Introduction to Clinical Investigation
- Introduction to Clinical Investigation is tailored to early-career MDs and PhDs with an interest in general principles of clinical and translational research, regardless of their medical or scientific specialty.
- This five-day course, which covers the fundamental principles of turning a research discovery into an intervention, is an immersion in clinical investigation, exposing participants to a range of expertise, skills, and case studies.
Introducing the session on statistical reasoning, James Ware describes working over the weekend to help a researcher with his vitamin D study. "As a clinical investigator, you want to make friends with a statistician," he said on the first day of Introduction to Clinical Investigation (ICI) in October, 2012. "One reason is that you need statistical expertise to write a strong study design or to write a competitive grant. But also, I've learned that statisticians are a terrific audience for investigators who are working through a research question."
James Ware, PhD, Frederick Mosteller Professor of Biostatistics at Harvard T.H. Chan School of Public Health and associate dean of clinical and translational research at Harvard Catalyst, is a co-developer of the course and one of dozens of presenters who have shared their expertise in this course since its inception in 2009. Offered twice a year through Harvard Catalyst's Postgraduate Education in C/T Science Program, up to 110 participants typically attend each course.
Learning 'Team Science'
Through a mix of presentations and group discussions, a team of instructors from HMS, Harvard T.H. Chan School of Public Health, and Harvard-affiliated hospitals demonstrate basic C/T research concepts, including:
- research design
- research technologies and services
- ethical and regulatory issues
- qualitative, mixed methods, and community-based participatory research
- intellectual property
- grant writing
- data communication
As students review the material, ask questions, and work in teams through the session workshops, they learn that some of the most challenging medical issues can be solved through the collective wisdom of team collaboration.
One of Harvard Catalyst's 13 Courses
A popular course among multiple offerings each year, the ICI course has provided a foundational educational and training pathway for C/T investigators at Harvard. "ICI provides a unique and invaluable experience to anyone considering a career in clinical and translational research," says Elliott Antman, MD, director of the Harvard Catalyst Postgraduate Education Program and a professor of medicine at Brigham and Women's Hospital. "The course demonstrates how all the fundamental pieces of C/T investigation fit together. Participants will experience a wonderful mix of didactic lectures, workshops, and opportunities to collaborate. It is the perfect launch into the more specialized courses the Harvard Catalyst Postgraduate Education Program has to offer."
After this introductory immersion, students move on to take other courses in the program, including Introduction to Translational Medicine, Leadership Strategies for the Researcher, and Medical Device Development, among others.
Providing a Roadmap
As researchers consider their next course, they're also putting what they've learned into immediate practice, as Tanya Laidlaw, MD, did. After completing ICI, Laidlaw designed a clinical trial which then led to successful NIH funding via a K23 grant. An assistant professor of medicine at HMS and director of translational medicine in the division of allergy/immunology at Brigham and Women's Hospital, Laidlaw enrolled to complement her laboratory-based studies with additional clinical research skills. She says she appreciated learning about creating consent forms and conducting IRB submissions, and especially the discussions on ethics. "Though I considered myself to already be experienced in the area of clinical research, I was struck by how much of the interactive discussion of the ethics of human investigation was eye-opening and new to me."
Mary Lou Jackson, MD, director of vision rehabilitation at Massachusetts Eye & Ear, decided to take the course to gain a general introduction to research and to learn more about the resources in the Harvard community. Specifically, she appreciated the overview on biostatistics, regulatory knowledge lecture, and the Bok Players theatrical session. "I think the course encouraged me to continue to take other Harvard Catalyst courses, as this one was very informative," she says. "It is a good base prior to taking other courses."
Fostering an Academic Career
For those seriously considering a future in academia, the course can also help shape plans and identify potential challenges to this path. Clifford Gimenez, MD, wanted to learn more about clinical research as he pursues an academic career with a mix of patient care, research, and student supervision activities. A postdoctoral clinical fellow in psychosomatic medicine in the department of psychiatry at Beth Israel Medical Center in New York, NY, Gimenez found that in addition to the helpful content, the speakers and presenters were highly organized and the classroom environment friendly and interactive, ultimately helping him clarify areas of concern in his planned career strategy.
Vishal Vaidya, PhD, participated in an early iteration of the course, when translational research was still a new term to investigators. Now an assistant professor of medicine and environmental health at HMS, Harvard T.H. Chan School of Public Health, and BWH, he had just begun an independent academic career as a PhD scientist in a clinical division when he attended ICI. "It was very clear that a major focus in my laboratory would be to identify biomarkers using animal models, evaluate them in human samples, and then come back to animal models to understand the mechanistic basis of their differential expression as it relates to the disease pathogenesis," says Vaidya. "Harvard Catalyst was the organization to clearly define this research as 'translational research.'" After reading the agenda of the first ICI course offering, he became intrigued by the key components, including clinical trial design, biostatistics, epidemiology, and genetics, and signed up for the next offering. "I really saw an opportunity to take a 20,000-feet view of my own research and think about how it fits in the global scheme of translational science -- and how, ultimately, it would benefit patients."
What Vaidya took away from the course informs his career to this day: knowledge about clinical design strategies "right from the gold standard," which encompass everything from double-blind, randomized controlled trials to the intricacies of adaptive clinical trial design using case studies and examples. "This was a complete eye opener for me in terms of understanding T2 and T3 research," he says. He also benefitted from the session "How to Give a Scientific Presentation." "Usually such lectures are boring and one always assumes 'I know how to present,' but this lecture was one of the best, and I certainly have made changes in my presentation style after that talk."
Connecting with a Vibrant Research Community
One of the main takeaways for Vaidya was the opportunity to stay connected with a multidisciplinary translational research community through Harvard Catalyst. "When starting a career in the Longwood medical area, one often gets lost among more than 5000 faculty members. I later received a Harvard Catalyst pilot grant, attended the first iteration of the Leadership Strategies for the Researcher course, and began presenting in the Introduction to Translational Medicine course, which I continue to do today." In addition, Vaidya is the director of the course Understanding Biomarker Science. "I try to provide the same sense of community-building in this course so students not only get exposed to the nuances of translational biomarker research but also have a network of scientists with whom they can discuss advancing science and their careers."