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The CREST-2 experience with the evolving challenges of COVID-19: A clinical trial in a pandemic

James F Meschia1, Kevin M Barrett2, Robert D Brown2

  • 1From the Department of Neurology (J.F.M., K.M.B., T.G.B.), Mayo Clinic, Jacksonville, FL; Department of Neurology (R.D.B.), Mayo Clinic, Rochester, MN; Department of Neurology (T.N.T., J.H.V.), Medical University of South Carolina, Charleston; Department of Epidemiology (V.J.H.) and Department of Biostatistics (G.H.), University of Alabama at Birmingham; Department of Surgery (B.K.L.), University of Maryland, College Park. meschia.james@mayo.edu.

Neurology
|May 3, 2020
PubMed

Insights

The coronavirus disease 2019 pandemic impacted a major stroke prevention trial, necessitating changes in patient enrollment and follow-up. Strategies were implemented to protect patients and ensure trial objectives were met despite disruptions.

Area of Science:

  • Neurology
  • Clinical Trials
  • Epidemiology

Background:

  • The coronavirus disease 2019 (COVID-19) pandemic caused widespread disruption to global health systems and research.
  • Clinical trials faced unprecedented challenges, including operational adjustments and patient safety concerns.

Purpose of the Study:

  • To describe the impact of the COVID-19 pandemic on the National Institute of Neurological Disorders and Stroke (NINDS) Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial.
  • To outline the mitigation strategies implemented to ensure patient safety and trial continuity.

Main Methods:

  • The study details the immediate effects of the pandemic on trial operations, including suspension of new patient enrollment.
  • Methods involved transitioning patient follow-up from in-person visits to telephone contacts.
  • Ethical considerations for patient protection were paramount in adapting trial procedures.

Main Results:

  • The trial experienced significant operational changes due to the pandemic, including a halt in new participant recruitment.
  • Patient follow-up was successfully adapted to a remote, telephone-based model.
  • Mitigation strategies were developed to address pandemic-related challenges.

Conclusions:

  • The pandemic necessitated rapid adaptation of clinical trial protocols to ensure patient safety and data integrity.
  • The experience highlights the need for flexible and resilient trial designs in public health emergencies.
  • Successful mitigation allowed the trial to continue pursuing its stroke prevention objectives.

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