Government Agencies Emphasize the Importance of Decentralized Methodologies for Future of Clinical Research

Decentralized Trials & Research Alliance brings together Global Leaders for its Annual Meeting

SAN DIEGO, Nov. 08, 2023 (GLOBE NEWSWIRE) — The Decentralized Trials & Research Alliance (DTRA), a global alliance focused on the adoption of decentralized trials, today concluded its 2023 Annual Meeting, including members from biopharmaceutical companies, government agencies, research sites, healthcare organizations, patient groups, and service and technology companies.

Leaders from the U.S. Food & Drug Administration (FDA), National Institute of Health (NIH), Office of the National Coordinator for Health IT (ONC), Biomedical Advanced Research and Development Authority (BARDA), and the European Medicines Agency (EMA) shared updates on sustaining decentralized research adoption. The DTRA community learned of their strategic intentions regarding decentralized clinical trial (DCT) adoption, drivers to achieve scale with these methods, and the importance of DCT to our research ecosystem.

“Regulatory ambiguity has been a hurdle to the adoption of decentralized clinical trials, and the DTRA community was particularly pleased to hear directly from these key stakeholders,” shared Dr. Amir Kalali, Co-Founder and Co-Chair of the DTRA. “Government agencies share the commitment to decentralized trial methods and consider them a vital strategy for improving resilience in the face of future health threats.”

More than 315 professionals from DTRA member organizations have been working together since the organization’s formation in 2020 to identify and address the barriers to more widespread adoption of decentralized clinical trials (DCT) in medical research. DTRA has harnessed this industry-leading expertise into creating new resources, sharing key learnings, and establishing best practices for research teams to use in implementing DCTs. In addition, 12 initiatives, based on priorities set by the DTRA Leadership Council, have now delivered their outputs.

Leaders from the DTRA community took the stage throughout the meeting to share their deliverables in the plenary sessions. These solutions are housed within the interactive DCT Tubestop Map, which was used as a framework for the session. This map is a digital end-to-end process guide to support DCT trial planning and execution, with key steps across the planning, setup, conduct, and close stages of trials. Attendees took a journey through the map to learn more about areas such as patient input to protocol design, data flow planning, regulatory conduct differences. A highlight of the Tubestop is the inclusion of resources created by partner organizations (including ACRO, ACRP, CTTI, SCRS, Transcelerate and others).

“It’s fulfilling to see our vision become a reality and to make this available to the research community,” said Jane Myles, Program Director for the DTRA. “Each of our Initiative outputs is available at www.dtra.org and the resources are available to all.”

ABOUT DTRA:

The Decentralized Trials & Research Alliance (DTRA), a non-profit organization, was convened to enable collaboration of stakeholders to accelerate the adoption of patient-focused, decentralized clinical trials and research within life sciences and healthcare through education and research. It works to make research participation accessible to everyone, enabled by the consistent, widespread adoption of appropriate decentralized research methods. Follow DTRA on Twitter and LinkedIn for more information.

For further information please contact:

Media Contact:
Glenn Silver
Lazar – Finn Partners
glenn.silver@finnpartners.com
973-818-8198

Membership Inquiries:
DTRA Secretariat
secretariat@dtra.org
619-209-7371