Clinical trial coordination of multifaceted ethical and regulatory oversight entities during the COVID-19 public health emergency

Amy Gawad¹, Jessica Mendoza², Megan Singleton³, Ryan Majkowski⁴, Erica Hopkins⁵, Jordyn Carll⁶, Cindy MacInnis⁷, Daniel Amirault⁸, Bahiyyah Jackson⁹, Nichol McBee¹⁰, Andrew Mould¹¹, Lindsay M Eyzaguirre¹², Cecilia Pessoa-Gingerich¹³, Shmuel Shoham¹⁴, David Sullivan¹⁵, Karen Lane¹⁶

Affiliations

¹ Department of Neurology, Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: agawad1@jhu.edu.
² U.S. Army Medical Research and Development Command, Office of Human and Animal Research Oversight, Office of Human Research Oversight, Fort Detrick, MD, USA. Electronic address: jessica.l.mendoza19.civ@health.mil.
³ Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: msingl16@jhmi.edu.
⁴ Department of Neurology, Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: rmajkow1@jhmi.edu.
⁵ Department of Neurology, Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: erica.hopkins@northwestern.edu.
⁶ Department of Neurology, Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: jcarll3@jhmi.edu.
⁷ Department of Neurology, Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: cindy.macinnis@asco.org.
⁸ Department of Neurology, Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
⁹ Department of Neurology, Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: bjacks28@jhmi.edu.
¹⁰ Department of Neurology, Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: nmcbee@jhmi.edu.
¹¹ Department of Neurology, Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: amould@jhmi.edu.
¹² Department of Neurology, Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: Leyzaguirre@jhu.edu.
¹³ Department of Neurology, Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: cecilia@jhmi.edu.
¹⁴ Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: sshoham1@jhmi.edu.
¹⁵ Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD, USA; W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: dsulliv7@jhmi.edu.
¹⁶ Department of Neurology, Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: klane@jhmi.edu.

PMID: 41453518
DOI: 10.1016/j.cct.2025.108207

Free article

Clinical trial coordination of multifaceted ethical and regulatory oversight entities during the COVID-19 public health emergency

Amy Gawad et al. Contemp Clin Trials. 2026 Feb.

Free article

. 2026 Feb:161:108207.

doi: 10.1016/j.cct.2025.108207. Epub 2025 Dec 24.

Authors

Affiliations

¹ Department of Neurology, Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: agawad1@jhu.edu.
² U.S. Army Medical Research and Development Command, Office of Human and Animal Research Oversight, Office of Human Research Oversight, Fort Detrick, MD, USA. Electronic address: jessica.l.mendoza19.civ@health.mil.
³ Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: msingl16@jhmi.edu.
⁴ Department of Neurology, Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: rmajkow1@jhmi.edu.
⁵ Department of Neurology, Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: erica.hopkins@northwestern.edu.
⁶ Department of Neurology, Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: jcarll3@jhmi.edu.
⁷ Department of Neurology, Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: cindy.macinnis@asco.org.
⁸ Department of Neurology, Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
⁹ Department of Neurology, Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: bjacks28@jhmi.edu.
¹⁰ Department of Neurology, Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: nmcbee@jhmi.edu.
¹¹ Department of Neurology, Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: amould@jhmi.edu.
¹² Department of Neurology, Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: Leyzaguirre@jhu.edu.
¹³ Department of Neurology, Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: cecilia@jhmi.edu.
¹⁴ Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: sshoham1@jhmi.edu.
¹⁵ Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD, USA; W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: dsulliv7@jhmi.edu.
¹⁶ Department of Neurology, Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: klane@jhmi.edu.

PMID: 41453518
DOI: 10.1016/j.cct.2025.108207

Abstract

We implemented two outpatient randomized controlled trials of COVID-19 convalescent plasma during the COVID-19 public health crisis. Unique challenges included how to maneuver all the moving parts to precipitously mobilize and guide clinical teams and facilities through multiple review groups, to reach multiple target populations, and to share trial results. We describe how a flexible clinical trial coordinating center team approached and robustly coordinated multiple regulatory agencies and protocol changes to keep up with rapidly changing pandemic conditions and knowledge. Four agencies oversaw ethical and regulatory reviews for 26 participating sites, two protocols, and two master informed consent forms, in English and Spanish, through a two-month start-up cycle and 68 protocol and consent form changes, culminating in a national conversation of positive trial results presented in a public forum by the site investigators to trial participants. Ethical and regulatory reviews were at a faster than usual pace, sites were ready to activate in 12-15 days, and about 2 % of those transfused used Spanish language materials. Although these extraordinary practices cannot become standard, they can provide lessons for normal and emergency trial conduct. From a clinical trial coordinating center viewpoint, we recommend developing emergency interagency standard operating procedures (SOPs) for coordinating protocol reviews and emergency ceding guidelines among agencies when multiple regulatory reviews are required. English and non-English Informed Consent Forms (ICFs) developed centrally and in parallel and including a return of trial results to participants as a contact option should help trials improve participant-centered outreach.

Keywords: COVID-19 clinical trials; Clinical trial management; Convalescent covid plasma; Human research protection program (HRPP) reviews; Informed consent form; Return of trial results; Single institutional review board (sIRB) oversight.

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Conflict of interest statement

Declaration of competing interest The opinions and assertions herein are the private views of the authors and are not to be construed as official or as reflecting the views of the U.S. Army Medical Research and Development Command, the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, the U.S. Army, or the U.S. Department of War. S.S reports on involvement with Pfizer (data review committee), Cidara (data review committee), F2G (research grant), Zateo (research grant), Ansun (research grant). All other authors report no relevant disclosures.

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Clinical trial coordination of multifaceted ethical and regulatory oversight entities during the COVID-19 public health emergency

Affiliations

Clinical trial coordination of multifaceted ethical and regulatory oversight entities during the COVID-19 public health emergency

Authors

Affiliations

Abstract

Conflict of interest statement

MeSH terms

LinkOut - more resources

Full Text Sources