Based on recent SCRS survey data, a vast majority of research sites (58%) anticipate that COVID-19 will negatively affect their clinical trial enrollment and nearly half of respondents (47%) feel COVID-19 will have a negative effect on retention. With the number of new cases increasing daily, these expectations are, unfortunately, likely to be correct.
Sponsors and sites will need to be resourceful over the coming months to keep ongoing trials running and avoid delays in new study starts. As always, the first priority must be patient safety and minimizing risks to trial integrity. Not all trials will be able to modify protocol and proceed, however, there will be trials where protocol amendments will be applicable to keep studies on track.
The CDC and the President recently suggested the use of telemedicine services, paving the way to take full advantage of decentralized clinical trials (DCTs) where appropriate. The FDA has released guidance on conducting clinical trials during the COVID-19 pandemic.
Take Action Now
We heard from industry leaders, even before COVID-19 jolted nations around the globe, that there was likely a tsunami of DCTs on the horizon. This unprecedented pandemic has now increased that likelihood many times over. Prepare now so your site can help with immediate needs and be ready for future demands.
Prepare for a surge in decentralized trials:
- Read the FDA guidance documentation
- Read highlights from the FDA guidance document as it relates to virtual visits
- Take the Virtual Trial Capable training
- Get support modifying study protocol to include virtual visits
- Learn about virtual pre-site study visits
- Remote assessment and monitoring services avoid delays in new study starts