HEAL ERN: Data Coordinating Resource Center

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Project Summary The NIH created the Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. As part of the HEAL initiative, the HEAL Effectiveness Research Network (ERN) was established to conduct comparative effectiveness trials for prevention and management of pain, while reducing risk of addiction. Five ERN trials have been implemented with data coordination support from the University of Utah Trial Innovation Center. This proposal is written in response to RFA-TR-22-012 to provide continued support for these five trials, as well as two additional trials that may be funded in response to RFA-AT-22- 005 (“HEAL Initiative: Sickle Cell Disease Pain Management Trials Utilizing the Pain Management Effectiveness Research Network Cooperative Agreement”). The University of Utah is responding to be the Data Coordination Resource Center (DCRC). We will continue to work collaboratively with each ERN study team and the other HEAL ERN Resource Centers to 1) develop, implementand monitor the ERN trials; 2) help respond to issues/protocol changes that emerge during trial implementation and initiate timely necessary changes to assure trial success; 3) provide collection and analysis of data; and 4) assist with timely publication of study results. Our application has three Specific Aims: 1. Work with ERN investigators and other HEAL ERN Resource Centers to provide collaborative clinical trial expertise and assistance in study and protocol design, single IRB, study implementation and management, accrual of subjects, interim study reporting, final study analyses, and assistance with timely publication and dissemination of study results. 2. Provide comprehensive data manage- ment for current and new ERN trials, including database and data collection systems, data management plans, data risk assessment and quality control, implementation of randomization, assistance with Data Safety Monitor- ing Board (DSMB) reports, and training for using the data collection systems. 3. Facilitate sharing of data from HEAL/ERN trials by incorporating HEAL Common Data Elements(CDEs) into protocols, continuing to support NIH program staff in development of HEAL CDEs, continued participation in the HEAL Collective Board, and preparation of final data sets suitable for deposit in NIH-designated repositories for incorporation into the HEAL Data Ecosystem. Our collaboration with ERN investigators and integration with the other Resource Centers will maximize the likelihood of successful and timely completion of the HEAL ERN clinical trials, leading to translation of research findings to the effective management of acute and chronic pain, while minimizing addictive opioid dosing regi- mens.