COVID-19 has changed the way people consult with their physicians and it is also likely to change the way clinical trial participants conduct study visits.
The coronavirus crisis has the potential to encourage trial sponsors to find ways to keep participants at home and accelerate the adoption of decentralized or virtual trials.
The U.S. Food and Drug Administration (FDA) has issued new guidance on conducting trials that require sponsors to prioritize patient safety and mentioned phone calls and virtual visits as ways to keep trial participants safe.
The best option for sponsors to keep patients safe is to reduce the required physical study visits and replace them with televisit and remote monitoring.
Clinical Innovation Partners founder Craig Lipset and Patients Can’t Wait president Jeff Kasher both feel that there may be something positive to the challenges to clinical trials caused by COVID-19.
Lipset sees potential changes in telemedicine but says it is important to ensure that the right changes persist and outlast COVID-19.
Kasher wants to see the insertion of more virtual components into clinical trials, the reduction in patient protocol and the distribution of investigational drugs to pharmacies and homes.
3 KEY POINTS
“If one good thing emerges from this pandemic, it will be the use of remote/centralized monitoring in all clinical trials. Regardless of the cause, in 2020 we cannot have monitoring of ongoing trials compromised for any reason,” says Jeff Kasher, president of Patients Can’t Wait.
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