It’s looking more and more like the so-called “COVID catalyst” inspiring faster adoption of technology and virtual components in clinical trials is the real deal. The latest evidence: a new analysis by the Tufts Center for the Study of Drug Development (CSDD).
Noting that 55% of active ongoing clinical trials have transitioned to remote and virtual execution models since early spring, Ken Getz, professor and deputy director of Tufts CSDD, said the appeal of these decentralized approaches “is compelling.”
“Among other benefits, decentralized trials have provided increased convenience and minimized coronavirus transmission risk for study volunteers, while offering drug developers potentially lower costs and faster access to scientific and operating data,” Getz said.
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Getz cautioned, however, that decentralized clinical trials introduce a number of challenges, including those associated with remote communication and remediation, and data coordination and integration.
The analysis, based on global surveys of investigative sites and interviews with representatives of the largest pharmaceutical companies, was summarized in the November/December Tufts CSDD Impact Report, released today (November 12).
Other key findings from the analysis include the following:
- Telemedicine is the most frequently used approach to conducting decentralized clinical trials.
- Leaders of investigative sites conducting remote trials rate patient safety as their greatest concern.
- Sixty percent of investigative sites report having had no prior experience with remote processes and solutions before the pandemic.
- For many developers, particularly at smaller companies, contract service organizations have been the primary provider of remote monitoring personnel and capabilities.
Edited by Michael Causey