Signature Series speakers took on more of the clinical research enterprise’s “big picture” topics at ACRP 2025 on Saturday (April 26), focusing in the morning on the implications for clinical trials teams of the recently updated ICH E6(R3) Guideline for Good Clinical Practice (GCP) from the International Council for Harmonization, and in the afternoon on how seasoned professionals are enacting meaningful change in their organizations for the betterment of trial implementation and management.
Moderating on the topic of “Principles to Practice: An Understanding of the ICH E6(R3) Update’s Effect on Good Clinical Practice,” Jessica Fritter, DHSc, MACPR, ACRP-CP, Associate Clinical Professor at The Ohio State University, pointed to items found in ACRP’s Guidelines and Regulations Resource Center as a good starting point for understanding the differences between ICH E6(R2) and ICH E6(R3). Updated training reflecting the changes will be available from ACRP later this year.
Katherine Mary Marangio, Learning Program Consultant for the Paraxel Academy, characterized the revised guideline as not changing the previous version’s core principles, but having a greater focus on risks in trials and “how to adapt our processes for quality in every step for more efficient, patient-centered studies” featuring reduced complexity. “We need to be sure our teams are individually compliant in applying [GCP] in their situations,” she added, which means fostering a community of compliance but recognizing “there isn’t a one-size-fits-all training or communications strategy” for implementing the changes.
Leslie Sam, BA, CSSBB, CQIA, President of Leslie Sam and Associates, LLC, said her topline reaction to the E6(R3) updates are that they offer empowerment to clinical researchers to leverage the guideline’s tenets in service of trail participants. “A lot of the things that are described [in the revision], we are already doing,” she said. Importantly, “data governance now has a framework so that everyone can drive toward consistency and not everyone has” that one-size-fits-all approach to GCP. Earlier this year, she presented an ACRP Webinar about the guideline changes which is free for ACRP members and nonmembers if they are not seeking contact hours.
Saturday’s second Signature Series discussion delivered “Actionable Insights for Transforming the Clinical Research Enterprise.” With a kickoff by Jennifer Sheller, Senior Vice President, Head of Global Clinical Trial Operations, for Merck, the panelists were largely in consensus that, while new technology has improved the conduct of research in recent years, study sites still very much need and deserve tools capable of advancing patient safety and site efficiency, as well as support from sponsors for making full use of them. Their comments on this and various other timely issues were informed by recently released results from the first-ever ACRP workforce survey on the state of the clinical research enterprise, conducted in cooperation with Continuum Clinical and representing feedback from 735 respondents that often raised the question of whether the enterprise’s “glass is half full or half empty” on the challenges being faced by its stakeholders.
In addition to Sheller, the panel included Paul Ivsin, Executive Vice President, Trial Engagement Service, Continuum Clinical; Jeri Burr, MS, RN, PED-BC, CCRC, FACRP, Program Director, University of Utah; Edwina McNeill-Simaan, EdD, MSHS, CCRP, CCRC, Program Director, Vanderbilt University Medical Center; Nancy Sacco, PhD, Vice President Head of Clinical and Site Development Operations, SiteBridge Research Inc; and Pamela Tenaerts, MD, Chief Scientific Officer, Medable.
Among the other cutting-edge topics covered at the conference on Saturday, ACRP Board of Trustees member Noelle Gaskill, MBA, ACRP-CP, Vice President and General Manager for the Tempus TIME Network, and Karla Polk, Head of Pharma Operations for Tempus AI, spoke on “Novel Clinical Research Recruitment Models Developed in Partnership with Sites.” They highlighted some of the advantages and challenges to expedited study start-up, decentralized clinical trials, “just in time” practices, patient matching, and artificial intelligence–assisted patient recruitment.
Whichever path a site may take to achieve a study sponsor’s targets for trial enrollment, Gaskill and Polk noted that a successful model will reduce burdens on sites and participants, be based on input from investigators and site staff, and have qualities which are unique to the organizations involved due to their different characteristics.
Another session dealt with “Clinical Trial Diversity and Intersectionality: Looking at the Whole Patient,” with insights from Sylvia Baedorf Kassis, MPH, Program Director, Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard; Behtash Bahador, Director of Health Literacy, Center for Information and Study on Clinical Research Participation (CISCRP); Fenwick Eckhardt, Head of Diversity Strategy, Citeline; and Meghan McKenzie, MA, Director of Health Equity and Clinical Research, Genentech’s Chief Diversity Office.
Resources pointed to by the panelists included:
The Diversity Convergence Project: Toward a National Action Plan for Achieving Diversity in Clinical Trials from the MRCT Center, the Milken Institute, and the Clinical Trials Transformation Initiative
MRCT Center Model Diversity Action Plan
The MRCT Center Clinical Research Glossary
Project Equity on diversity plans in oncology from the U.S. Food and Drug Administration’s Oncology Center of Excellence
A Sexual Orientation and Gender Identity (SOGI) tool geared toward completion of electronic case report forms from the Clinical Data Interchange Standards Consortium
Professional Services available to researchers from CISCRP
Reported by Gary Cramer
