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Introduction¹

Despite advances over the past several decades, the clinical trials enterprise has struggled to meet the needs of an increasingly diverse U.S. population. As outlined in the 2006 National Academies of Sciences, Engineering, and Medicine (the National Academies) consensus study Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 (IOM, 2006), there is a need to cultivate and diversify the workforce and attract and retain people throughout the clinical research career path. Building on this work, in 2021 the National Academies’ Forum on Drug Discovery, Development, and Translation hosted a public workshop, Envisioning a Transformed Clinical Trials Enterprise for 2030, which served as a venue for people involved in drug research and development (R&D) to reflect on lessons learned over the past decade and consider goals and priority action items that could advance the vision of a 2030 clinical trials enterprise that is more efficient, effective, person-centered, inclusive, and integrated into the health care delivery system (NASEM, 2022). Enabling this future will require, as workshop participants emphasized, a next-generation clinical trials workforce that is resilient, interdisciplinary, inclusive, and reflective of the communities it serves.

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¹ This workshop was organized by an independent planning committee whose role was limited to identification of topics and speakers. This Proceedings of a Workshop was prepared by the rapporteurs as a factual summary of the presentations and discussions that took place at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants and are not endorsed or verified by the National Academies of Sciences, Engineering, and Medicine, and they should not be construed as reflecting any group consensus.

On October 16 and 17, 2023, the Forum on Drug Discovery, Development, and Translation in collaboration with the Roundtable on Black Men and Black Women in Science, Engineering, and Medicine² hosted a follow-on public workshop to explore challenges and opportunities associated with supporting the next-generation drug R&D workforce. Workshop participants discussed the types of expertise and disciplines needed to achieve the aspirations for a transformed clinical trials enterprise in 2030 and enable a workforce that can better support the evolving needs of drug R&D. Workshop participants also considered approaches for engaging and preparing a more person-centered drug R&D workforce. The National Academies appointed an ad hoc planning committee to address the statement of task (Box 1-1).

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² For more information, see https://www.nationalacademies.org/our-work/roundtable-on-black-men-and-black-women-in-science-engineering-and-medicine (accessed March 18, 2024).

OVERVIEW OF THE R&D WORKFORCE

Workshop co-chair Jonathan Watanabe, a professor of clinical pharmacy, the director of the Center for Data-Driven Drugs Research and Policy, and the associate dean of assessment and quality at University of California, Irvine, School of Pharmacy & Pharmaceutical Sciences, provided a brief overview of the drug R&D continuum from early exploratory research through Phase III trials and beyond (Figure 1-1). Watanabe informed workshop participants that the focus of the workshop would be primarily on workforce needs to support the latter half of the continuum—drug development and clinical trials—rather than preclinical work and drug discovery, which may be addressed in other venues.

Drug R&D requires expertise in a range of disciplines, including engineering, science, and medicine, Watanabe said, and it involves people serving in a variety of roles, including those directly involved in clinical research, such as principal investigators and operations coordinators. Additionally, health economists and statisticians may lend expertise in the planning and analysis of studies, while pharmacoepidemiologists and pharmacovigilance experts may help design studies and determine appropriate endpoints. Experts in regulatory affairs may consult with experts in chemistry and manufacturing in addition to engaging with government agencies. Pharmacologists are needed to address pharmacokinetics and pharmacodynamics issues; toxicologists and pathologists are needed to understand toxicology and disease progression. Professionals in project and asset management work within institutions to support coordination between groups, and portfolio strategists and business analysts help ensure that the R&D pipeline is aligned with the needs of the market. These professionals, along with many others, make up the clinical research workforce, and they each play critical and often cross-cutting roles, he said.

One way to visualize the clinical research workforce, Watanabe suggested, is as a series of train lines and stops (Figure 1-2) with each “train line” representing a career path (e.g., regulatory, industry, and clinical research), and each “stop” along the line representing a distinct role within that career path. For example, “stops” along the purple line (see Figure 1-2), which represents a career path in clinical site management, may include the principal investigator, site director, clinical research coordinator, research assistant, and other roles. Watanabe pointed out that the system has become increasingly complex and more integrated over time. Workshop co-chair Cherié Butts, the medical director of the Therapeutics Development Unit at Biogen, noted that this way of looking at the clinical research enterprise emphasizes the importance of each role along each career path since success is interdependent and based on successful performance by people operating throughout the system.

This workshop was designed to help participants consider how to build, improve, and support the clinical trials workforce for the future. Watanabe said that the time for achieving transformation is now, given the impact and lessons learned from the COVID-19 pandemic, which can serve as catalysts for change across the R&D landscape. The pandemic disproportionately affected minorities, exposed health disparities, and ignited public discourse, so Watanabe stressed the need to “strike while the iron is hot” on these issues. He added that achieving health equity will require enhancing diversity in all forms throughout the clinical research workforce. A diverse workforce that is better equipped to understand and respond to the needs and values of underrepresented communities will ultimately lead to more inclusive and effective clinical research. Additionally, a more diverse and responsive workforce will help foster trust and participation among minority groups, thus reducing disparities in health care access and outcomes, Watanabe said.

Watanabe highlighted ongoing efforts, which indicate that there is momentum for meaningful and sustained change. For example, the White House released a report, “Building the Bioworkforce of the Future,” which included recommendations geared toward expanding and diversifying the talent pool for biotechnology and biomanufacturing careers (OSTP et al., 2023). Watanabe said that multiple organizations, including pharmaceutical life science firms, academic institutions, and government agencies, are calling for a new normal when it comes to a more diverse, innovative, and inclusive clinical research workforce. Finally, Watanabe said, “we are in a revolutionary moment of immense change technologically and scientifically.” In turn, Watanabe stressed that the future workforce must be prepared with the skills and knowledge necessary to support the evolving needs of drug R&D while ensuring that marginalized groups are not left behind as technology advances.

Goals of the Workshop

Following Watanabe’s remarks, Butts shared her views on the workshop discussions, which were designed to highlight the interconnectedness of drug R&D across sectors and stakeholder groups. Every role is important and critical, and Butts expressed hope that workshop participants who work in these positions might share their perspectives and expertise with one another. The workshop was designed to capture perspectives from across sectors, career stages, and areas of expertise, encourage action among stakeholders based on discussions and inform the direction of future activities carried out by individuals and organizations. Butts stressed that it is essential that information shared at the workshop not be limited to those in the room, but reach everyone who

could benefit and take action. She encouraged workshop participants to consider, “What can I as an individual do to help advance the solutions discussed; what can my organization do to help achieve the goals that have been outlined?”

ORGANIZATION OF THE PROCEEDINGS

This Proceedings of a Workshop summarizes the presentations and discussions that took place during the public workshop held on October 16–17, 2023. The workshop included breakout group discussions which were facilitated in person at the workshop in Washington, DC.

Chapter 2 provides perspectives on the future state of the clinical trials workforce. Chapter 3 lays out the current state of the clinical trials workforce, including gaps and needs that currently exist. Chapter 4 covers barriers to progress and potential approaches to overcoming these barriers, based on lessons learned from current efforts. Summarized by breakout discussion leaders, Chapter 5 recognizes challenges and practical approaches to progress for particular roles and disciplines within the clinical trials enterprise. An overview of different programs and approaches to developing the future workforce is explored in Chapter 6, followed by a discussion on potential policies or procedures that could be implemented to help further scale and sustain workforce programs in Chapter 7. The proceedings concludes in Chapter 8, which highlights potential next steps and considers near- and long-term approaches to achieve a more person-centered, culturally aware drug R&D workforce.

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