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Infectious Diseases

Estimated Clinical Trial Capacity of Sites Participating in the COVID-19 Convalescent Plasma Expanded Access Program

Educational Objective
To identify the key insights or developments described in this article

1 Credit CME

JAMA Network Open

Published Online: October 19, 2022

Research Letter

Article Information and Disclosures

M. Sage Gustafson, MA¹;

Chuan Hong, PhD³;

Miles Meline, BA⁴;

Daniella Peña, BS⁵;

Charis Tang, BA⁶;

Holly Fernandez Lynch, JD, MBE⁷

Author Affiliations

¹Division of Medical Ethics, NYU Langone Health, New York, New York
²University of Southern California, Los Angeles, California
³Department of Population Health, NYU Langone Health, New York, New York
⁴University of Pennsylvania, Philadelphia, Pennsylvania
⁵Cornell University, Ithaca, New York
⁶Rice University, Cupertino, California
⁷Department of Medical Ethics and Health Policy Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania

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Expanded access (EA) allows patients to receive unapproved medicines outside trials only if doing so would not interfere with drug development. However, interference may not be obvious: is EA needed because a site lacks trial capacity, or is EA inhibiting trial initiation? These questions were highlighted in the context of the largest-ever EA program (EAP), implemented for COVID-19 convalescent plasma (CCP). The program was initially planned for 5000 patients but ultimately enrolled 105 717 patients.¹ We sought to estimate the trial capacity of participating CCP EAP sites, hypothesizing that many sites could have supported CCP research to better guide clinical care.

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Article Information

Accepted for Publication: September 1, 2022.

Published: October 19, 2022. doi:10.1001/jamanetworkopen.2022.37540

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2022 Gustafson MS et al. JAMA Network Open.

Corresponding Author: Holly Fernandez Lynch, JD, MBE, University of Pennsylvania Perelman School of Medicine, 423 Guardian Dr, 1426 Blockley Hall, Philadelphia, PA 19104 (lynchhf@pennmedicine.upenn.edu).

Author Contributions: Ms Gustafson had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Gustafson, Fernandez Lynch.

Acquisition, analysis, or interpretation of data: Gustafson, Patel, Hong, Meline, Pena, Tang.

Drafting of the manuscript: Gustafson, Patel.

Critical revision of the manuscript for important intellectual content: Gustafson, Hong, Meline, Pena, Tang, Fernandez Lynch.

Statistical analysis: Patel, Hong, Meline.

Administrative, technical, or material support: Gustafson, Patel, Pena, Tang, Fernandez Lynch.

Supervision: Gustafson, Fernandez Lynch.

Conflict of Interest Disclosures: Ms Gustafson reported serving as an affiliate of the NYU Grossman School of Medicine Compassionate Use and Preapproval Access Working Group (CUPA) during the conduct of the study. Mr Meline and Ms Pena reported receiving funding through the Leonard Davis Institute at the University of Pennsylvania. Dr Fernandez Lynch reported receiving grants from The Greenwall Foundation and the NIH during the conduct of the study; personal fees from The Robert Wood Johnson Foundation outside the submitted work; and serving as a member of the NYU Grossman School of Medicine CUPA. No other disclosures were reported.

Additional Contributions: We thank John Holmes, PhD, Institute for Biomedical Informatics, Perelman School of Medicine, University of Pennsylvania, for guidance regarding study methodology and reporting, and Kyle Cunningham-Rhoads, BA, Stats Perform, for input regarding data analysis. No compensation was provided for this assistance.

References

Joyner MJ . Sites with enrolled physicians. Convalescent Plasma COVID-19 (Coronavirus) Treatment. Accessed September 10, 2022. https://www.uscovidplasma.org/-/media/kcms/gbs/patient-consumer/documents/2020/12/17/20/37/library-of-congress-participation.pdf

OSF Project Files. Gustafson MS, Lynch HF, Tang C, Patel A, Pena D, Meline M. Characteristics of trials at sites participating in the COVID-19 Convalescent Plasma Expanded Access Program. April 11, 2022. Accessed September 10, 2022. https://osf.io/n4xgd/

Senefeld JW , Johnson PW , Kunze KL , et al. Access to and safety of COVID-19 convalescent plasma in the United States Expanded Access Program: a national registry study. PLoS Med. 2021;18(12):e1003872. doi:10.1371/journal.pmed.1003872 PubMed Google Scholar Crossref

Infectious Diseases Society of America. IDSA guidelines on the treatment and management of patients with COVID-19. August 30, 2022. Accessed August 31, 2022. https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/

National Institutes of Health COVID-19 Treatment Guidelines Panel. COVID-19 convalescent plasma. April 29, 2022. Accessed August 31, 2022. https://www.covid19treatmentguidelines.nih.gov/therapies/anti-sars-cov-2-antibody-products/convalescent-plasma/

Joyner MJ , Casadevall A . For early testing of convalescent plasma, we were “building the plane while we were flying it.” STAT. March 4, 2021. Accessed June 17, 2022. https://www.statnews.com/2021/03/04/for-early-testing-of-convalescent-plasma-we-were-building-the-plane-while-we-were-flying-it/

AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
1.00 CME points in the American Board of Surgery’s (ABS) Continuing Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.