Notice Number: NOT-HD-19-034

Key Dates
Release Date: October 10, 2019

Issued by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Purpose

NICHD is committed to providing critical infrastructure support for multisite clinical trials that involve populations of key relevance to our mission (e.g., women, neonates, and children). Most of this support is provided through extramural grants and contracts to networks of clinical sites. The NICHD intramural program also supports infrastructure for multicenter clinical studies, which includes the NIH Clinical Center in Maryland, the NICHD-supported Perinatology Research Branch in Michigan, and networks managed by investigators in the NICHD Division of Intramural Population Health Research. Together, this support has yielded significant public health impact by generating thousands of research publications, training hundreds of professionals in conducting high-quality clinical trials, and directly informing clinical practice guidelines.

The NICHD Strategic Plan 2020 was published in September 2019. It articulates scientific themes, aspirational goals, and priorities for scientific stewardship, management, and accountability. The plan sets out the fundamental components that NICHD will use over the next five years to shape and support science relevant to our mission.

To accomplish many of the scientific priorities noted in the plan, NICHD will continue its commitment to infrastructure support for rigorous multi-site clinical trials, both intramurally and extramurally. To do so, the institute will need to align its efforts with widely accepted principles that are shaping the 21st century scientific landscape of NIH-supported research. These include:

• Enhancing the rigor and reproducibility of clinical trial protocols. NICHD is committed to this trans-NIH goal, and will ensure that multisite clinical trial protocols are submitted through the peer review process and that NICHD staff members have the tools to provide oversight of milestone planning, progress review, and ongoing risk management. This effort will include the identification of methods to minimize staff exposure to real and perceived conflicts of interest, ensure stewardship of public funds, increase accountability, and maintain public trust.
• Promoting greater availability of multisite clinical trial infrastructure to support trials from a wider range of investigators. Maximizing the availability of research resources facilitates open access and potentially enhances fair competition. NICHD invests in the training of well-qualified, clinically trained scientists with many innovative ideas. The institute will find ways to make vital infrastructure for multisite clinical trials more available to the research community to help secure its continued growth.
• Facilitating data sharing and access to biospecimens to efficiently expand research capacity for all investigators. This effort will maximize NICHD’s infrastructure investment by promoting secondary analysis, reproducibility of results, and enhanced data/specimen aggregation and sharing. Incorporating FAIR principles and enhancing data harmonization will allow NICHD and the scientific community to capitalize on artificial intelligence and other enhanced analytic techniques. These principles are becoming the gold standard across NIH, and NICHD will incorporate them to better address the public health needs of its populations.
• Facilitating greater involvement of diverse populations in multisite clinical trials. Health disparities and inclusion in clinical trials are significant concerns for the populations and conditions that are priorities for NICHD. Infrastructure for multisite trials needs to reach racially and geographically diverse populations to advance our scientific mission.

NICHD is actively exploring grant and contract mechanisms that help incorporate these four principles and enhance its strong commitment to multisite clinical trials infrastructure, both intramurally and extramurally. You are encouraged to join NICHD Director, Dr. Diana Bianchi, on November 1st at 2:00 pm EST for an interactive webinar, Strategic Plan 2020 Implementation: NICHD’s vision for multi-site clinical trials infrastructure , which will provide an overview of these issues and an opportunity for questions and comments. Information about accessing the webinar will be posted on the NICHD website.

Inquiries

Please direct all inquiries to:

Caroline Signore, MD, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-5577
Email: [email protected]