8

Considering A Path Forward

During the final session, panelists explored some of the key themes that emerged throughout the workshop discussions, lessons learned from current programs and policies, and potential near- and long-term approaches to achieve a more person-centered, culturally aware research and development (R&D) workforce. Tammy Collins, a program officer at Burroughs Wellcome Fund, moderated the session and encouraged participants to consider practical next steps for themselves and the field as a whole.

OPPORTUNITIES FOR STAKEHOLDERS

Katherine Tuttle, the executive director for research at Providence Health Care, said that every stakeholder in the clinical research space has a role in building a more person-centered, culturally aware workforce. To address the lack of professional education focused on therapeutic development and clinical trials, Tuttle called on health professional societies to offer more targeted training programs in clinical and translational sciences. She suggested that patient advocacy groups are needed to keep the focus of clinical research on patients, provide training for patients as partners in research, and develop pathways for patients to contribute across the translational research life cycle.

Tuttle shared an example of partnering with patient advocates from her work on the Kidney Precision Medicine Project¹ where patients with kidney disease helped define and design the studies, were involved in every step of execution, and served on every committee. According to Tuttle, their partnership in this study “changed the science” by helping scientists understand what problems are important to patients. This

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¹ For more information, see https://www.kpmp.org/ (accessed March 5, 2024).

invaluable perspective affects the focus of research even in the preclinical discovery phase which is designed to lead to better diagnostics and therapeutics, she said. Another group of critical stakeholders in the ecosystem are health systems. “If we are going to succeed with clinical trials, we need to align both the clinical and research priorities around the greatest unmet needs,” Tuttle said, and the health care system is where this can happen. A striking example of this type of alignment was seen during the early days of the COVID-19 pandemic, when health care systems could only address patients’ needs through rapid implementation of clinical trials at the point of care.

Envisioning a 2030 Clinical Trials Workforce

Tuttle offered five priorities for the next 5–10 years related to the future clinical trials workforce. Tuttle first mentioned the importance of building a team science ethos across specialties and disciplines. From preclinical to clinical science, having forums for investigators, coordinators, data scientists, administrators, clinicians, and others to talk to one another and work together to solve unmet needs would be valuable, she said. Second, Tuttle contended that specific career pathways for different roles should be developed and that role-specific training that leads to certificate programs to support career ladders should be available. Third, there are many people involved in the clinical research enterprise, she said, and their roles and responsibilities should be clearly delineated. Furthering this point, Tuttle maintained that there is a need for professional expectations and boundaries to be established and achievable milestones for career progress to be set. To create a sustainable clinical trials enterprise, Tuttle said, a fourth priority is to ensure that there are opportunities for career growth and advancement, stressing that “we need to value equitably the different roles on the research team without hierarchy” and base promotion on objective criteria. Finally, she pointed to the need for nontraditional entry into clinical research careers. Tuttle observed that there are many health care professionals working in the system, including technical and clinic staff, who may not have a 4-year degree but are interested in helping patients and solving problems. As an example, Tuttle has found that medical assistants make excellent clinical research coordinators because they have the basic skills they need and often “blossom” when given the right training and opportunities. While some individuals may not opt to go to graduate school, they can participate in on-the-job training and become valued members of the research team. Another group to consider as potential recruits to the clinical research enterprise is older adults—people with experience and wisdom who may be looking to shift in a different direction.

Reflecting on Lessons Learned

Based on her own experiences as well as the discussions throughout the workshop, Tuttle presented a list of “lessons learned” regarding the workforce and divided them into two groups: what works, and what needs to be done better. She identified several promising practices, policies, and programs, including:

• Remote work when possible and flexible schedules to facilitate recruitment and retention;
• In-house training to increase role-specific skill sets and career satisfaction;
• Teams within teams (e.g., lab groups, research coordinators, data center) to promote collaboration and morale; and
• Investigator-led team meetings to increase efficiency and sense of purpose.

These practices, Tuttle said, promote collaboration, increase morale, and make workers feel like they are “part of something bigger.” She went on to contend that a lot of supporting the workforce is “inspiration, team building, and valuing the roles of the people who make all of this enterprise possible.”

