Washington University School of Medicine in St. Louis has established a successful model for training future clinical trial investigators through their comprehensive fellowship education program, addressing a critical gap in standardized clinical trial training for oncology fellows.
Program Structure and Implementation
The program, initiated in 2002, requires fellows to develop at least one prospective investigator-initiated clinical study under mentor guidance. Fellows begin by identifying mentors within the first two months, reviewing potential projects over six months, and drafting letters of intent before their second year. The curriculum has expanded to include a clinical trials boot camp lecture series covering trial phases, development processes, and diversity considerations in research.
"Clinical trial development and methodology education for fellows varies widely among programs," explains Dr. Christine Auberle, cochief fellow of hematology and oncology at Washington University School of Medicine. "Clinical trials are important to what we do in oncology; this is how we get new drugs, treatments, and standards of care."
Impressive Outcomes and Impact
A retrospective analysis from 2002 to 2023 revealed remarkable success metrics:
- 79% of participating fellows received institutional review board approval
- 60 out of 118 fellows published their studies
- 45% of published fellows were first authors
- 38% of publications appeared in journals with impact factors above 10
- Median time to institutional review board approval was 21 months
- Median time to first patient enrollment was 24 months
The program demonstrated a significant correlation between institutional review board approval and academic career placement, with an odds ratio of 4.96 (95% CI, 1.54-15.98; P = .007).
Balanced Research Focus
The program maintains a balanced approach across oncology subspecialties, with projects nearly evenly split between solid tumor oncology (60 studies) and classical and malignant hematology (58 studies). This distribution ensures comprehensive training across the field's major domains.
Future Directions and Expansion
The success of the program has sparked interest in expansion beyond hematology-oncology. "We would love to expand to other hematology and oncology programs," says Dr. Auberle. The institution is exploring opportunities to extend the model to other medical specialties, including infectious disease and rheumatology.
The program's structured approach to clinical trial education, combined with mentorship and hands-on experience, provides a valuable blueprint for other institutions seeking to enhance their fellowship training programs and develop the next generation of clinical investigators.
