Clinical Trials Leadership
The RECOVER clinical trials are led by the Clinical Trials Data Coordinating Center (CT-DCC) at the Duke Clinical Research Institute (DCRI) and the Administrative Coordinating Center (ACC) at RTI International (RTI).
The CT-DCC and ACC partnered with 5 protocol working groups, including Long COVID Patient, Caregiver, and Community Representatives, to design 8 clinical trials to explore 13 possible treatments for Long COVID. Experts in the selected study interventions and the Representatives will continue to support the clinical trials through implementation and sharing of study results.
Each clinical trial is led by principal investigators, or lead researchers, and supported by study teams. The About pages for each of the clinical trials include more information about each team.
Clinical Trials Data Coordinating Center (CT-DCC)
The CT-DCC at the Duke Clinical Research Institute (DCRI) is led by Kanecia Zimmerman, MD, PhD, MPH; Christina Barkauskas, MD; and Sean O’Brien, PhD. The DCRI, in collaboration with the National Institutes of Health (NIH) and RTI, supports 8 clinical trials studying 13 possible treatments, also called study interventions. Possible treatments being studied include drugs, non-drug treatment programs, medical devices, and other approaches.
The CT-DCC's specific areas of responsibility include:
- Scientific and Operational Leadership
- Platform Protocol Design and Implementation
- Site Management and Operations
- Data Management and Reporting
Administrative Coordinating Center (ACC)
The ACC at RTI International is led by Tracy Nolen, DrPH, and Craig Reist, PhD. RTI collaborates with the DCRI and the National Institutes of Health (NIH) to support the RECOVER Clinical Trials Program.
The ACC's specific areas of responsibility include:
- Contracts and Finance
- Program Operations
- Study Operations
- Technology and Data
Patient and Community Representatives
The RECOVER clinical trials leadership committees include Long COVID Patient, Caregiver, and Community Representatives from many different backgrounds. The Representatives play an important role throughout the lifecycle of each clinical trial by:
- Participating in Protocol Working Groups to develop the clinical trial protocols, or study plans
- Sharing their personal experiences to help make sure the clinical trials include and benefit communities that are most affected by Long COVID
- Providing their input on study materials to make sure they meet the needs of participants
- Supporting community engagement efforts to raise awareness about Long COVID and RECOVER clinical trials
- Helping to share overall study results when the clinical trials are finished and the data have been analyzed
The RECOVER Initiative’s National Community Engagement Group (NCEG) also works to ensure that RECOVER research meets the needs of patients, caregivers, and community members. NCEG works closely with the leaders of RECOVER observational cohort studies and clinical trials, as well as other RECOVER groups, to guide them on the best ways to connect with participants and the Long COVID community.
Clinical Trials (CT) Steering Committee
The RECOVER CT Steering Committee is a group of experts that makes sure the clinical trials align with the overall goals of the RECOVER Initiative by
- Helping to develop and optimize the clinical trial portfolio
- Formally reviewing and providing feedback on clinical trial protocols, or study plans
- Providing high-level guidance to ensure the clinical trials meet their scientific goals
- Assessing scientific research progress
- Considering strategies to ensure timely implementation and addressing operational challenges
- Serving as a source of clinical, scientific, and patient input
The CT Steering Committee reports to the Executive Committee as needed on:
- The status of the clinical trials
- New challenges and opportunities that arise
- Requested changes to daily operations or procedures for RECOVER clinical trials
- Any other issues that might impact the goals of the clinical trials
CT Steering Committee Voting Members
- Laurie Gutmann - Co-chair
- Eldrin F. Lewis - Co-chair
- Kevin Anstrom
- Lucinda Bateman
- Marta Cerda
- Christopher Coffey
- Judith Currier
- Anne Davidson
- Brian Fallon
- David Knopman
- Barry Make
- Christine Maughan
- Susan Redline
- Cyndya A. Shibao
- Richard Whitley
- Gloria Yeh
CT Steering Committee Ex-Officio Members
- Marie-Abele Bind
- Jason Gerson
- Tracy Nolen
- Leonard Sacks
- Andrea Troxel
- Kanecia Zimmerman
Data and Safety Monitoring Board (DSMB)
The DSMB reviews each clinical trial protocol, or study plan, before the study begins. Once the clinical trials begin, the DSMB monitors the data, or information, collected in RECOVER research and the progress of the clinical trials. The DSMB identifies safety issues that may come up during the clinical trials and also makes recommendations to correct any data quality issues.