High-Impact Trials Center: Pilot Studies Component

University Of Alabama At Birmingham, Birmingham AL

Investigators

Linked publications & trials

Abstract

PROJECT SUMMARY The central goal of the Pilot Studies Component (Pilot-C) of the P2C National Resource Center for High-Impact Clinical Trials in Medical Rehabilitation (High-Impact Trials Center, HITC) is to catalyze the success of medical rehabilitation researchers and interdisciplinary teams by providing consultation, seed funds, key expertise and resources, and ultimately feedback, to medical rehabilitation researchers for the conduct of innovative pilot projects, early-stage proof-of-concept studies, and futility studies needed to shape more definitive clinical trials. The central goal will be met by achieving the following aims: Aim 1. To work closely with the Collaborative Opportunities Component (Collab-C), providing consultation to medical rehabilitation research teams on how to: 1) Formulate and refine strong and impactful research questions; 2) Identify the goals and aims needed to achieve future clinical outcome trials. Aim 2. To identify and prioritize the most competitive proposals for both pilot studies and voucher funding via an annual peer review process. Aim 3. To provide expertise, resources, and/or mentorship to selected pilot study awardees with ongoing availability during the planning and implementation phases in order to: 1) Bolster the scientific yield of each pilot study; and 2) Position each awardee for a subsequent, highly competitive clinical trial application. Aim 4. To provide constructive and substantive feedback to applicants not selected for funding, and to direct those applicants toward other programs and opportunities within the Center that can strengthen future applications. The Pilot-C will award four $40K pilot studies per year. Three awards will be funded by the P2C national resource center grant and will be awarded to the national community of medical rehabilitation researchers. The fourth award will be sponsored by the UAB School of Medicine, allowing for UAB investigative teams to compete in the pilot program but limited to this one award funded by UAB. To be considered for funding, a UAB application must achieve a rank among the top four of all pilot study applications. Awarded investigative teams will receive 1-2 years of funding along with key resources and mentorship necessary to develop exceptional, future investigator-initiated clinical trials. A Pilot-C Vouchers Program ($30K annually) will facilitate HITC resource utilization by investigative teams from the national community not awarded pilot study funding. Vouchers (~$5- 15K) will enable investigators to take advantage of needed Center resources such as biostatistics and clinical trials design expertise, core laboratories, etc. for the purposes of generating preliminary data and receiving protocol advice. Overall, the Pilot-C Vouchers Program will enhance interactions between the investigator base and the Center.