Tuttle identified some places for improvement in the clinical research world, such as:

• Institutional level support should be more apparent to the actual research teams doing the work;
• Infrastructure for research operations is often a second-level priority for investment by health systems;
• Recognition is often lacking for the critical role of researchers in developing therapeutics for unmet clinical needs; and
• Health policy could promote research at the point of care to increase access and equity in clinical trial participation.

Tuttle raised the issue of a lack of clinical investigators on the ground. She noted that general practitioners make important observations every day and suggested that pragmatic trials should be designed so that the person in daily practice can make research part of what they do every day. As an example, Tuttle said that the Providence internal medicine residency program launched a few clinical trials, which allow students to gain exposure to trials work and may help inspire them to continue in research as they enter clinical practice.

CONSIDERING NEXT STEPS

Following Tuttle’s presentation, Collins moderated a panel discussion to consider priority goals that should be met over the next 5 to 10 years to help ensure that the workforce meets the needs of the 2030 clinical trials enterprise. Ann Taylor, formerly at AstraZeneca, said that clinical trials are part of the care continuum, so working to ensure that everyone has equitable access to trials is an important step toward health equity. A second priority, she said, is gathering information on the clinical trials enterprise and its workforce. Taylor noted that multiple workshop speakers indicated that there is a shortage of data in this area, which is needed to understand the baseline for improvement. Collecting diversity data on the drug R&D workforce, Taylor said, will require making a number of important decisions on issues related to consent, standard definitions, as well as data storage and use. Putting researchers through the process of disclosing their own personal information, Taylor suggested, may also improve their ability to collect this type of information during the course of their work.

Julia Tierney, the chief of staff in the Office of the Commissioner at the U.S. Food and Drug Administration (FDA), said that FDA has several near-term priorities related to the clinical research workforce. First, the FDA is focusing on policy development. Tierney pointed to FDA’s policies on diversity action plans and diversity goals as well as policies to facilitate the adoption of different tools and technologies. For example, FDA recently established the Digital Health Advisory Committee² to seek input from subject matter experts and advise FDA on how to support the safe and effective regulation of digital health technologies used in innovative trial designs (e.g., decentralized trials). Tierney said that FDA is working to develop pathways for pragmatic clinical trial design in the preapproval and post-market space and considering how data science, artificial intelligence, and machine learning may be useful. Giving people a regulatory pathway forward, Tierney said, makes for a more inclusive clinical trial enterprise.

Menetski suggested that many of the issues discussed during the workshop are applicable not just to clinical research, but also to preclinical and basic science. When it comes to better drug R&D training—from early biology and chemistry through drug development, approval, and therapeutic use—he asserted that early career training for young scientists often runs counter to the team-science-based approach of industry.

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² For more information, see https://www.fda.gov/medical-devices/digital-health-center-excellence/fda-digital-health-advisory-committee (accessed March 5, 2024).

Rather than individual companies each conducting their classes and programs to retrain incoming staff, Menetski suggested that a more efficient approach could be for a consortium of industry stakeholders to build a common drug development curriculum that would be applicable across organizations. This type of collaborative approach would be better for the companies, the workforce, and the science overall. Menetski suggested that this type of training could be a mechanism to raise awareness and understanding of the different roles involved in drug R&D and to engage academic leaders who are training the next generation of scientists.

Tuttle reiterated an earlier point about the importance of implementing policy to drive pragmatic and point-of-care research. This approach could accomplish a couple of goals. First, more patients would participate in research and receive the benefit of “upgraded” care through the clinical trial. Even in the placebo group, she noted, patients are guaranteed the standard of care and associated visits and tests. Second, providers who are accustomed to doing clinical research as part of their day-to-day work often become early adopters of new innovations and would not need to be retrained on how to deliver care when a new drug or treatment comes to market. Finally, point-of-care trials can solve big problems for patients and communities by providing access to the latest treatments. For example, sodium-glucose cotransporter-2 (SGLT2) inhibitors are a “blockbuster breakthrough” for patients with diabetes and kidney disease, yet less than 10 percent of these patients receive this treatment (Thomas et al., 2023). “Training people to do research in the course of the work they do every day is an investment in solving the problem,” Tuttle said. Following up on the idea of making an investment, Taylor added that since these priorities cost money, they should be considered in terms of the business case. Institutions need to see that the money they invest now will pay off in the future in the form of a more sustainable and effective clinical research enterprise, Taylor said, as this “return on investment” mindset is useful in encouraging stakeholders to prioritize funding toward these priorities.

