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NCATS Report Highlights Decentralized Clinical Trials’ Challenges, Opportunities

June 10, 2024

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Senior adult using online videoconference with doctor for telemedicine and telehealth. (Shutterstock)

The COVID-19 pandemic increased the push for novel clinical trial designs to broaden participation and deliver real-world research findings sooner. A new report from NCATS offers ways to strengthen and expand one such design: decentralized clinical trials (DCTs).

Typically, trials are run in medical research centers and centralized locations. DCTs use technology and community partners to reach participants and run trials beyond traditional sites. DCTs could make clinical trials more efficient, effective and equitable. That could bring more treatments to all people more quickly. NCATS-funded Clinical and Translational Science Awards (CTSA) Program institutions have long-standing expertise in DCTs. They have used the DCT model in such clinical trials as the ACTIV-6 trial, which has tested evidence-based outpatient treatment options for COVID-19.

“To address critical areas in the advancement of DCTs, we first need to find out what’s being done, what’s working well, and what challenges and needs exist in the development, deployment and dissemination of DCTs,” said Christopher Hartshorn, Ph.D., chief of the Digital and Mobile Technologies Section in NCATS’ Division of Clinical Innovation.

To this end, NCATS asked for community input on DCTs. The resulting report outlines challenges to starting DCTs and steps to improve their uptake. Responders offered feedback on seven key factors for building successful decentralized studies:

  • Resources, infrastructure and enabling technologies: DCTs should ensure that all trial participants can access the needed technology. People and communities that are not typically involved in trials may need support to effectively use the technology. That includes broadband access and mobile technology training and technical support.
  • Community engagement: DCTs can bring new participants into clinical trials. This may include people with low socioeconomic status or who live in rural areas. But researchers must work with communities to design trials that meet community values, goals and needs. Returning trial results to participants and communities is also key to boosting public trust in research.
  • Workforce development: Researchers and staff should be trained in skills specific to DCTs. Those skills include managing data and using mobile technology. Participants and community health workers and leaders, who are vital to community involvement and trust, also need such training.
  • Partnerships and collaborations: Researchers must build relationships with organizations and groups that are not part of standard clinical trials. That can mean working with community hospitals, primary care providers, pharmacies and rural health clinics. Those partnerships can bring a study closer to its participants.
  • Study participation and adherence: Researchers and sponsors should provide technical and troubleshooting support to DCT participants, caregivers and family members who use technology as part of a study. Studies should avoid burdening participants with requests for data that can be obtained in other ways, such as through electronic health records.
  • Privacy and security: DCT researchers should make the study consent or withdrawal process as user friendly as possible. Data authentication methods should be tailored to participants’ different levels of technological skill.
  • Data: DCTs and the technologies used could produce huge amounts of data. Data quality, integration, analysis and sharing are key to DCT reliability and reproducibility. DCT designs must consider the balance between data to be collected and storage and processing limits.

“We want to engage more people in research by lowering the barriers to participation in studies through decentralized clinical trials,” said Michael G. Kurilla, M.D., Ph.D., director of NCATS’ Division of Clinical Innovation. “The CTSA Program institutions have the necessary expertise, resources and infrastructure to optimize the impact of DCTs and derived data, and to advance clinical and translational science to benefit more people.”

Learn more about the report, “Advancing Clinical and Translational Science through Accelerating the Decentralization of Clinical Trials.”

 

Last updated on June 10, 2024