The Adaptive Designs Accelerating Promising Trials into Treatments (ADAPT-IT) project was a cooperative project involving the NIH common fund, the FDA, and the Neurological Emergencies Treatment Trials (NETT) network. An overview of the project is here ADAPT-IT overview. The overarching objectives of ADAPT-IT were to identify and quantitatively characterize the ACT methods of greatest potential value in confirmatory phase clinical trials, and to elicit and understand the enthusiasms and concerns of key stakeholders that influence their willingness to try these innovative strategies.
Our team developed 5 innovative adaptive trial designs. The ADAPT-IT team included clinicians planning trials (including the NETT Clinical Coordinating Center), biostatisticians from the Medical University of South Carolina (NETT Statistical and Data Management Center), biostatisticians from Berry Consultants, along with partners from the NIH and FDA.
In addition, we conducted a 2 day, interactive design symposium in 2013 called DESIGN-IT. The videos from the sessions are here.
This work was supported jointly by the National Institutes of Health Common Fund and the Food and Drug Administration, with funding administered by the National Institutes of Neurological Disorders and Stroke (NINDS) U01NS073476. In addition, the Neurological Emergencies Treatment Trials (NETT) Network Clinical Coordinating Center (U01NS056975) and Statistical and Data Management Center (U01NS059041) are funded by the NINDS. We specifically recognize the efforts of Dr. Robin Conwit and Dr. Scott Janis, from NINDS for their work with NETT and their assistance in facilitating this project.