The US Biomedical Advanced Research and Development Authority has selected Cary, North Carolina-based CRO Allucent as partner for its decentralized trial medical countermeasure development program.
Participation in the D-COHRe program will see Allucent build capacity for decentralized trials to support development of medical countermeasures (MCMs).
The contract research organization (CRO) will enhance its capabilities to deploy decentralized clinical trials, including hybrid and fully decentralized trials using home health, mobile health, telehealth and alternative research sites.
These diverse site models will be supported by secure data collection technology, engagement tools for participants, and numerous research services to facilitate the enrolment and retention of diverse and dispersed research participants.
The aim is to bolster the US’s ability to prepare and respond to future public health emergencies.
CEO Mark Goldberg said “In the wake of the COVID-19 pandemic there is a pressing need and an unprecedented opportunity to realize the potential of decentralized clinical trials.”
This project has been funded by BARDA’s division of research, innovation and ventures under agreement number: 75A50124C00025, which is valued at up to $4 million.
Allucent’s core decentralized trial technology – which was launched in 2023 – was built in partnership with Thread, a DCT and eCOA technology provider to CROs and the drug industry.
COVID contacts
The contract coms just a few months after BARDA hired Allucent to run a decentralized trial of a vaccine against SAS-CoV-2, the virus that causes COVID-19.
At the time the CRO said the program – which is being funded to the tune of $25.5 million through the Rapid Response Partnership Vehicle (RRPV) consortium - would be a 4,000-participant decentralized Phase IV observational study.
Similarly, in August 2023 BARDA hired Allucent to accelerate clinical research and development for next-generation COVID-19 booster vaccine candidates. Under that programme the CRO initiated and implemented a 10,000-participant Phase IIb clinical trial.
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