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How Do I Report Dermatology Protocol Deviations Caused by COVID-19?

How Do I Report Dermatology Protocol Deviations Caused by COVID-19?
16 April 2021

Among the many disruptions caused by COVID-19, measures to control the virus have made it more challenging to collect data for endpoint assessments. To guide sponsors and CROs through protocol changes that affect the statistical analysis plan (SAP), the FDA released updated guidance on statistical analysis of the primary and key secondary endpoints.

The guidance is especially helpful for dermatology trials, which rely heavily on clinical outcome assessments for primary endpoint data — the collection of which has changed dramatically due to COVID-19.

Protocol deviation reporting makes it difficult for study statisticians and programmers to pull out COVID-19-related deviations and include them in a summary table; nevertheless, it’s important to continue reporting those protocol deviations.

The FDA wants to know COVID-19’s impact at both the study and subject level. To comply, note the following in your case report forms (CRFs):

  • Missed visits/delayed visits (out of window)
  • Impact on dosing (site level, trial participant level, supplier level)
  • Discontinuations due to COVID-19 (subject level and site level)
  • Use of alternative or rescue treatments (due to COVID-19)
  • Adverse events related to COVID-19
  • Missed endpoint evaluations/use of alternative methods of endpoint evaluations
  • Additional factors that contribute to the impact on data reporting should be noted as well, such as telemedicine in place of clinic visits or efficacy assessments from photographs taken by subjects

As you review data, give your risk assessment a thorough statistical review. Assess the amount of missing data: How much is missing? Why is it missing? Address any site-level issues immediately.

As you review the risk assessment, update the SAP to add additional analysis to support your study. If you decide to add a modified per-protocol population, consider this decision from a clinical perspective before making the change. A potential loss of efficacy may influence your decision.

For a closer look at the latest biostatistical and regulatory considerations related to dermatology clinical trials, download our guide: Biostatistical and Regulatory Considerations for Dermatology Trials.

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