PCM Trials

Jon Ernst (Vice President, In-Home Solutions, Decentralized Clinical Trials) discusses today's clinical trial landscape.

In March 2024, the US FDA issued its guidance, “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” outlining the agency’s objectives for protecting public health as artificial intelligence (AI) and other technologies become more prevalent in healthcare.

Webinar Date/Time: Wed, Mar 27, 2024 11:00 AM EDT

Webinar Date/Time: Tue, Nov 14, 2023 11:00 AM EST

Decentralized trials (DCTs) have grown in acceptance since the COVID-19 pandemic when mobile research nurses were asked to step in to save hundreds of site-based clinical trials at risk of being postponed or cancelled because of mandated lockdowns. But despite their proven effectiveness, DCTs are still often an afterthought or an add-on option to site-based trials due to cost concerns The perception has been that deploying mobile research nurses to visit patients at their own homes would be more expensive than site-based trials. However, a recent study by the Tufts Center for the Study of Drug Development (Tufts) shows that not only are DCTs more patient-centric, but they also provide comparatively high returns on investments for sponsors.

With innovations in wearables, digital monitors and video capabilities, technology can play a role in efficiently capturing data in decentralized clinical trials. Technology alone often is not enough, however, especially considering the diverse and vulnerable populations who participate in clinical trials. Human intervention by properly trained medical professionals such as mobile research nurses is key to ensuring data consistency and integrity as well as protocol compliance. Given the bond that often forms between patients and their caregivers, mobile research nurses also can help improve patient retention.

Webinar Date/Time: Thu, Jan 26, 2023 11:00 AM EST

Whether used exclusively or as part of a hybrid approach, patient-centric decentralized clinical trial methods enable investigators to more easily recruit and retain a diverse patient population. DCTs cannot, however, yield their full spectrum of advantages without proper planning and attention to detail. This checklist can help guide sponsors and CROs toward a successful trial.

There is a growing body of evidence that hybrid and decentralized clinical trials are here to stay. What was once a nice-to-have is quickly transforming into a must-have. The catalyst for this dramatic shift was the COVID-19 pandemic. To aid sponsors and CROs in fully realizing the benefits of decentralized clinical trial methods moving forward, this whitepaper extracts the lessons learned from the pandemic and their implications for clinical trials now and in the future.