22 Sep ITHS Hub Liaison Team Brings COVID-19 Trials to Patients across WWAMI
The ITHS Hub Liaison Team, led by Drs. Chris Goss and Ann Melvin, is a multidisciplinary team of research operations, informatics, regulatory, contracts, recruitment, and ethics experts from the University of Washington and Seattle Children’s Hospital. The team is dedicated to supporting the Trial Innovation Network projects at ITHS. The HUB Liaison Team has been hard at work as the Trial Innovation Network pivots to support COVID-19 treatment trials.
The Ask
Earlier this summer, the Hub Liaison Team was asked to identify sites to enroll two trials supported and prioritized by NCATS – the PassItOn trial and the ACTIV-1 trial. Funded by NCATS, PassItOn is a blinded, placebo-controlled trial of convalescent plasma. The ACTIV-1 platform trial is funded by Operation Warp Speed and studies the benefit of different immunomodulators on a background of remdesivir. Both trials are COVID-19 treatment trials for hospitalized patients.
To provide more context around the importance of this ask, in a September 22, 2020 NIH news release, NIH Director Francis Collins said, “The evidence on convalescent plasma as a treatment for severe cases of COVID-19 is promising, but incomplete. We need to carry out rigorous randomized control clinical trials to determine how this therapy can improve outcomes. While the world waits for an effective vaccine, it is vital that we simultaneously expand the options for available treatments for those currently suffering from the worst effects of this disease.”
We need to carry out rigorous randomized control clinical trials to determine how this therapy can improve outcomes suffering from the worst effects of this disease.”
The UW Hub Liaison Team has spent the last three years building an infrastructure and fostering connections within the UW and across WWAMI to identify partner researchers and facilitate participation in Trial Innovation and the NIH Helping to End Addiction Long-Term, Pain Management Effectiveness Research Networks. Earlier this summer, when NCATS asked for the expedited identification of partner sites for both the PassItOn and ACTIV-1 studies, the Hub Liaison Team was more than ready to support this request. They worked with UW study teams, the Northwest Participant & Clinical Interactions (NW PCI) Network, and the Universities of Chicago & Michigan CTSAs to identify a total of 7 sites in Washington, Montana, Idaho, Michigan, and Illinois interested in enrolling patients into these studies.
While the world waits for an effective vaccine, it is vital that we simultaneously expand the options for available treatments for those currently suffering from the worst effects of this disease
ITHS NW PCI Network Model
The Hub Liaison Team at UW has also worked closely with the ITHS NW PCI Network, a group of 17 clinical and translational research centers affiliated with medical centers, health systems and universities in the region, to develop a model that brings clinically relevant, federally funded research to patients who live outside of greater Seattle. “We built a responsive and flexible model with the NW PCI Network leadership. The value of this partnership was immediately apparent when NCATS asked us to prioritize the ACTIV-1 and PassItOn studies. It’s exciting and a privilege to be a part of this work,” said Charlie Gregor, ITHS Hub Liaison Team’s point of contact with the NW PCI & Trial Innovation Networks.
“A very small percentage of patients receive care at academic medical centers where research is the norm, yet all of our tax dollars support these and other NIH funded studies. For a disease like COVID-19 in which there are no proven interventions, research is the best opportunity for patients to gain access to promising therapies, and it is critical that access is equitable across all patients in our region” shared Laurie Hassell, ITHS Director of Community Engagement and Coordinator of the NW PCI Network.
Next Steps
Identifying partner sites is only one step to bringing this research to patients. Both studies are using reimbursement models centered around delivering incentives when milestones are met. These studies have ambitious (21-30 day) goals for receiving IRB approval and contract approvals. The Hub Liaison Team will continue to provide ongoing implementation support to help activate these study teams quickly and on time. “We hope to identify opportunities to accelerate future clinical trial start up with lessons learned from this pandemic,” concluded Mr. Gregor.
ITHS is proud of the ITHS Hub Liaison Team & the NW PCI Network for this extraordinary work. For more information please contact Charlie Gregor at cgregor2@uw.edu.
To learn more about the Hub Liaison Team and NW PCI Network model, please join a Trial Innovation Network webinar Feasibility of Connecting Regional Research Programs to National Multisite Trials Emanating from the CTSA Trial Innovation Network presented by Charlie Gregor and Laurie Hassel on October 21st at 9:00am PDT. To register, please click here.
