Higher Education - Applied Clinical Trials

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Higher EducationConcerns are being put into action with the trend toward better investigator training.

Source: Applied Clinical Trials



Kerri Nelen
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.

Deeper understanding

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."

The pendulum swings

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."


Gaining Academic Ground
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.]


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