EMA Updates Guidance on Clinical Trials Amid COVID-19 Restrictions

5/05/2020

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As we are settling into the new normal of COVID-19 restrictions, many are still unsure how to proceed to maintain subject safety and data integrity and face decisions on whether to continue clinical trials, suspend them, or even start a new trial. Questions remain about how to securely monitor source data remotely while maintaining data privacy and following regulations, and new issues became evident, such as how subjects could receive investigational product at home. There are many sources of information to guide sites and sponsors/CROs through these challenges.

In the last week, the European Medicines Agency (EMA) recently updated their Guidance on the Management of Clinical Trials During the COVID-19 Pandemic to include:

  • information about shipping investigational product (IP) to subjects,

  • additional information about monitoring, and

  • remote source data verification.

If IP needs to be shipped to subjects in their homes to ensure safety from COVID-19 exposure and to avoid treatment interruptions, there are a few important factors that need to be taken into consideration, including:

  • If the IP is appropriate to be administered in a home setting (e.g., safely)

  • If the IP can be stored appropriately

  • Shipping conditions (e.g., temperature requirements)

  • How accountability is documented

  • How compliance is ensured and measured

Risk-based monitoring should be implemented where the focus is on critical data points or processes and riskier sites. Remote source data verification (SDV) is only necessary for quality control of essential safety or efficacy data or for trials involving COVID-19 trials. The sponsor should weigh the additional burden on sites versus the necessity of the SDV during the crisis. Where SDV is needed, it can be accomplished by 1) allowing access to the subjects’ electronic medical records or 2) sharing pseudonymized (deidentified) copies of source data electronically.

The EMA guidance clarifies that decisions should be based on a risk-benefit assessment and considerations of regional restrictions, with the subjects’ health and safety the priority.

Additional sources of information include our related recorded webinars:

  1. ‘Remote Monitoring Operations and Maintaining HIPAA, GCP, and COVID-19 Restrictions’ including a helpful Q&A reference free with purchase.

    • The focus is on the sponsor/CRO’s perspective. Purchase here.

  2. ‘A Case for Sponsor Monitoring Remote Access to a Site’s EMR!’

    • The focus is on the site’s perspective. Purchase here.

Recorded webinars will be available for 10 days after purchase.

- The Clinical Pathways Team

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