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Streamlining Multisite Clinical Trials

NCATS SMART IRB Reliance Platform to serve as roadmap for new NIH policy.

Work with Us

NCATS aims to address common barriers in clinical and translational research that scientists nationwide face every day, with the goal of delivering more treatments to more patients more quickly.

Contact the Division of Clinical Innovation (link sends e-mail)

Clinical Innovation

NCATS supports innovation in new technologies and other clinical and translational approaches that may greatly accelerate the process of transforming laboratory discoveries into new treatments for patients. b

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Clinical & Translational Science Awards (CTSA) Program

The CTSA Program is designed to strengthen and support the entire spectrum of translational research from scientific discovery to improved patient care.

Rare Diseases Clinical Research Network (RDCRN)

The RDCRN is designed to advance medical research on rare diseases by facilitating collaboration, study enrollment and data sharing.

Patient Registries

Patient and contact registries are key tools that help researchers identify potential clinical study participants, including health volunteers.

Clinical Research Toolbox

NCATS supports clinical research tools that facilitate trial design, patient recruitment and partnerships for commercialization.

Clinical Trials

NCATS programs support a broad range of clinical research, including clinical trials. NCATS authorization (PDF - 133KB) limits specific support for clinical trials only through the end of Phase IIA.

Phase II clinical trials are designed to test drugs for efficacy (or effectiveness) and side effects in a limited number of patients. Phase IIA trials provide data for exposure-response in patients, while Phase IIB trials provide data for dose-ranging in patients.

Addressing Clinical Research Challenges

Researchers nationwide face common barriers in clinical and translational research that can delay the development of new interventions for patients in need. These challenges include:

  • Difficulties in recruiting, mentoring and retaining a critical mass of qualified clinical and translational investigators
  • Increased research costs and complexity
  • Low patient recruitment and retention in clinical research studies
  • Inflexible study designs
  • Increased regulatory burdens

NCATS supports innovative programs, such as the Clinical and Translational Science Awards (CTSA) Program and Rare Diseases Clinical Research Network (RDCRN), to help address these challenges.