- Global Cross-Industry Collaboration Releases First Deliverable from Portfolio of Initiatives -
SAN DIEGO, Nov. 10, 2022 (GLOBE NEWSWIRE) -- The Decentralized Trials & Research Alliance (DTRA), a non-profit organization dedicated to the global adoption of decentralized clinical trials and research within life sciences and healthcare, today announced several key initiative updates that will continue to progress throughout 2023. Specialized DTRA teams presented these initiatives during its 2nd Annual Meeting in Boston, MA, from November 6-9, 2022. The meeting was attended by select professionals from its global membership of leaders in decentralized clinical trials (DCTs) including regulators, pharmaceutical and biotechnology sponsors, contract research organizations (CROs) and other service providers, technology companies, research sites, and advocacy leaders.
“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.”
Key themes included:
- Defining What Is a Site in 2023: Leaders from Care Access, CenExel, Circuit Clinical, CVS, Parexel, Sanofi, and Science37 explored the evolution of the site model coming out of the pandemic and where it is headed in the coming years. This panel identified and challenged areas of modernization still needed in order to ensure that research infrastructure is keeping pace with innovation in the field.
- Pathways for Global Regulatory Clarity and Harmonization: Leaders from FDA, EMA, Danish Medicines Agency and Israel Ministry of Health came together to describe the current state of acceptability of DCTs at global scale. The panel explored expectations for upcoming regulatory guidance for DCTs, and where there are opportunities to enhance harmonization.
- Executing on the Mission in a Challenging Market: Strategies for sustaining delivery despite the challenging economic market was discussed by leaders from BMS, Datacubed Health, Medable, Medidata, and THREAD. They also explored where shifts in priorities are needed given the convergence of the pandemic, recession and great resignation.
“As the presentations at the Annual Meeting of DTRA have demonstrated, we are making great progress on all our announced initial Initiatives, driven by our member-identified priorities,” said Dr. Amir Kalali, Co-Founder and Co-Chairman of DTRA. “This is just the beginning of our work, and I look forward to DTRA delivering more products in 2023 that enable the whole field to provide wider access for patients.”
Priority Initiatives that will be ongoing by DTRA:
- Global Acceptability of DCT Methods: The Regulatory Gaps team is using the trial lifecycle framework to assess where regulations are clear or ambiguous about using DCT methods. This is being digitized with links to the current guidance documents and references.
- Trial Conduct Impact: 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.
- Data Technology: A consistent theme at the Annual Meeting included how to ensure that data from DCTs will meet regulatory expectations. 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.
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.