PIs Recognize Need for Greater Diversity in Trials, Feel Frustrated by Limitations

Nadine H. Spring, PhD, CCRC, Director of Operations, SpringWell360 LLC

Nadine H. Spring, PhD, CCRC, Director of Operations, SpringWell360 LLC

Principal investigators (PIs) interviewed for a recent academic dissertation recognized the need for greater diversity among participants in the clinical trials they run but are frustrated that the inclusion/exclusion criteria handed to them by sponsors often don’t match the real-life situations of the average patient in their practice with the condition of interest. These PIs also indicated that the field of clinical research itself isn’t diverse or representative of the population served.

In the forthcoming August issue of ACRP’s Clinical Researcher journal, these and other findings are detailed in a peer-reviewed article on “Perspectives from Principal Investigators on Improving Diversity Among Clinical Research Participants” by Nadine H. Spring, PhD, CCRC, Jeanne Connors, PhD, Michael Schwab, PhD, and David O. Anderson, PhD, all of whom are connected to Walden University. The article is based on a doctoral dissertation by Spring, who studied at Walden and is Director of Operations at SpringWell360 LLC.

The 15 PIs who participated in the study had an average of nine years of experience, and at least two years of experience conducting clinical trials in the United States. These PIs had experience in academia, industry, or government agencies with medicines and devices. Experience in any of the four phases of clinical trials was considered.

Spring said that respondents were prompted to share what attracted them to serve as a PI on clinical research studies. “Serving as a PI can be a challenging role,” she noted. “Respondents shared that they enjoyed the innovative components and the medical aspects of being involved in clinical research studies. They enjoyed being a part of the process to help their patients and to bring new therapies to the market. [But they feel limited by how] the eligibility criteria for some clinical trials can be so strict that it is difficult to get the average patient with the condition into the study.”

Clinical trials play a crucial role in making new medical treatments and devices available, the authors explain in the article. “However,” they write, “historically, these trials have lacked diversity in participant representation, posing challenges in determining the safety and efficacy of treatments for specific populations. This qualitative phenomenological study explored the experiences of clinical research [PIs] in addressing diversity in clinical trials. Participants, recruited through social media and professional networks, shared their insights through interviews. Thematic analysis revealed several emergent themes, including passion for clinical trials, increased awareness of the importance of diversity in clinical trials over time, frustration with eligibility criteria, recognition of the need for diversity among staff, awareness of barriers to diversity, concerns about the lack of formal training, and optimism for future strategies and solutions.”

The authors also state that “the study’s findings have implications for social change by guiding efforts to attract underrepresented minorities to participate in clinical trials, ultimately promoting diversity, reducing health disparities, and improving health equity.”

Other articles coming up in the August issue of Clinical Researcher include a peer-reviewed examination of “Possibilities and Challenges for Digital Medicine in Oncology Clinical Trials,” a special feature on “Career Navigation in Contract Research Organizations: A Vignette,” and columns on “Ethical Considerations for Clinical Trials of Psychedelics,” “Clinical Trials in Dravet Syndrome: Opportunities, Challenges, and Collaborative Solutions,” “What the FDA’s Final Guidance on Covariates Means for Fighting the Placebo Response in RCTs,” “An Adoption and Change Management Guide for Sites Implementing New Study Technologies,” “Data Integrity in Pharmaceuticals: Empowering Trustworthy Decisions from Source to Success via Registration Dossier,” and more.

Edited by Gary Cramer