5

Envisioning the Future Landscape

In this session, workshop participants broke into small groups to discuss a particular role or discipline, identify challenges in this area, and consider practical approaches for making progress. After the workshop participants reconvened, a representative from each group briefly summarized the group discussion and key points. Groups were given the following questions to guide conversation:

• What is the anticipated capability and capacity for this role/discipline to meet the needs of a 2030 clinical trials enterprise?
• What elements/programs/policies should be put in place to support this career path or area in a way that is more person-centered and inclusive?
• What key elements or guiding principles should be considered to sustainably support/enable this career path or area?
• What are one to three short-term (i.e., within the next 5 years), tangible, and measurable milestones for assessing progress toward that goal?

DISCIPLINE: PRECISION MEDICINE

A common definition for “precision medicine” is needed, as it currently means different things to different people, Watanabe said. People on the front line who are engaging with communities need to be informed and trained to convey accurate messaging to the public. Watanabe asserted that precision medicine needs to be a field that will benefit all, not just “two people in the United States that are very wealthy.” To ensure that precision medicine is affordable, accessible, and beneficial for all, Watanabe stressed that the field needs to be “more pragmatic.” Furthermore, precision medicine needs to be a “team sport” in which multiple disciplines are engaged and data are quickly evaluated and shared. Currently, many of the efforts in precision medicine are happening in silos, with little awareness of what others are doing. Watanabe called for these silos to be broken down to create a more harmonized and coordinated movement toward precision medicine. Additionally, Watanabe said, there is a need to develop metrics to assess progress on including diverse populations in precision medicine efforts, and mechanisms for holding people accountable to these goals. For example, funding could be tied to meeting milestones related to inclusive research.

DISCIPLINE: AI/MACHINE LEARNING

It is critical that people working in artificial intelligence (AI) be able to work in cross-disciplinary teams that communicate and value other

perspectives and expertise, said Stephanie Kraft, an assistant professor of pediatrics at the University of Washington School of Medicine and the director of research in the Treuman Katz Center for Pediatric Bioethics and Palliative Care at Seattle Children’s Research Institute. According to Kraft, one approach for facilitating effective cross-disciplinary work is to conduct trainings for people working in data science so that they understand the biases embedded in datasets and can recognize the “lived experience of the people behind the data.” Professionals working in data science need the tools to interpret data and use data in ways that benefit the entire population, she said. In addition, Kraft contended that scientists who are not data experts need cross-training in AI methods to understand the systems and processes. Kraft reported that participants developed several ideas for potential programs that would help data scientists and other scientists work effectively together, including:

• Using case examples of datasets that are less biased to demonstrate the process and the teamwork that are required to create these datasets.
• Creating accreditation programs or required AI courses that incorporate data science with social science issues (e.g., bias).
• Ensuring that people overseeing research (e.g., institutional review boards, the U.S. Food and Drug Administration [FDA]) have appropriate training and understanding of AI.

To counter bias in data and AI, Kraft said, it will be necessary to generate better data; “the data that we generate is what will go into the algorithms that we create in the future.” Kraft concluded that generating better data will require a workforce that is engaged with community and can do the work to ensure that the data reflect the lived experiences of community members.

ROLE: STUDY COORDINATOR

Benjamin Wilfond, a professor in the divisions of bioethics and palliative care and of pulmonary and sleep medicine in the Department of Pediatrics at the University of Washington School of Medicine, said that he had co-authored a paper 20 years ago about the role of the study coordinator; it was called “The Invisible Hand of Clinical Research” (Davis et al., 2002). The breakout group’s discussion reflected the challenge and importance of making this invisible hand visible, he said. Research coordinators are essential for both the operation of the trial and the approach for reaching out to potential participants. Much like this workshop is focusing on the role of physicians and clinical researchers, he said, there

needs to be a similar focus on the role of research coordinators. There is a lack of data about the clinical research coordinator workforce, including its diversity. In order to make improvements, Wilfond said, it will be essential to get more data to understand the workforce and its challenges. Wilfond reported that one major challenge discussed by the breakout group was getting people into the field and trained. Many people do not know that the role of research coordinator even exists, Wilfond said, as science, technology, engineering, and mathematics outreach programs generally do not include clinical research or research coordination as fields. Furthermore, Wilfond commented on the issue that research coordinators get experience on the job rather than through a training program but that clinical trials usually want to hire a coordinator who already has experience. Wilfond insisted that there is a need for funding to ensure that programs exist to train and mentor coordinators to do their jobs effectively. Finally, Wilfond said that retention is a challenge among research coordinators as there is often no sustainable career path for people to feel accomplished and recognized.

ROLE: INVESTIGATOR PHYSICIAN

The number of investigator physicians has been in decline over the last couple of decades, and the proportion of individuals from marginalized backgrounds entering physician science has been “even more strained,” said Dowin Boatright, the vice chair of research, emergency medicine at New York University Grossman School of Medicine. The current system of institutions and funders does not seem to truly value diversity among physician scientists, he said. Boatright reported that participants discussed a number of tangible interventions, including:

• Requiring applicants for funding to demonstrate a plan for improving diversity or equity;
• Increasing training opportunities for professionals to enhance their understanding and commitment to diversity and equity;
• Developing metrics to hold institutions accountable for engaging in community partnerships; and
• Making changes to the promotion structure to incentivize and reward work while promoting health equity.

DISCIPLINE: COMMUNITY ENGAGEMENT

There needs to be both a philosophical and structural change to how community engagement is viewed, said Arch Mainous, a professor and the vice chair of research in community health and family medicine at the

University of Florida. Investigators and recruitment coordinators need training in community engagement to recognize and value community knowledge, he said. He further stated that funders need to think about community engagement from the beginning and to make the community and its needs foundational to the clinical trial. While FDA and the National Institutes of Health (NIH) both emphasize the need for diverse populations in clinical trials, relationships with diverse communities need to be built at the preclinical stage, Mainous said, rather than waiting until a drug is ready and the sponsor needs a community to test it on. To do this, Mainous said, a toolkit for community engagement co-designed by community members should be used by investigators and recruitment coordinators. Mainous reported that participants recognized three short-term milestones in making progress in community engagement:

• Funding of foundational programs for community engagement and training;
• Creating a pathway for diverse students to participate in the clinical trials workforce with a focus on opportunities for community engagement; and
• Getting mission alignment within trials and research to link back to community partnerships.

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