decentralized clinical trials become more prevalent (WCG Clinical, 2023). Landis said that training on these platforms and training for early career professionals are often not included in a site’s budget. Ofili said that retraining is a “great idea” but emphasized the need for the content of that training to be patient-centered and culturally aware. In addition, there is a need to carefully consider how and when workers will complete this training and how to compensate them for their time. Fuhrmann said that there are several organizations that could serve as partners in midcareer training, such as MassBioEd⁸ and BioKansas.⁹

Highlighting Key Takeaways

As moderator, Fashoyin-Aje offered concluding remarks and identified some key takeaways that she had noticed throughout the session. One key idea that emerged was the need for more exposure to STEM and careers in clinical research as well as education and training within the career path. Fashoyin-Aje emphasized that “we need to better define these careers, provide ways to be certified, and have consistency” so that clinical research professionals receive appropriate training and experience no matter where they work or for whom. She added that these efforts need to be accomplished through collaboration and the sharing of ideas, rather than one-off endeavors siloed by individual stakeholders. In addition, Fashoyin-Aje said, there is a need for linkages across different pathways and programs. She noted that while there are several interventions at specific places in the career path—for example, K–12 outreach, mentoring in graduate school, or internships in undergraduate school—these programs need better visibility and coordination among programs. “Many of us didn’t know that [these programs] existed,” she said, and

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⁸ For more information, see https://www.massbioed.org/ (accessed March 5, 2024).

⁹ For more information, see https://biokansas.org/ (accessed March 5, 2024).

action is needed to address this gap. Professional development has been another key theme, Fashoyin-Aje said, and after training, a degree, or a certification, professionals need continued training in their roles and sectors. Finally, Fashoyin-Aje commented how academic research sites often serve as the “training ground” for research professionals; there is a need to develop policies and incentives to address sustainable funding for this training as part of a long-term investment in the clinical research enterprise.