By Neil Goldenberg, MD, PhD, The Children’s Hospital, Aurora, CO

2008-12-07

How does one train the next generation of clinical investigators? Not long ago, this question was largely moot — training as such did not exist. Rather, clinical investigation historically was a self-taught, experiential art. In the last decade, however, curricula to provide formal education in this area, including PhD tracks in clinical investigation within a graduate program in clinical science, have become increasingly common. Most recently, education and training in clinical trials design and implementation have even been encouraged by the National Institutes of Health (NIH) Clinical and Translational Science Awards program. However, it is also becoming increasingly recognized that didactic approaches alone for disciplines such as research methodology, epidemiology, and biostatistics are insufficient to prepare one for a career in clinical research. After all, clinical research, like clinical medicine, must be practiced, not just studied. This appreciation has led to a renewed call for hands-on, applied learning for future and early-stage clinical investigators. For the past six years, the ASH Clinical Research Training Institute (CRTI) has provided a unique and highly effective model for contributing to this mission.

The CRTI is an intensive and highly successful, weeklong, annual program that brings together the most promising fellows and early junior faculty in pediatric and adult hematology, oncology, and bone marrow transplantation in the United States and Canada with renowned faculty experts and mentors, in order to provide education and direct mentorship to future leaders in clinical and translational research. Frequent hands-on, small-group discussions aimed at serially refining trainee proposals for interventional trials and observational studies are complemented by interactive educational sessions on aspects of study design and analysis, translational scientific approaches for the clinical investigator, grantsmanship, and career development. These activities are interspersed with career retrospectives by leaders in clinical and translational research in benign and malignant hematology. The result, with respect to the protocol proposals, is a dynamic process of revision and optimization of study design that is not unlike the early work of a steering committee on a trial.

This year’s CRTI mentorship team included a mix of more seasoned physician-scientist-educators and young leaders. Trainees represented institutions from Johns Hopkins to the University of Pittsburgh, Stanford, and the University of Calgary, with diverse study proposals including a cohort study evaluating the prognostic significance of antiphospholipid antibodies in women of childbearing potential, a phase II trial of the addition of gemtuzumab, background therapy for non-M3 acute myelogenous leukemia in the elderly, a phase I study of high-dose lenalidomide during autologous stem cell transplantation for relapsed multiple myeloma, and an investigation of the impact of pharmacogenomics and routine vitamin K supplementation on INR stability in children with venous thromboembolism.  

I was fortunate to participate as a trainee in the inaugural CRTI, led by Drs. Jim George and Beverly Mitchell, and to be able to return to CRTI this past summer to contribute as a junior mentor. A number of changes have occurred since 2003; while its pace is still quite intensive, enhancements have been made in the level of NIH representation, the number of skilled biostatisticians providing hands-on expertise, and the continuity in small-group faculty mentorship. And yet, what is arguably every bit as important as the training of tomorrow’s clinical investigators — the unstructured interaction, career guidance, exchange of ideas, and networking that develops among mentors and trainees — continues to be a vibrant part of the CRTI experience. In several instances, the extramural mentorship and collaboration that continues after CRTI will build the foundation for future collaborative studies in the field.

Applications will be available on January 1, 2009, and must be submitted electronically to training@hematology.org by March 31, 2009.

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