Decentralized trials are staying put, but sites and sponsors aren't quite prepared: survey

Decentralized clinical trials became commonplace during the pandemic as companies scrambled to maintain research when in-person contact was precarious and, at times, dangerous. A new report has found that while most sites and sponsors plan to continue some DCT strategies, many aren’t prepared to fully integrate every aspect of the available new tech. 

The survey, conducted by Florence Health, found that on a scale of 10, trial sites' confidence level for managing DCTs was five. The confidence level among sponsors was not much higher, coming in at six. The trepidation comes as 89% of sponsors indicated they use elements of DCT in at least some of their studies. 

One contributor to the diminished confidence is navigating the numerous forms of technology that both sites and sponsors need to adopt in order to maximize flexibility. For example, only 68% of sites use telemedicine in their operations, highlighting a divide in adopted technology that limits the industry as a whole.

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Other tech, like electronic regulatory platforms, is much more commonplace, with 89% of sites now using them. According to the survey, integrating other technology and budgetary concerns topped the reasons sites didn’t adopt new technology.

But some companies are looking to address just that. Medidata, which partnered with Moderna during clinical trials for its COVID-19 vaccine, launched a decentralized clinical trials program in June 2021. The software provider touts the program as allowing access to “participant data remotely from anywhere, at any time.” The company says the technology has been applied to more than 44,000 sites worldwide.

Some larger pharmas, like Merck, took it upon themselves to decentralize trials during the pandemic. When COVID struck, the company’s global clinical trial operations team worked with trial sites to get remote access to digital records. The team also sent visiting nurses to patients, operating almost like a mobile trial site. 

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The trend appears to be catching on. According to the survey, almost every piece of technology associated with DCTs is likely to see a sizable jump in adoption over the course of the next year. The one that has the most disconnect is telemedicine, with 68% of sponsors planning to invest in the technology over the next year, a number that jumps to 86% among polled sites. 

Moving forward, the survey found that for trial sites, it’s critical that sponsors and CROs adopt and are trained to use the software sites have at their disposal. Sites also expect partners to utilize remote-based monitoring.