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Exploring the Future State of the Clinical Trials Workforce

EXPERTISE, KNOWLEDGE, AND SKILLS

To prepare the future workforce, Butts said, it is essential to understand what that workforce should have in terms of the expertise, knowledge, and skills to enable a transformed clinical trials enterprise that is person-centered and culturally aware. “The future is here,” she said, so there is a pressing need to take immediate action to prepare the workforce of 2030, while at the same time putting in place measures for the longer term.

To explore these ideas, Butts led a discussion among four panelists. Following Butts’ discussion questions, she moderated a question-and-answer session among panelists and workshop participants.

Building on Big Data

Butts began the discussion by asking panelists to comment on which existing training and expertise will become even more critical for the future research and development (R&D) workforce. Amanda Bryant-Friedrich, dean of the graduate school and a professor of pharmaceutical sciences at Wayne State University, responded that students need to be prepared to handle the huge amounts of data that will be available in the future. One of the key issues, she said, will be to ensure that biomedical professionals can see their data through a lens of community, while also pursuing biomedical advances. Whether in technology, engineering, or social sciences, professionals will need to be able to understand and “humanize” data so that they are accessible and applicable, she said. Susan Monarez, the deputy director of the Advanced Research Projects Agency for Health (ARPA-H), agreed with the need for the future workforce to

be comfortable with data since future clinical trials will require advanced data analytics, large language models, technical interoperability, artificial intelligence (AI), and machine learning (ML). Monarez emphasized that the workforce needs an appreciation and understanding of these technical domains to ensure that clinical trials are conducted in a safe and effective manner. In addition to being comfortable with big data, Monarez said that the workforce will need competencies in managing patient data and, in particular, ensuring that clinical trials protect the security of patient data and comply with ethical guidelines and legal regulations.

“Statistics—the interpretation of data—is such a basic skill I would say every citizen ought to have it,” said Murali Aravamudan, chief executive officer of Inference. For the first time in history, he said, “there is an opportunity to meaningfully use and synthesize all the data that is there, in order to ask very meaningful questions.” However, he continued, it is critical for the person asking the question to know how to understand the answer and “discriminate between truth and falsity.” For example, if a scientist analyzes a Caucasian-centric dataset to look at potential cardiovascular benefits of Ozempic, he or she does not have the full story. The scientist needs to acknowledge the limitations of data and have the ability to ask further nuanced questions. Machines are becoming more capable of analyzing data and making predictions, often without the input of humans and without transparency in analysis. Given these advances, he said, it is ever more critical that humans remain alert and able to reason about data. Aravamudan contended that those working in R&D need statistical literacy skills—to be cognizant of where the data came from, to know how to interpret the data, and to understand the limitations and applicability of the answers the data provide. Butts agreed that this skill set will be essential for the future R&D workforce. Panelists observed that researchers and others involved in clinical trials need to be able to evaluate data and identify factors that may confound or blur the findings, such as differences between racial or ethnic groups or differences among people in different geographic regions.

Embracing Diversity and Enabling Resiliency

“Soft skills,” including resilience, cultural awareness, antiracism, and communication across disciplines, will be critical for people working in all areas of drug R&D, Bryant-Friedrich said. She described her experiences working with students from historically marginalized communities and said that some of these students have described higher education institutions as “breaking down their resilience.” Rather than acknowledging and embracing the culture and individuality of students, she said, higher education institutions try to shape students into a standard professional mold.

A workshop participant asked panelists to talk about existing efforts to build a more inclusive clinical trials workforce and promote clinical research as a career option to those in marginalized groups. Bryant-Friederich said that she is involved in two National Institutes of Health (NIH) programs that are specifically designed to bring historically marginalized students into the biomedical sciences. ReBUILDetroit (Building Infrastructure Leading to Diversity)¹ identifies students at the end of high school who have the interest and ability to perform well in biomedical sciences and gives them the support and resources necessary to succeed. The Initiative for Maximizing Student Development² is a similar program that operates at the graduate level. Each of these NIH-funded programs includes outreach to help ensure that the diversity of the Detroit community is reflected in the biomedical sciences. Bryant-Friedrich added that there are differences in exposure to math and science between students living in the city of Detroit and students living in higher-resourced areas outside of the city. Programs such as ReBUILDetroit seek to address some of these gaps by serving as a bridge to college for underserved students.

Joseph Menetski, the senior vice president at the Foundation for NIH, said that the inherent tension between the call for diverse and inclusive clinical trials and a shift in the field toward precision medicine has implications for the workforce. He contended that, by its nature, precision medicine, such as gene-based therapies, is designed for smaller, less diverse groups of people (e.g., individuals who have a particular genetic variation). Clinical trials to evaluate precision medicine interventions, by necessity, may not be very diverse or inclusive. At the same time, it will be important to ensure that personalized therapeutics are made available to a diverse patient population. Aravamudan suggested that both types of trials are critical. For example, if an important genetic variation is found—whether associated with a racial group or some other grouping—research should be done to assess how to best treat people with that variation. At the same time, researchers should look broadly at the patient population to ensure that communities are not being left behind. Several panelists suggested that workforce and training resources for researchers and other stakeholders should be prioritized to advance precision medicine and ensure equity.

