Among many other topics, speakers at this weekend’s ACRP 2023 gathering in Dallas, Texas, are sharing insights on the importance of building quality into clinical trials and increasing diversity among the staff and patients at the study site level.
Discussing the modernization of clinical trials in light of the pandemic and even larger, ongoing trends, David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, on Saturday (April 29) said, “It’s a global environment…that gets cripplingly complicated…[and] that is evolving all the time. What is ‘true’ today may not be true tomorrow. …You need to be able to continually remind yourself that you don’t know everything.”
However, in the quest for the “North Star” of quality in clinical research conduct, Burrow urged his audience to appreciate the tenets of the Quality by Design concept, which he said, at its heart for the profession, concerns what “we really need to get right to ensure the reliability of [study] results and patient protection.”
There’s a real business case to be made for the good that will result from embracing the idea that “we can build quality into clinical trials rather than inspecting it in,” Burrow added. “At the trial level, the protocol is the blueprint for quality. We need trials that are fit-for-purpose, using Quality by Design” from the start.
Later in the day, Demi MacLennan, MS, CCRA, ACRP-PM, Project Manager, Labcorp Drug Development, shared highlights from a recent survey she conducted as a graduate student on site practices and perspectives for improving diversity in trials.
Among other insights MacLennan noted from 149 responses to her survey—mostly from white/non-Hispanic clinical research coordinators—was the fact that about 41% of the respondents’ sites had implemented free or subsidized transportation to the site for patients as a way to improve diversity, but about 81% of them considered the practice of moderate or greater significance in terms of its potential impact.
Joining MacLennan in discussing trends in diversity issues related to clinical research were Carolynn Jones, DNP, MSPH, RN, FAAN, Professor of Clinical Nursing and Director of the Master of Clinical Research at The Ohio State University, College of Nursing, and Jennifer Plahovinsak, MS, DABT, Director, Master of Science Translational Pharmacology Program, The Ohio State University.
Author: Gary Cramer