A woman receives a vaccine.

PIs recognize need for greater diversity in trials, feel frustrated by limitations

By Nadine Spring, The Association of Clinical Research Professionals (ACRP)

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. Read more …