High-Impact Trials Center: Collaborative Opportunities Component

University Of Alabama At Birmingham, Birmingham AL

Investigators

Linked publications & trials

Abstract

PROJECT SUMMARY The primary goal of the Collaborative Opportunities Component (Collab-C) of this National Resource Center, the High-Impact Trials Center (HITC), is to provide research advice and, if needed, infrastructure to coordinate Phase I/II clinical trials for evidence based rehabilitation interventions, which can be moved efficiently into Phase III trials or assist in Phase III or IV trials. This will be achieved by accomplishing the following 6 specific aims: Aim 1. Establish/maintain communications with the NIH P2C Program, this HITC, and medical rehabilitation teams across the US. We will work closely with Promo-C and the CCIT to support an interactive and intelligent website that provides education and resources to rehabilitation researchers. Aim 2. Provide content, statistical expertise and support for the development or refinement of study questions and/or provide the statistical monitoring plans, adaptive trial scenarios, interim assessments and p analyses. Aim 3. Offer standardized and successful mechanisms to ensure protocols are developed, operationalized rapidly, easily and reliably, with the appropriate partners in rehabilitation research. Aim 4. Advise on data management systems that are flexible enough to allow study-specific modules, but complete enough for consistency across studies. Aim 5. Advise on incorporation of mechanistic secondary outcomes as appropriate, and provide access to a comprehensive menu of HITC core facilities to complete these ancillary experiments at the HITC, or training to do so at the investigator's home institution or another P2C resource center. Aim 6. Support analysis of pooled data across the multiple studies facilitated by Collab-C, for both scientific contributions to the literature as well as future study planning.