Whitepapers

Today’s clinical studies are increasingly complex and require patient-centric trial designs, like decentralized trials, more than ever before. As trials incorporate more decentralized components there is an ever-present need for multiple system integrations to support the various trial functions, with the goal being that all trial data flows seamlessly between systems and is stored in one repository for efficient oversight and analysis. These numerous integrated systems require closely managed integration, synchronization, and supportive partnerships to minimize error and maximize efficiency. In this case study, partners endpoint and THREAD dig-in to explore how IRT can be integrated with decentralized clinical trial (DCT) technology, working through tightly integrated workflows, to provide a streamlined process, a better user experience for Sites and Participants, higher quality data and real-time access to information.

On May 1, 2023, the U.S. Food and Drug Administration (FDA) released an updated Draft Guidance on decentralized trials. This release shows that the landscape of clinical research is rapidly evolving. The shift towards decentralized clinical trials presents an exciting opportunity for sponsors to improve patient engagement, enhance data quality, and accelerate clinical research. Are you prepared for what’s to come? Download the insight brief to learn more.

The pending FDA Guidelines is clear—pharma companies must improve diverse representation in clinical trials. In this whitepaper, Science 37 shares tips and strategies on how to achieve diversity in clinical trials.

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.