Engaging a Community-Based Workforce

John Wigneswaran, the chief medical officer at Walmart, said that one of Walmart’s assets is that it has a workforce that is community based and

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¹ For more information, see http://rebuildetroit.org/ (accessed February 20, 2024).

² For more information, see https://www.nigms.nih.gov/training/IMSD (accessed February 20, 2024).

representative of the population it serves. Walmart has 5,000 pharmacies across the country; of these, 4,000 are located in underserved areas (Caley, 2021). Nine in ten people in America live within 10 miles of a Walmart, and there are tens of millions of people on Walmart’s pharmacy email list (Borfitz, 2022). The breadth and depth of Walmart’s connections with the community enables Walmart’s workers who are involved in health care (e.g., pharmacists) to connect with the population, hold honest conversations about participation in clinical trials, and engage with community members in a way they understand, Wigneswaran said. He went on to say that Walmart looks at clinical trials as a care option and a way of directly engaging patients.

Working Across Disciplines

Bryant-Friedrich and Butts said that the clinical trials enterprise should include interdisciplinary work that goes beyond already established fields, such as chemistry and biology, and bring together more disparate disciplines, including behavioral and natural sciences. This would necessitate broad training for professionals in every role and at every stage of clinical research, Monarez said. She said that the workforce should possess an understanding of the participants of the clinical trials as well as the necessary technical training to appropriately oversee trial design and implementation. Bryant-Friedrich added that it is critical for higher education institutions to prepare students with this type of training.

Individuals involved in clinical trials should be reflective of the population that would benefit from a given drug or device. At the same time, Monarez said, trial participants should not be included solely based on the appearance of diversity and equity. Attention should be paid to inclusion and equity in terms of the benefits of the trial, the affordability and accessibility of the product, and the use of the data that are generated. As an example, Monarez said that individuals who sit on an institutional review board (IRB) should have the skill sets and training necessary to understand the scientific and technical aspects of a study as well as the ethical, societal, and legal implications of a given study. Butts added that clinical trial participation takes substantial time and commitment, so it is important for IRBs to consider the differences across people and communities when it comes to assessing the potential burden and reasonableness of what researchers are asking participants.

Cultivating Communication Skills

Butts asked panelists to consider what new types of expertise and training might be required for preparing the R&D workforce of the future. Wigneswaran suggested that effective messaging and communication will be essential skills. For example, Walmart has an option for customers to opt in to receive messages about clinical trials. Wigneswaran emphasized that the language used in these messages is critical to how they are received. Using tools such as natural language processing to interpret insights and determine appropriate messaging will become increasingly important, he added. Bryant-Friderich reiterated her earlier point about the importance of humanizing data—populations, such as Walmart’s customers interested in clinical trials, should be viewed in the context of their lives, rather than as data points. Bryant-Friedrich added that it is important to understand and engage people at all levels of education and include those who may not trust the health care system. Butts said that this lesson was made clear during the COVID-19 pandemic when vaccines were available but many people chose not to get vaccinated. It is important to understand the context for a given community, to acknowledge and address their past experiences in health care, and to use appropriate messaging that engages them, Butts said. Aravamudan said that research can serve as a tool for working with communities and building trust. For example, a research institution can work with a given community to develop a partnership in which both the institution and the community benefit from data sharing. Bryant-Friederich added that concepts such as restorative justice can be useful in considering how to engage with communities, by helping to address past harms and building trust.

Supporting a Sustainable Workforce

Butts asked panelists to identify key considerations and guiding principles for enabling a more sustainable future clinical trials workforce. Monarez replied that there are core principles at ARPA-H which are geared toward sustainability and scalability. First, programs funded by ARPA-H must address ethical, legal, and societal implications as well as issues of accessibility and affordability. Monarez noted that far too often, medical innovations benefit those who already have access to high-quality health care. ARPA-H seeks to ensure that the programs it funds are designed with the broadest accessibility and affordability. In addition, she said, scalability and sustainability are “baked into” the program design. ARPA-H is not a long-term funder, so programs are required to have a plan for taking a product or technology to the next level and for scaling innovation in order to reach the broadest population. Ensuring sustain-

ability and scalability requires “choreography” with multiple moving pieces and stakeholders, Monarez said, but is important to ensure that resources are not invested in innovations that cannot go the distance. Wigneswaran said that sustainability is also important to Walmart and that the organization serves a gatekeeping function by choosing to be involved in projects that have broad applicability and make a difference in the populations it serves.

Another skill set that has become increasingly important, Monarez said, is the ability to execute and manage clinical trials. Given that there are a number of small and medium-sized enterprises (SMEs) developing drugs and devices, the executives of these entities may require additional resources to build their knowledge base and enhance their training in support of more inclusive and diverse clinical trials. She suggested that executive education and training would be beneficial for SMEs and the clinical trial enterprise as a whole. Similarly, Monarez suggested that individuals involved in clinical trial networks need ongoing training and opportunities to share best practices for conducting more inclusive and diverse clinical trials. She added that faculty and administrators who design and implement curricula should ensure that they are up to date on changes in the regulatory space to convey relevant and accurate information to students.

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