Development of a Clinical Trial Methodology and Appraisal Curriculum for Hematology Fellows

Background: The past few decades have seen dramatic clinical advances in benign and malignant hematology. From genomically-targeted diagnostics and therapeutics to novel cellular and immune-based therapies, scientific concepts move to investigational products with astonishing speed. In parallel, clinical trials have become more complex, reflecting both the increasing complexity of the clinical landscape as well as improvements in trial design and standards. To effectively practice in this environment, hematology fellows need to develop a functional understanding of clinical trial methodology and appraisal. However, whereas there are many educational materials focused on content knowledge of hematology topics, there is a paucity of formal resources for better understanding trial methodology. We report the development of a longitudinal, multimodal clinical trial methodology curriculum for hematology fellows grounded in Self-Determination Theory (SDT).

Methods: We developed a longitudinal clinical trial methodology curriculum for hematology fellows. The multimodal curriculum consists of both interactive didactic sessions as well as longitudinal integration of methodology teaching into the existing fellow-led journal club. Within the framework of SDT, the curriculum is designed to move fellows from stages of extrinsic motivation to understand and implement critical appraisal (e.g., avoidance of shame) to intrinsic motivation, i.e., integrating critical appraisal into one's professional identity and practice (Th.J. ten Cate et al., Medical Teacher 2011) Conceptually, this is effected by providing adequate content knowledge, a safe space to practice and explore difficult concepts, and serial reinforcement of both the cognitive and social nature of critical appraisal through fellow-led journal club. Progress will be assessed through the first 3 stages of the Kirkpatrick model: reaction, learning, behavior.

Results: The concept, teaching modalities, assessment schema and theoretical underpinnings were developed through the ASH MEI program over the 2022-2023 academic year. Iterative review of the course content and modalities occurred through both ASH MEI small group meetings throughout the year, as well as with the directors of the UW Madison Hematology/Oncology fellowship program. Three of the didactics focus on content knowledge, starting with general methodology principles (e.g., validity) before focusing on the hematology-specific challenges of implementing and balancing these principles in therapeutic trials (e.g., enrollment criteria, endpoint selection, etc.) The final didactic is a guided review of a cooperative group trial protocol by clinical trialists from UW Madison, focusing on practical aspects of trial design and implementation. The journal club curriculum includes a methodology rubric trainees can apply during the development of their journal club presentation, as well as a one-on-one debrief session with faculty after their presentation to discuss challenges. Evaluations throughout the curriculum include pre/post survey of learners' comfort and identification with critical appraisal, as well as pre/post knowledge assessment with multiple choice test at beginning and end of curriculum.

Conclusion: This curriculum is a proof-of-concept theory-based methodology curriculum for hematology/oncology fellows. The curriculum is being implemented in the first half of the 2023-24 academic year and will report out initial results by ASH 2023. If successful, this curriculum could potentially be expanded to a more extensive array of methodology topics within hematology/oncology and be applied on a larger scale.