In February, the European Medicines Agency (EMA) released the fourth version of its Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic. As the pandemic continues to impact clinical research worldwide, these updated guidelines reflect the EMA’s evolving stance, clarifying questions raised by previous versions and taking into account the most recent changes in the global health landscape. Here’s an overview of what’s new.
Expanded use of remote source data verification
The primary change is to the EMA’s recommendations for the use of remote source data verification (rSDV). Previously, the guidance stated that rSDV be considered only in limited circumstances for trials involving COVID-19 treatment or prevention or during final data cleaning before database lock in pivotal trials for serious or life-threatening conditions with no satisfactory treatment. The new version expands the list of circumstances in which rSDV can be justified, including:
- When the absence of SDV for critical data is likely to pose unacceptable risks to participants’ safety or reliability/integrity of data results
- Trials involving especially vulnerable participants such as children or those temporarily or permanently incapable of giving informed consent
- Any pivotal trials
The guidance still notes that remote SDV should only be considered during the COVID-19 public health crisis and when in line with EU and national law (or temporary national emergency measures). In light of its expanded recommendations, however, the EMA notes the importance of adequate data protection and security measures whenever rSDV is used. The principal investigator’s institution and the sponsor may be jointly responsible as controllers for ensuring this information is safeguarded in accordance with the General Data Protection Regulation (GDPR), including ensuring that an appropriate transfer tool is in place when data is transferred/processed outside of the European Union or European Economic Area.
Recognition of the increasing value of centralized monitoring
The new revisions highlight the role that centralized monitoring as defined under ICH GCP E6. 5.18.3 (Addendum) has played during the pandemic. The guidance also draws a clear distinction between centralized monitoring, which refers here to additional remote monitoring capabilities that can supplement and/or temporarily replace on-site monitoring, remote SDV as described above. Adopting centralized monitoring and other technologies has added layers of complexity to the planning and processes required to ensure data quality. The use of apps, ePROs, and wearable devices may increase patient convenience, provide real-time data, and reduce site burden. Still, it may also require different approaches for collecting and managing data and complying with evolving regulatory guidance. Implementing technologies such as eConsent may involve additional training and technical considerations.
Addressing the challenges facing clinical research today – and the questions that still remain
Our cross-functional COVID-19 Task Force is continuously monitoring the latest regulatory changes and adapting our best practices to ensure trial continuity for our sponsors. The new EMA guidance provides a valuable resource for conducting clinical research during the pandemic, but there are still many unanswered questions regarding how these innovative approaches will continue to impact the industry in the future.
With our commitment to helping biotech and specialty pharma companies optimize limited resources to deliver conclusive results, we are uniquely positioned to help you manage the uncertainty of the evolving clinical research landscape. Contact us to schedule a meeting with our team today.
Senior Vice President, Clinical Development EMEA & APAC