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Authors
Huang, David T. http://orcid.org/0000-0001-7649-1633
McCreary, Erin K.
Bariola, J. Ryan
Wadas, Richard J.
Kip, Kevin E.
Marroquin, Oscar C.
Koscumb, Stephen
Collins, Kevin
Shovel, Judith A.
Schmidhofer, Mark
Wisniewski, Mary Kay
Sullivan, Colleen
Yealy, Donald M.
Axe, Meredith
Nace, David A.
Haidar, Ghady
Khadem, Tina
Linstrum, Kelsey
Snyder, Graham M.
Seymour, Christopher W.
Montgomery, Stephanie K.
McVerry, Bryan J.
Berry, Lindsay
Berry, Scott
Meyers, Russell
Weissman, Alexandra
Peck-Palmer, Octavia M.
Wells, Alan
Bart, Robert
Albin, Debbie L.
Minnier, Tami
Angus, Derek C.
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Article History
Received: 1 May 2021
Accepted: 6 May 2021
First Online: 25 May 2021
Declarations
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: University of Pittsburgh IRB STUDY21020179, approved March 1, 2021. UPMC Quality Improvement Review Committee Project ID 3280, approved April 20, 2021. We certify this trial has received ethical approval from the appropriate committees as described above.OPTIMISE-C19 is a quality improvement (QI) study, governed by approvals from both the UPMC QI committee and the University of Pittsburgh IRB. Currently, mAB therapy is approved for use under EUA issued by the FDA. There are no data on the relative benefits of one mAB versus any other. mABs are ordered by UPMC physicians as a generic referral order and the order is filled by UPMC pharmacy via therapeutic interchange. The selection of mABs available within pharmacy is overseen by the UPMC pharmacy and therapeutics committee. OPTIMISE-C19 provides the therapeutic interchange via random allocation. The UPMC Quality Improvement Committee approved the OPTIMISE-C19 study, including the random therapeutic interchange. The University of Pittsburgh IRB considered the randomized therapeutic interchange to be quality improvement and approved the additional data collection and analyses.Patients provide verbal consent to receive mAB therapy. UPMC requires physicians to provide and review with patients the EUA Fact Sheet for each mAB, and explain that the patient could receive any of the EUA-governed mABs. As per EUA requirements, physicians discuss the risks and benefits of mABs with patients, and patients consent to receive a mAB as part of routine care, should they desire mAB treatment. Patients are told which mAB they are receiving, and physicians and patients can agree to the assigned mAB or request a specific mAB. It is the treating physicians’ and patients’ choice to accept the assigned mAB or not. The QI committee considered these steps to represent adequate consent to participate. The IRB considered that the provision of mAB therapy therefore fell under quality improvement and only the additional data collection and analyses represented research. The IRB waived any additional consent requirements.
: Not applicable.
: The authors declare that they have no competing interests.
