EFPIA welcomes 28 April 2020 publication of the revised EMA guidance on the management of Clinical Trials during COVID-19 pandemic. 

As an industry, we are working tirelessly to ensure that the impact of COVID-19 on clinical trials is mitigated as far as possible. We are grateful for the updated guidance from European Regulators that will help support these efforts. The pandemic has instigated a host of challenges to conducting clinical trials such as quarantines, site closures, travel limitations, disruptions in supply chain for investigational and ancillary products and infection of trial investigators and patients. All of these challenges may lead to participants discontinuing in the trial, protocol deviations and missing data risking the integrity of trials, which threatens to devalue the considerable investment by patients, investigators, healthcare organisations and sponsors.

The revised guidance includes recommendations to ensure distribution in clinical trials of Investigational Medicinal Products (IMPs) directly to patients to protect safety and well-being of trial participants. The document also includes more detailed information on remote monitoring and source data verification (SDV). The verification of the raw data in hospitals can be difficult during the pandemic due to the social distancing limited resources at trial sites. In addition, the guidance provides more detailed instructions on how sponsors should communicate with authorities in case urgent actions are needed to protect trial participants against any immediate hazards or other changes that could affect patient safety or data integrity.

The revised guidance document aims to provide a harmonised, EU-level set of recommendations for managing ongoing trials during the current pandemic. EFPIA’s overarching request to the EU and Member State Competent Authorities is to continue to seek alignment across all EU countries on the necessary flexibilities for the conduct of clinical trials and the means to manage data integrity. This would ensure that these trials are not wasted opportunities to advance healthcare for the future.

Due to the rapidly evolving situation, EFPIA welcomes the opportunity to keep the dialogue open with European regulators on this topic and will continue providing input when further updates to this guidance are being discussed.