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Applied Clinical Trials
Concerns are being put into action with the trend toward better investigator training.
Alot can change in 15 years. Consider how Edwin C. Cadman, MD, described the scene at Academic Medical Centers (AMCs) in a 1994 article: "[There's a] prevailing attitude that patient-related research is easy and can be accomplished at night or on the weekends after spending 60 hours caring for patients and teaching."1
Cadman, whose long career included serving as chief of staff and senior vice president for medical affairs at Yale New Haven Hospital, displays a deep concern—echoed by others—for the lack of investigator training in the methods of patient-oriented research. An absence of which, he attests, often leaves faculty "ill prepared to conduct scientifically credible research."1
Fast forward to a new century, and Cadman's remark about how many in the early 90s viewed patient-related research elicits responses like "that's crazy" from some who now call AMCs their work place. Apparently, there's a new prevailing attitude not only in regard to research but also to training.
Conversations with those in academia today portray AMCs as institutions well aware of the need for trained investigators as well as staff—from nurses to administrative personnel. And many of these institutions are taking it beyond the nuts and bolts of safety and good clinical practice to the A, B, Cs of clinical and translational research via a degree.
But degree programs aren't new. "There were programs designed for physicians, but it's evolving into a much more structured program," said Erin Haynes, DrPH, assistant professor and director of the clinical and translational research program at the University of Cincinnati (UC). "For instance, AMCs may have had programs in epidemiology, but [they're] changing into a more tailored program."
Haynes' own university, an AMC, is one example of the kind of change she's talking about. UC only recently started offering a master's program in clinical and translational research (it's still awaiting approval by the Ohio Board of Regents). Previously, UC physicians would earn an MS in epidemiology. With the advent of the master's program, however, they can receive comprehensive training in clinical trials, molecular epidemiology, translational research, and clinical effectiveness.
Another AMC that's tailoring their research training for physicians is Robert Wood Johnson, one of the hospitals that make up the University of Medicine and Dentistry in New Jersey (UMDNJ). Next fall RWJ, as its known, will launch a masters of science in clinical and translational science. The program will include classes on clinical trial design, biostatistics, ethics, regulations, and grant writing and funding.
The impetus behind the creation of RWJ's new program is the National Institutes of Health (NIH) and its Clinical Trials and Science Awards (CTSA), says Diane Ambrose, PhD, Director of special projects in the office of research and sponsored programs at UMDNJ-RWJ Medical School.
"We want to submit a proposal [for] the award and to do that we have to build training programs, that's a requirement [of the grant]," she explained, adding that "it's been pretty clear this is the way academic medicine is going, that the NIH wants to see more therapies and more diagnostics produced for their dollar."
Although NIH training grants for academic physicians date back to the 50s, it was the institute's 1997 Nathan Panel—which recommended establishing training and career development programs—that Stephen Heinig of the American Association of Medical Colleges (AAMC) calls a "landmark."
The result was the Mentored Patient-Oriented Research Career Development Awards (K23), the Midcareer Investigator Award in Patient-Oriented Research (K24), and the Clinical Research Curriculum Awards (K30). [All three have since been merged into the CTSA to form a more cohesive and larger clinical research training program.]
Gaining Academic Ground
Patient-oriented research received another boost in the early 2000s with the development of NIH's Roadmap for Medical Research. Among its goals: reengineer the clinical research enterprise by attracting more investigators, protecting their time, providing mentoring, and breaking long-standing barriers between the laboratory and the bedside. Soon after NIH launched the CTSA.
From the looks of things, all signs—and almost all interviewees—point to NIH for the recent push to strengthen training for academic investigators. But to give them all the credit would be telling only part of the story. That's according to both Applied Clinical Trials' Columnist Ken Getz and AAMC's Heinig. In fact Getz, who is also a research fellow at Tufts CSDD and chairman of CISCRP, says crediting NIH for the push for better training is putting the cart before the horse.
"I think it came more as a result of some of the very highly publicized and tragic patient deaths in the late 90s that led to a whole host of reform at IRBs and efforts to create a higher level of accountability," said Getz. "If anything, it was some of those initiatives that prompted the creation of the Roadmap and the Critical Path."
And while Heinig, lead science policy analyst at AAMC, credits the NIH's support and commitment for "creating a lot of the impetus for the new training," he points out that a number of schools—like Pitt, Duke, and the University of North Carolina—had already begun implementing stronger training for physicians.
These institutions foresaw what NIH would eventually describe in their Roadmap: the need to improve pathways for training physicians in patient-oriented research since none existed—most investigators learned on the job—and the need to catch up with laboratory science. "There were all these new advances out of the lab that seemed to be begging for investigation in human subjects," explained Heinig.
So, where does pharma stand on all this? George Betts, MBA, head of U.S. medical operations at Novartis, says pharmaceutical companies prefer to work with trained investigators. It's their ability to properly execute the clinical study and keep patients safe that pharma finds most appealing.
As for whether training is one of their selection criteria, Getz doesn't think so. "It's going to be an additional credential," he says, "after they've established the experience level and whether they have a prior relationship with the investigator."
At least two drug companies, however, are participating in training. A grant from Pfizer and Merck is funding the Clinical Investigator Training Program, a cooperative effort between Boston's Beth Israel Deaconess Medical Center and the Harvard–MIT Division of Health Sciences and Technology. The program's Web site describes its goal as "to train physicians in the techniques and processes in patient-oriented research."
The idea that physicians need tailored training in clinical research is actually spreading outside the walls of AMCs. The AAMC's Clinical Research Task Force II (CRTF II), which Heinig worked on, recommends that "every future physician should receive a thorough education in the basic principles of translational and clinical research, both in medical school and during residency training."2
This, concludes the CRTF II, would among other things equip all physicians—including those who eventually work in private practice—with the ability to effectively communicate with patients about clinical research and, thus, participation in trials. With data showing that most study volunteers find out about clinical trials from their doctor, one can argue that if all physicians receive solid training in clinical research then every patient will truly represent a potential trial participant.
Kerri Nelen is managing editor of Applied Clinical Trials, email: email@example.com.
1. E. Cadman, "The Academic Physician-Investigator: A Crisis Not to be Ignored," Annals of Internal Medicine, 120 (5) (1994).
2. H.B. Dickler, D. Korn, S.G. Gabbe, "Promoting Translational and Clinical Science: The Critical Role of Medical Schools and Teaching Hospitals," PLoS Medicine, 3 (9) (2006)