August 3, 2017—The Trial Innovation Network (TIN) is now offering researchers two new opportunities in Efficacy to Effectiveness (E2E) trial design. Through the E2E approach, an effectiveness trial would commence seamlessly upon completion of the efficacy trial. E2E trials are prospectively designed to address the effectiveness and safety gaps that often occur in standard randomized controlled trials, and offer an opportunity for improved understanding of how a treatment will work in more usual real-world clinical settings. Explore the following new E2E opportunities to help improve your research:
E2E Design Lab in March 2018—The MIT NEWDIGS program and the JHU-Tufts Trial Innovation Center are hosting a two-day E2E Design Lab in March, 2018. This interactive multi-stakeholder event will provide a venue to discuss the considerations and challenges of designing a Phase 2 or Phase 3 E2E multi-site clinical trial that supports the generation of robust efficacy and effectiveness data. More information on how to participate. Registration deadline is Sept. 15, 2017
E2E Consultations—Applications are being sought by the Trial Innovation Center for E2E consultations, which offer a dedicated, protocol-specific approach to E2E trial design, focusing on the selection of suitable efficacy and effectiveness endpoints, advice on the statistical analysis plan, and the role of the DSMB in transitioning from the efficacy to effectiveness phase. Submit a request for a consultation.
For more information, please contact JHU-Tufts Trial Innovation Center Project Lead Sheeona Gorman, PhD.
More information about the TIN initiative and the TIN Hub Liaison Team at UC San Diego.