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Conducting dermatology clinical trials during the COVID-19 pandemic

Tabrez Sheriff1, Helen Dickenson-Panas2, Dédée F Murrell1

  • 1Department of Dermatology, St George Hospital, Sydney, New South Wales, Australia; University of New South Wales, Sydney, New South Wales, Australia.

Clinics in Dermatology
|May 11, 2021
PubMed

Insights

The COVID-19 pandemic created significant challenges for clinical trials, impacting operations and patient safety. This study offers practical recommendations for managing dermatology clinical trials during this evolving health crisis.

Area of Science:

  • Clinical Research Operations
  • Infectious Disease Epidemiology
  • Dermatology

Background:

  • The COVID-19 pandemic introduced unprecedented challenges to clinical trial conduct.
  • Disruptions included site closures, travel restrictions, and participant/staff infections with SARS-CoV-2.
  • These factors complicated adherence to visit schedules, laboratory testing, and protocol procedures.

Purpose of the Study:

  • To provide practical considerations and recommendations for dermatology clinical trial operations during the COVID-19 pandemic.
  • To address challenges in maintaining patient safety and trial continuity amidst pandemic-related disruptions.
  • To guide amendments of clinical trial protocols and ethics board approvals.

Main Methods:

  • Review of operational challenges faced by clinical trial sites, CROs, and sponsors during the COVID-19 pandemic.
  • Analysis of the impact of pandemic-related issues on trial procedures and investigational product delivery.
  • Development of practical recommendations for adapting dermatology clinical trials.

Main Results:

  • Swift actions were necessary from stakeholders to ensure patient safety and trial continuity.
  • Protocol amendments and ethics board approvals are crucial for adapting to new operational realities.
  • Specific strategies are needed to mitigate the impact of disruptions on trial integrity.

Conclusions:

  • Adapting clinical trial operations is essential for maintaining research continuity during public health emergencies.
  • Proactive planning and flexible approaches are key to overcoming pandemic-related challenges in dermatology research.
  • Recommendations focus on ensuring patient safety, data integrity, and regulatory compliance in a changing landscape.

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