As the evolving COVID-19 pandemic continues, the clinical trial community and regulatory agencies have taken extraordinary measures to mitigate the negative effect the virus has on the conduct of clinical trials. In response to the pandemic, the FDA and EMA drafted guidance on the actions that sponsors of affected clinical trials should take to help ensure the integrity of their studies, and the interpretation of the study results, while safeguarding the safety of trial participants as a first priority.
COVID-19 Research Resources HubAll | Association, Society, and Collaborative Group Portals | COVID-19 Trial Registries | Funding Opportunities | Government, Regulatory Portals and Guidance | Tools and Instruments | Webinars
3 Webinars Resources
- April 15, 2020
The COVID-19 outbreak has implications for ongoing research with millions of people currently participating in clinical trials...
- March 20, 2020
- Susanna Naggie, MD; Adrian Hernandez, MD, MHS; Eric Perakslis, PhD
This week, stakeholders from across the clinical trials ecosystem submitted experiences and insights related to the FDA’s new guidance on the conduct of clinical trials of medical products during the current COVID-19 pandemic. The Clinical Trials Transformation Initiative (CTTI) collated the feedback – including insights safety considerations, remote study visits, remote consent, consulting with IRBs, and more – and will share the findings and best practices via a webinar on Tuesday, March 31 at 11:15 a.m. ET.
- Event has already occurred
- Clinical Trials Transformation Initiative (CTTI)