Because nothing stands still for very long in the clinical research enterprise and time is a precious commodity, rather than coming in the form of full-fledged, long-term programs focused on their needs, ongoing education for principal investigators (PIs) tasked with leading clinical trial teams often comes in other guises. These may include learning in an on-the-job manner, through structured (though perhaps scattered) courses, by attending sponsor/contract research organization–conducted trainings, or by completing online modules on specialized topics.
However, none of these options may be sufficient in isolation, according to a trio of experts who addressed how to keep PIs up to speed with the demands of their calling in the midst of an ever-changing clinical research landscape at the ACRP 2025 conference in New Orleans.
Presenting on “Principal Investigator Qualifications: Are Micro-Credentials Enough?” were Erika Stevens, MA, FACRP, Director of Clinical Research Experience and Faculty Lecturer, Rutgers Health; Anita Kablinger, MD, CPI, Professor, Academic Vice Chair, and Director of Clinical Research at the Department of Psychiatry and Behavioral Medicine, Virginia Tech Carilion School of Medicine, Virginia Tech Faculty of Health Sciences; and Nadina Jose, MD, FPCPM, Assistant Professor of Clinical Research Management at the School of Health Professions, Rutgers, The State University of New Jersey.
A micro-credential is a series of courses that culminate in a digital badge (online verified proof of competency) from an accredited educational provider, letting others know that the holder has proficiency in a subject area. Such evidence can be important in the context of clinical trials, considering how U.S. regulations indicate only that PIs “must be qualified by their training and experience to conduct clinical research,” without elaboration.
“There are currently a number of different opportunities for investigators or potential investigators to access information, training, education, etc. [about conducting clinical research],” Stevens said. “One of the things that’s not necessarily clear though is [the utility of] creating online training or digital badges or [attending conferences or focusing on competencies]. The challenge is, [do these options] necessarily increase the capability, the functionality, and the ability [of PIs] to actually implement the knowledge learned. Further, will a micro-credential for clinical research professionals, especially for PIs, afford opportunities for easy access to enhancing competency in conducting clinical trials?”
Clinical research training is not typically a part of medicine or medical training in general, Kablinger noted, and that raises the topic of certification for different clinical research roles, including the PI role.
“Without a mandate for certification in clinical research as a subspecialty from a regulatory agency or a standard that physicians can be held to, the [knowledge gap between standard physicians and PIs continues] to widen,” Jose said. “Hopefully by stirring up more conversation, we can make people more aware of the need to really create a universal standard for what it means to be a PI.”
Meanwhile, “competency” involves the knowledge, skills, and attitudes one brings to their workplace, Kablinger said. “We need to know that [PIs have] basic knowledge” for what they are doing, she added. “We have to see that [they can perform] certain behaviors or follow through and complete certain studies in certain ways. And you have to have the attitudes—leadership, communication—to be able to put it all together. Competency is the equivalent of all of those things.”
PIs need to go the extra mile to demonstrate their qualifications for clinical research to all stakeholders in the industry, Jose noted. “I hope that’s what micro-credentialing can do [for the field],” she said. “I think [PIs need step up] because the life of [their] patient is still in [their] hands, no matter what.”
Thus, the experts noted that fundamentals of online teaching and learning, coupled with adult learning methods and the industry’s continued reliance on a decentralized method of training, remain pivotal to assess PI learner capabilities.
Another PI-focused session at ACRP 2025, “Challenges and Solutions for Getting Physicians Involved in Clinical Trials,” was presented by Nancy Sacco, Vice President and Head of Clinical and Site Development Operations at SiteBridge Research Inc; Edwin Burkett, Chief Medical Officer at Alliance Medical Ministry; and Amir Herman, Medical Director at East Northport Medical Care. Recordings of both of these sessions—and many more from ACRP 2025—are available in the ACRP Course Catalog, where they can be found by selecting the “Recorded Conference” option and going to the “Full Program” bundle, or within separately themed bundles of fewer sessions. Costs for access to these replays will depend on the individual’s registration type (if any) for the original conference.
Reported by Gary Cramer