Expert Insights

Expert Insights

Clinical Trials During COVID-19

Clinical Trials During COVID-19
08 April 2020

COVID-19 will inevitably have a significant impact on the conduct and management of clinical trials and trial participants worldwide. In many countries, extraordinary measures have been implemented to slow down the spread of COVID-19. These include patients and monitors not being permitted to visit study sites, trial participants and/or site staff and investigators practicing self-isolation, as well as health care professionals shifting their focus toward critical tasks to fight COVID-19.

Therefore, regulators around the globe, including the FDA and EMA, have issued guidance on how to manage clinical trials during the COVID-19 pandemic, including studies for the development of treatments and vaccines against COVID-19 infections.

Due to the rapidly evolving situation, guidance documents are being updated frequently. Synteract is constantly monitoring the global situation to ensure all clinical trials managed by Synteract are compliant with international guidance.

All guidances published by regulators have one thing in common: The highest goals of any measures implemented due to COVID-19 must be to ensure the rights, safety, and well-being of clinical trial participants, maintain compliance with Good Clinical Practice (GCP), and minimize risks to trial and data integrity. The safety of trial participants must always have highest priority.

Measures put in place to fight COVID-19 may impact the completion of trial assessments, the completion of trial visits, and the provision of Investigational Medicinal Products (IMPs). The feasibility of starting a new clinical trial or including new trial participants in an ongoing trial should also be critically assessed by sponsors.

Measures should generally be agreed upon with investigators and can be implemented by the sponsor or the investigator.

What is permitted may differ by country due to national legislation and guidance and may depend on the measures enforced for a specific study. These measures may be submitted as an urgent safety measure (USM) first, with a substantial amendment (SA) application submitted later, with Ethics Committees (ECs) and Institutional Review Boards (IRBs) notified and the adjustments properly documented in both the Trial Master File (TMF) and Clinical Study Report (CSR). If changes to the protocol and/or Informed Consent are triggered, a substantial amendment is needed, but may be implemented without waiting for approval, depending on national requirements.

For published guidance, it is common practice that the measures implemented for a specific clinical trial be based on a risk assessment performed by the sponsor. This risk assessment must determine the trial-specific situation considerations for each site, and the measures defined must prioritize subject safety and data integrity. Synteract has created a detailed risk assessment process for gauging the impact of the COVID-19 pandemic on each study to support our sponsors. As the situation develops, a reassessment must be performed if the measures implemented are still indicated or appropriate.

Clinical trials for the treatment of COVID-19

Most regulators around the globe are committed to prioritizing clinical trials dealing with the treatment of COVID-19 or the development of COVID-19 vaccines, and are working to accelerate the development of those compounds. These studies are supported in an effort to grant access to treatment for as many patients as possible. Authorities, including Ethics Committees and IRBs may accept much shorter turnaround times for the approval of such studies and many of them have established specific portals and/or email addresses where COVID-19-related applications and questions should be sent, e.g., COVID19-productdevelopment@fda.hhs.gov or 2019-ncov@ema.europa.eu.

In summary, specific procedures for seeking scientific advice have been put in place by the FDA, EMA, and other national authorities to facilitate the development of products for the treatment of COVID-19. Synteract is constantly monitoring the regulatory environment in order to offer the best support to our clients for development of their compounds.

Our Executive Director of Regulatory Affairs, Ludwig Baumann, developed this blog to offer some regulatory insights for drug developers during the COVID-19 pandemic. Stay tuned for more updates.

Please Contact us today to learn how Synteract can bring your next infectious disease or vaccine clinical trial to life.

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