The scientific program for the 2023 Workshop will consist of four main formats to serve a variety of educational needs:
- Lecture Sessions are required sessions for all participants with lectures focused on fundamental topics in clinical trials that are applicable to all attendees. Approximately half of the didactic sessions incorporate audience response questions to facilitate interactivity and support learning. Past topics include: biomarkers, combination and multimodality trials, correlative studies, data collection and presentation, feasibility and reproducibility, imaging considerations, inclusivity, investigator responsibilities, multi-institutional trials, multimodality trials, navigating the regulatory process, NCI and other funding sources, patient accrual, patient-reported outcomes, phase I and II trial designs, patient-investigator role play of an informed consent discussion, special consideration in immunology, statistical design and considerations, and trial ethics and informed consent. Lecture topics are revised each year to incorporate advances in clinical oncology research and attendee needs.
- Protocol Development Group Sessions (PDGs) are small group sessions that guide each participant through the transformation of a protocol concept into a fully developed, IRB-ready clinical trial protocol with informed consent documents. These sessions are held each day of the Workshop and consist of 8-10 students led by 2 clinical faculty members, 1 biostatistician faculty member, and 1 patient advocate faculty member. The PDG sessions are intense, constructive, and highly interactive. Throughout the Workshop there are deadlines for deliverables, such as: (a) a formal concept sheet; (b) a statistical design section; (c) a draft protocol; (d) a patient informed consent form; and (e) a completed protocol suitable for submission to an IRB. Each document is reviewed and returned with in-person and written feedback from PDG mentors.
- Small Group Discussions are optional, discussion driven sessions of approximately 15-25 participants and faculty focused on more specific clinical research topics. Small Group Discussions cover a wide range of special topics such as patient reported outcomes and palliative care; selection of appropriate clinical trial endpoints; special populations; scientific writing, oral presentations, and grantsmanship; career counseling and interest sessions; and career interest groups.
- Personalized Mentoring Sessions provide time for one-on-one, individualized counseling and advice on protocol and career development.