Given these priorities, Collins said, what are the practical next steps that need to be taken, and who are the key stakeholders that need to get involved? Menetski said that it is essential to work both on the local level, with local community members, as well as with the federal government. “Local people only listen to local people,” Menetski said, but the reach and power of the federal government can be used to start conversations and reinforce local efforts. Tierney agreed and said that agencies at the federal level are trying to expand beyond their traditional stakeholders to groups that they have not generally engaged with. For example, Tierney said, while FDA has a big role to play in this space through their fellowships and career pathways, working with other agencies such as the Department of Education could further efforts aimed at educating

the future R&D workforce. She said that there are currently higher-level coordination efforts (e.g., White House councils) that are doing the work to bring together different agencies to collaborate on common goals. On the local level, Tierney said, Zoom and other technologies have allowed stakeholders to communicate more easily with communities and reach new groups of people at the local level. She joked that during the pandemic the director of the Center for Biologics Evaluation and Research, Peter Marks, would make time to talk to a local parent teacher association about the vaccine development process if they invited him. These tools can be used to build scientific literacy in our communities, Tierney said.

Sustainable Scaling

Noting the breadth of programs and practices discussed at the workshop, Fuhrmann asked panelists how these efforts will be sustained and how they can be scaled up. She noted that there is incentive to innovate and there is funding available for developing and testing new ideas. However, she added, once an idea is established, there are fewer funds available to support longer-term training and sustainable implementation. Scaling is a challenge as well, Fuhrmann said, and disseminating an idea to others is not as simple as publishing a paper since people need support to adapt a model for their population and then implement it. Menetski pointed to a supply-and-demand issue with workforce training programs. If potential clinical research professionals are not aware of career opportunities in the field, Menetski said, then they are not going to seek that type of training. However, Menetski contended, efforts to educate people on these career opportunities will help build demand for training. While this will take time, he suggested that sustainability will be driven by the success of the students—if one institution establishes a training program and students go on to have successful careers in R&D, other institutions will take note and start similar programs. However, Bryant-Friedrich said, not all institutions have the same resources or the ability to develop and implement such programs. At the end of the day, she said, it is critical to transform institutions so that they can train people to think about why they are pursuing a line of work and humanize this approach.

CLOSING REMARKS

Watanabe and Butts discussed some key themes that they had gathered from the workshop discussions and shared their thoughts on next steps. Watanabe said he hoped that workshop participants would go out into the world and back to their organizations with a mindset of

inclusiveness—a view that it is vital to work with others, particularly those who have not traditionally been included, and to develop plans for implementing, scaling, and sustaining approaches for increasing workforce diversity. Watanabe highlighted the need to collect more data on the current workforce because “what gets measured gets managed.” He went on to stress the importance of codifying change through policy to set expectations and support accountability. Watanabe called on workshop participants to recognize the community value and expertise of retail pharmacies that have recently entered the clinical research space and may offer opportunities for training the future clinical trials workforce. Further, Watanabe urged researchers to learn more about zip code and neighborhood of association (ZNA) and consider ways to better incorporate social determinants of health into clinical research. Watanabe ended his remarks by emphasizing that improving workforce inclusivity will bolster the science.

Butts urged participants to look “beyond the actual molecule” and focus on the people involved throughout the drug R&D process. She said that when the workshop began with the stated goal of developing a more person-centered, culturally aware R&D workforce, she recognized that “person-centered” not only pertains to the participants in research, but also to the people who make up the workforce. Butts said that people in the workforce—from investigators to nurses to study managers—should feel valued and part of something bigger. Based on the examples shared during the workshop, Butts expressed hope that change to the clinical trials enterprise is “around the corner.” She maintained that in raising awareness and increasing access to successful approaches, there are near-term next steps that could help break down silos. Butts implored workshop participants to look beyond the scientists and academics within the workforce and to consider ways to include the communities in which people live and work. She emphasized the value of including communities as they support and influence the individuals who will become a part of the future clinical trials workforce.