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Impact of the COVID-19 Pandemic on a Clinical Trial: A Quantitative Report on Study Engagement and Strategies

Shaaron E Brown1, Meagan Miller, Jodi Darring

  • 1Departments of Physical Therapy (Drs Brown and Shall and Ms Miller) and Neurology (Dr Harper), Virginia Commonwealth University, Richmond, Virginia; Rehabilitation and Movement Science Program (Dr Brown and Ms Inamdar), Department of Physical Therapy, Virginia Commonwealth University, Richmond, Virginia; University of Virginia Children's Hospital (Ms Darring and Dr Hyde), Charlottesville, Virginia; Division of Physical Therapy (Dr Inamdar), School of Medicine, West Virginia University, Morgantown, West Virginia; Division of Biokinesiology and Physical Therapy (Ms Salgaonkar and Dr Dusing), University of Southern California, Los Angeles, California; Division of Neonatology (Dr Burnsed), University of Virginia, Charlottesville, Virginia; Neuro-Developmental and Behavioral Pediatrics (Dr Stevenson), University of Virginia School of Medicine, Charlottesville, Virginia; Division of Neonatal Medicine (Dr Hendricks-Munoz), Department of Pediatrics, Children's Hospital of Richmond of VCU, Virginia Commonwealth University School of Medicine, and VCU Center on Health Disparities, Virginia Commonwealth University, Richmond, Virginia; Department of Biostatistics (Dr Thacker), School of Medicine, Virginia Commonwealth University, Richmond, Virginia.

Pediatric Physical Therapy : the Official Publication of the Section on Pediatrics of the American Physical Therapy Association
|July 25, 2023
PubMed

Insights

The COVID-19 pandemic negatively affected clinical trial rates for preterm infant physical therapy. Research teams adapted using telehealth to ensure study continuation and participant safety.

Area of Science:

  • Clinical research methodology
  • Pediatric physical therapy
  • Epidemiology

Background:

  • The COVID-19 pandemic presented unprecedented challenges to global clinical research operations.
  • Disruptions may have influenced study outcomes and data integrity.
  • Understanding pandemic effects is crucial for future research continuity.

Purpose of the Study:

  • To quantify the impact of the COVID-19 pandemic on key clinical trial metrics.
  • Specifically examining recruitment, retention, assessment, and intervention completion rates.
  • Assessing the pandemic's influence on a physical therapy trial for high-risk preterm infants.

Main Methods:

  • Longitudinal clinical trial data were analyzed.
  • Data spanned three periods: pre-pandemic, early pandemic, and peak pandemic (February 2019 - November 2021).
  • Key performance indicators including enrollment, retention, assessment completion, and intervention adherence were compared across these periods.

Main Results:

  • The peak pandemic period exhibited the lowest rates for recruitment, retention, assessment, and intervention completion.
  • These findings indicate a significant negative impact of the pandemic on study operations.
  • Despite challenges, the study successfully transitioned to telehealth.

Conclusions:

  • The COVID-19 pandemic adversely affected clinical trial participation and completion rates.
  • Adaptation to telehealth and hybrid models was essential for study continuation.
  • Research team flexibility, rapid response, and dedication were critical to overcoming pandemic-related obstacles and ensuring participant safety.
Abstract

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