CTSI is piloting a new Clinical Trial Design Studio program that offers a dynamic, integrative, and intensive consultation service to improve the quality of investigator-initiated clinical trials. A Studio session provides a structured and collaborative roundtable discussion bringing together relevant trialists and other experts to help investigators that are designing a clinical trial, rather than having separate consultation for different aspects of the clinical trial design process. The Design Studio process is based on models from industry and academia that demonstrate that multidisciplinary content experts can increase research impact.
Eligibility: This initial pilot program is limited to faculty with UCSF appointments (including faculty at affiliate sites) designing clinical trials that involve human subjects. Ideal candidates for a Design Studio have a well-defined hypothesis and preliminary study outline and are in the pre-award stage of developing their trial proposal.
This pilot service is free and funded by the CTSI. We anticipate selecting up to two studies to participate in the pilot Design Studios consultation service in Fall 2022. Applications are accepted on a rolling basis until October 17.
Design Studio Format
A 90-minute consultation with a panel of three to five carefully selected experts from varied disciplines.
- Investigator presents brief summary. (10-15 minutes)
- Focused discussion with experts for three or four predetermined questions from the investigator. The conversation is moderated to maintain focus on problem-solving and the development of helpful solutions. (60-70 minutes)
- Moderator and panelists provide summarized comments. (10-15 minutes)
Following the session, the investigator receives a summary report and audio recording from the discussion for the investigator’s ongoing reference.
Examples of Topics that Might be Addressed in a Design Studio
- Adaptive designs, Bayesian designs, Adjustment for baseline characteristics; Blinding/masking
- Sample size calculations; Statistical Analysis Plan; DSMB; Exception from Informed Consent (EFIC studies)
- Trial Budgeting; Trial Implementation; Site Selection; Contracting; Data management
- Navigating FDA and regulatory requirements and resources at UCSF
- Recruitment (including recruitment methodology and recruitment of underrepresented populations)
- NIH Data sharing plan
