Yearly Archives: 2024

Sometimes in the realm of evolving clinical research regulations, the maxim about “be careful what you wish for” can more accurately be phrased as “be aware of it when you get what you asked for.” Such is the case with recently proposed U.S. Food and Drug Administration (FDA) guidance updating the agency’s expectations for the contents of informed consent forms for clinical trial participants, says an expert who will explain the history behind the updates and their ramifications for stakeholders at the ACRP 2025 conference in New Orleans in April. 

A scholarship powered by the long-distance cycling adventures of some of the ACRP Community’s greatest equity champions and their backers has gone the distance on the other side of the globe this year, resulting in a completed prostate cancer project for Esther Samuel in Nigeria, who was among the initial recipients of ACRP Access for Students to Clinical Research Training (ASCRT) program support.

Arriving on a desktop near you soon, just about everyone in the clinical research enterprise who remembers the last era of updates knows that something big is coming down the line in the form of the International Council for Harmonization’s (ICH’s) next iteration of its guidelines for Good Clinical Practice (GCP). It may be nothing but good news for some, it may mean dealing with a learning curve due to extra compliance expectations for others, it may call for overhauls of processes once taken for granted, but the many changes in the forthcoming ICH GCP E6(R3) can be expected to work their way into all levels of organizations and their workforces. 

The wisdom of generations before ours says that “a rising tide lifts all boats,” to which modern clinical research veterans might add, “building a sense of community among scattered clinical trial sites can help to keep all of the stakeholders in medical research afloat in trying times.” 

Among other related topics in her forthcoming ACRP 2025 presentation on “Women Leaders Breaking Barriers and Achieving Success in Clinical Research,” Jessica Fritter, DHSc, MACPR, ACRP-CP, at The Ohio State University, will explore the historical context of women in leadership roles as she works her way toward addressing the apparent gender disconnect that is specific to health-related professions.