CROs embracing tech to decentralize trials and speed enrollment as regulators show support 'with their feet'

Demand for faster enrollment and growing use of decentralized trials model are increasing use of management tech in clinical development, according to Florence Healthcare.

The conclusion comes from a survey of nearly 200 research professionals quizzed by the software firm about trends in the drug development space, which revealed that tech is being used to solve recruitment bottlenecks and reduce admin, says Florence CEO Ryan Jones.

“The shift away from paper is all about allowing research teams to focus on enrollment instead of administrative work. When teams move from paper to digital processes, three things happen: automation, de-duplication, and intelligence," Jones said. “If all administrative actions happen in the digital realm, reporting and tracking becomes seamless. The outcome of these three things is that administrative overhead and time is cut by about 40%. In one example, a customer told us that startup signature timelines went from two weeks to three hours.”

The survey also touched on novel study types with 89% of respondents reporting they use elements of decentralized clinical trials in their research.

The interest in decentralized elements also reflects changes in regulatory oversight of the trials sector, Jones added. He cited FDA backing for things like electronic investigative site files as an example. Regulators from the FDA and the U.K.'s Medicines and Healthcare products Regulatory Agency have even logged into these site file systems to conduct inspections and remotely monitor studies. 

“Post-COVID site monitoring methods have changed, and the agencies have been supportive of this change in order to allow progress to continue in a remote world," Jones said. "In a sense, they've voted their support with their feet.”

However, while decentralized trials address some of the challenges facing the pharmaceutical industry, the future of clinical research is likely to see more hybrid site and home-based studies, says Jones.

“[Decentralized clinical trials] are important because they supplement enrollment, but clinical sites will always be the heart of studies because that's where patient care happens," he said. "This is especially true in complex diseases like cancer. In the clinic, where physicians and nurses are busy, time is the most precious commodity, and quality can't be compromised.”

The need to connect site- and home-based elements of trials is an opportunity for technology developers, Jones says, citing his firm’s partnership with Science 37 as an example.