COVID-19 Clinical Trial Process and Committees

The COVID-19 clinical trials team has three distinct groups:

• the Clinical Trials Steering Committee,
• the Scientific Review committees (1 and 2), and
• the Clinical Trials Implementation Committee.

Listing of open and upcoming COVID clinical trials

COVID-19 CLINICAL TRAILS PROCESS

The Clinical Trials Steering Committee (CTSC) is co-chaired by Ben Medoff, Boris Juelg, Ryan Sullivan, Jason Griffiths, Crystal North, Chana Sacks, Michael Dougan. This group of investigators bring expertise in clinical trials across the care environments and therapeutic modalities. They engage with investigators in the development of investigator-initiated trials and consideration of industry-sponsored trials. In addition to deliberating on the merits of the concept/protocol, considerations of competing protocols and feasibility of execution are discussed.

Protocols that are endorsed for adoption at MGH by the CTSC go to the MGH COVID-19 Scientific Review Committees (1 and 2) which formally approves/disapproves protocols. Those that are SRC approved and later IRB approved (outside of the MGH COVID-19 clinical research review process) then enlist the support of the Implementation Committee (not a review body) to empower them for activation and ongoing execution thereafter. For SRC review we have a 24 hour review cycle, during which time we achieve a rolling quorum and make a decision.

CLINICAL TRIALS COMMITTEES

• Clinical Trials Steering Committee (CTSC)

Co-chaired by Ben Medoff, Boris Juelg, Ryan Sullivan, Jason Griffiths, Crystal North, Chana Sacks, Michael   Dougan

This group of investigators bring expertise in clinical trials across the care environments and therapeutic modalities. They will engage with investigators in the development of investigator-initiated trials and consideration of industry-sponsored trials. In addition to deliberating on the merits of the concept/protocol, considerations of competing protocols and feasibility of execution will be discussed. This group will also directly interact with pharmaceuticals companies offering access to investigational agents, but for which an MGH investigator has not yet been approached.

• Scientific Research Committees

The Scientific Review Committee 1 (SRC1) for Medical Intervention protocols

Committee members: Andrew Luster, Elizabeth Hohmann, Robert Parker, Dianne Finkelstein, Paul Alfille, Chana Sacks, Thorsten Mempel, Dean Hess, Raymond Chung, Matthias Nahrendorf, Douglas Kwon, Gregory Cote, Brian Healy, Krishan Reddy, Mason Freeman, Andrea Foulkes

The Scientific Review Committee 2 (SRC2) for Non-Medical Intervention protocols

Committee members: Roy Perlis, Mason Freeman, Robert Parker, Brian Healy, Dianne Finkelstein, Andrea Foulkes, Sara Silacci, Areej El-Jawahri, Krishna Reddy

In light of a strained clinical care environment and in intent to investigate multiple therapeutic approaches in parallel, this committee’s work is needed to provide a scientifically informed assessment of those interventions anticipated to be most impactful.

• Clinical Trials Implementation Committee

Committee members: Kathryn Hall, Dejan Jurik, Chana Sacks, Crystal North, Krishna Reddy, Michael Filbin, Dean Hess, Elizabeth Hohman, Jonathan Jackson, Sydney Montesi, Moly Paras, Krishna Reddy

This group has recruited clinical care and research experts from across the MGH community to enable conduct of COVID-19 clinical trials that have been prioritized by the COVID-19 Clinical Trial Scientific Review Committee prior to and following IRB approval.

The Committee works with investigators and study personnel to ensure that operational issues have been addressed in protocol design, to address obstacles to implementation during study conduct, and monitor patient and staff safety.