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The Clinical Trials Industry’s Weekly News Update

DTRA points to regulations, infrastructure, and tech as keys to DCT growth

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Continued growth of the decentralized trial sector will depend on how the regulatory environment and research infrastructure evolve over the next few years according to industry group, DTRA.

The Decentralized Trials & Research Alliance (DTRA) – a group whose members include drug developers and CROs – spoke about the development of the remote clinical trials industry post-COVID after its AGM last month.

“The life science industry is at a critical juncture in the adoption of decentralized research methods and the urgency to reduce the remaining barriers to global adoption will remain the cornerstone to our mission at DTRA,” said Craig Lipset, co-founder, and co-chairman of DTRA.

“Our meeting convened some of the best minds in decentralized clinical trials and, together, with the global regulatory community, we will continue to expose barriers to scale and will work together to address these gaps.”

Experts convened at the meeting identified modernization of trial sites to “ensure that research infrastructure is keeping pace with innovation in the field” as one of the keys to growth of DCT trials.

They also suggested enhancing the harmonization of regulations covering decentralized clinical trials should be another focus for companies and CROs involved in remote drug studies.

Advocacy efforts

The DTRA also outlined how it plans to promote decentralized trials, explaining that its so-called “evidence of impact team” would be key.

“The evidence of Impact team has conducted extensive research across stakeholder groups and publications to identify and quantify DCT impact in trial conduct.

“This body of evidence will grow as more trials are completed, and as the key performance indicators are applied by project teams to measure operational outcomes of DCT methods.”

The industry group also said it would work with technology suppliers to help standardize the systems used to run remote studies, pointing to work groups it established this year.

“Two initiative teams are actively working to help address this need by creating a framework for data collection and interoperability for studies using DCT methods.”

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