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The latest FDA and EMA guidelines permit sites, sponsors, and CROs to adjust their operations to meet changing conditions for ongoing trials, including some concerning the safety of participants, that must be met in order for new solutions to be considered.
Within the past week, both the FDA1 and European Medicines Agency (EMA)2 issued guidance with regards to the conduct of clinical trials during the COVID-19 pandemic.
This swift action taken by the regulatory agencies was in direct response to global concerns around assuring the safety of clinical trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during this unprecedented time.
These latest regulatory guidelines permit sites, sponsors, and CROs to adjust their study operations to meet changing conditions for ongoing trials, however there are conditions that must be met in order for new solutions to be considered.
Both sets of guidance outline important information the clinical trial industry needs to know now about continuing existing clinical trial operations and considerations for new study start-up during the COVID-19 pandemic.
Regulatory agencies no doubt are monitoring the ongoing epidemic and thankfully, are responding to the outbreak with additional guidance. In fact, the FDA just released an appendix to their guidance, with additional information. Key items of note include:
These are unsettling times, and a priority for organizations that support clinical trials needs to be to ensure the clinical research community feels educated and supported, by providing reliable information and links in our new COVID-19 Resource Center.
Despite the global crisis, technology solutions can help keep studies solvent and access to medicines intact.
Use this time to listen to clients, including CROs, sites, or sponsors, immediate needs-whether that be in client conversations or surveys. This feedback can be used to incubate ideas and innovate on new solutions to help meet the demands of this challenging environment, while adhering to the guidance outlined above. These include:
Ensuring that your patients remain safe and enrolled in studies is pivotal, and we all need to do our part and stay committed to ensure that we help sites meet trial goals.
Pete Tarasov is the Senior Director, Quality Assurance & Regulatory Compliance at Greenphire.