At the podium, Elliott Antman, held aloft a tube containing a pinch of white powder. “This powder has never been given to human beings. We’re going to talk about how you conduct the experiments that will let you do the first-in-human trial.” He then lifted a vial of pills. “Tomorrow, we will learn how to take that drug and determine whether or not it’s better than our standard of care. And we’ll talk about how we determine whether or not it’s cost-effective to use this new drug.”
With that, Antman, director of the Harvard Catalyst Postgraduate Education Program in Clinical and Translational Science and a professor of medicine at Brigham and Women’s Hospital, opened the most recent session of Introduction to Clinical Investigation (ICI). This five-day course, developed by Harvard Catalyst, the Harvard Clinical and Translational Science Center, covers the fundamental principles of turning a bench-top discovery into a bedside intervention. Offered three times a year, ICI is tailored to early-career MDs and PhDs with an interest in general principles of clinical and translational (C/T) research, regardless of their medical or scientific specialty.
Combining interactive electronic and in-class “wiki group” discussions with workshops and lectures, Antman, James Ware, the education program’s associate director and the Frederick Mosteller professor of biostatistics at HSPH, and a team of instructors from HMS, HSPH, and Harvard-affiliated hospitals followed the white powder’s research journey to demonstrate basic C/T research concepts, including research design, research technologies and services, ethical and regulatory issues, community-based research, epidemiology, intellectual property, informatics, grant writing and data communication. Actors from the Derek Bok Center for Teaching and Learning put a human face on the challenges doctors face when recruiting patients into clinical trials and when young faculty approach potential mentors.
The March course featured a keynote lecture by BWH president Elizabeth Nabel, who was until recently director of the National Heart, Lung, and Blood Institute. Nabel spoke about the NIH Roadmap for Research and its exciting implications for clinical and translational investigators.
Laying a Path for EducationThe ICI course is just one of Harvard Catalyst’s signature efforts to pave a comprehensive educational and training pathway for C/T investigators at Harvard. “The career of the academic medical investigator is well-scripted through the end of the clinical fellowship,” said Antman, “but past that, there are no well-defined paths for young faculty to learn the skills needed to become successful.”
The pathway Antman and Ware envision starts with introductory courses like ICI and another Harvard Catalyst course, Intensive Training in Translational Medicine. From there, the path traverses advanced courses offered a la carte by the Harvard schools and affiliated hospitals and catalogued in Harvard Catalyst's Advanced Curriculum Compendium. The guideposts end with specialized training through master's programs and fellowships, which are available through HMS, HSPH and Harvard Catalyst.
The ICI’s place is to provide a survey of the skills and concepts at the heart of C/T research, compiling much of the training and experience that fellows and young faculty in the past might have picked up piecemeal.
Ware said, “Much as there is a large gap between the bench and bedside when it comes to new treatments, so there is a gap in training, education and guidance between the end of fellowship and the first independent grant. In laying down this pathway, we will help close that gap.”
The students came away with a new appreciation of what goes into clinical and translational research. “I knew so little to start,” one participant noted. “I learned a great deal and value both the resources mentioned and the sincere willingness of the faculty to guide us.”
