Tufts Clinical and Translational Science Institute (Clinical Trial Design Labs Supplement)

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Project Summary Tufts Clinical Trial Design Labs are structured multi-stakeholder events that support development of innovative solutions to improve the design and impact of clinical trials. During the first year of our UM1 Clinical and Translational Science Award that starts May 1, 2023, we will host two Design Labs and develop a playbook of materials and training to support the dissemination of this approach. As with prior Design Labs led by the Tufts part of the Johns Hopkins-Tufts Trial Innovation Center (JHU-Tufts TIC), the Design Labs to be done under this supplement will be case-based and focused on development of innovative methodology to improve the design and implementation of clinical trials. We will work with the Trial Innovation Network (TIN) to put out a call for proposals, and the clinical trial proposals will be scored and carefully selected by the Design Lab team. The use cases that are successful will be those whose consideration will also provide generalizable information about innovative clinical trial designs. The Design Lab process begins with a series of detailed and interactive meetings that: help investigator teams consider the relevant stakeholders for their proposed trial; ensure that they think innovatively about the design options and opportunities; and hone the questions that they want to bring to the Design Lab event. The process culminates with an event that brings together a diverse group of stakeholders from across the biomedical spectrum and takes a systems-level approach to the proposal, focusing on health impact. A report is produced after the event to summarize themes and learnings from the day for the study team. In addition to the trial specific report, which will be confidential, the Tufts Design Lab team will work with the investigator team and the TIN to disseminate broader, generalizable learnings about innovative design methodology. The Design Lab program of work will continue to evolve with input and support from the TIN, targeting clinical trial roadblocks in innovative ways, and learning from case-based examples that bring together relevant stakeholders to discuss how to make scientific progress across the translational spectrum.