NCATS Director's Message: Clinical Trials, Today and Tomorrow

From Joni L. Rutter, PhD — Director, National Center for Advancing Translational Sciences | This Director's Message is part of a series on how NCATS tackles persistent problems in translation.

In January, NIH Director Monica Bertagnolli, MD, joined our advisory council meeting for a robust discussion of her priorities, including new approaches to clinical research to improve people's health. We talked about barriers to clinical research, such as lack of trust and trustworthiness, access, and education, as well as the need to get the results to health care settings where they can be used.

Dr. Bertagnolli noted that NCATS is on the forefront of solving challenges like these, and indeed we are.

Our two clinical research networks — the Rare Diseases Clinical Research Network (RDCRN) and the Clinical and Translational Science Awards (CTSA) Program — have been leaders in engaging patients and communities through the entire research process. They focus on different aspects of clinical trial site readiness. The RDCRN strives to de-risk clinical trials for rare diseases. It conducts disease research and natural history studies and works with patient advocacy groups. The CTSA Program offers clinical research expertise, resources, and training. Its partnerships enable a local, regional, and national response to public health needs.

A recent paper summarizes RDCRN's 20 years of contributions in this space. Here, I'll focus on three aspects of clinical trial site readiness that the CTSA Program addresses. Its solutions showcase translational science principles in action, particularly finding generalizable solutions and promoting diversity, equity, inclusion, and accessibility (DEIA).

Managing Multisite Trials

Multisite trials can recruit faster and offer larger and more diverse samples, which help ensure that results apply to all who could benefit from a new medicine. However, planning, launching, and running these trials is complex and can take a long time. CTSA Program leaders and other experts published a framework for assessing clinical trial site readiness. This paper and a companion piece emphasizing DEIA can help clinical trial sites be at the top of their game.

Read more at ncats.nih.gov »