The JHU-Tufts Trial Innovation Center is looking for investigators who are interested in pursuing innovative clinical trial designs to participate in a Design Lab. The Design Lab will explore approaches to the design and implementation of clinical trials that integrate efficacy and effectiveness using E2E or EE2.
Efficacy to Effectiveness (E2E) trials begin with an efficacy trial that expands its eligibility and endpoints while the drug is under regulatory review. Efficacy and Effectivenss Too (EE2) trials incorporate both efficacy and effectiveness components into a single trial, with a study sample that includes a cohort to address efficacy as well as a wider range of patients to test effectiveness.
The Design Lab will be organized according to the needs of the project being discussed. It may be a half or full day session and will involve a presentation by the investigator and a robust multi-stakeholder discussion. This is a great opportunity for investigators who are considering integrating efficacy and effectiveness in an innovative trial design.
To find out more information, or to receive a copy of the brief, one-page application form, please contact Marisha Palm, PhD, Project Director, Tufts Medical Center at email@example.com.
The submission deadline is December 10th, 2018.