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Adverse effects of COVID-19 pandemic on a multicenter randomized controlled trial

Elie G Abu Jawdeh1, Carl E Hunt2, Eric Eichenwald3

  • 1University of Kentucky, Lexington, KY, USA. elie.abujawdeh@uky.edu.

Journal of Perinatology : Official Journal of the California Perinatal Association
|December 29, 2022
PubMed

Insights

The COVID-19 pandemic significantly reduced parent approach for infant consent in a clinical trial, with enrollment rates only partially recovering post-pandemic. Consent rates per approached parent remained stable.

Area of Science:

  • Clinical Trials
  • Epidemiology
  • Public Health

Background:

  • The COVID-19 pandemic presented unprecedented challenges to healthcare systems globally.
  • Clinical trial operations, particularly subject recruitment, were significantly impacted by public health measures and parental concerns.

Purpose of the Study:

  • To evaluate the impact of the COVID-19 pandemic on subject enrollment in a multicenter randomized controlled trial.
  • To assess changes in the ability to approach parents for consent and their subsequent consent rates.

Main Methods:

  • A multicenter randomized controlled trial design was employed.
  • Enrollment data, including the number of eligible infants approached and consented, were analyzed across five distinct epochs: baseline, peak pandemic, and recovery phases.

Main Results:

  • Parental approach rates decreased dramatically from 95.4% at baseline to 13.1% during the peak pandemic.
  • Enrollment recovery was incomplete, with post-pandemic approach rates at 84.9%.
  • Despite reduced approach rates, the consent rate among approached parents remained statistically unchanged.

Conclusions:

  • The COVID-19 pandemic severely hindered the ability to approach parents for infant consent in clinical trials.
  • Partial recovery in approach rates has been observed, but challenges in investigator-parent interactions persist.
  • Maintaining trial integrity requires adaptive strategies to overcome pandemic-related recruitment barriers.
Abstract

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