Request for Information on the NICHD Vision for Multisite Clinical Trials Infrastructure

Notice Number: NOT-HD-19-041

Key Dates
Release Date: November 08, 2019
Response Date: December 20, 2019

Related Announcements
None

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

Purpose

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is soliciting input from the public on its vision for supporting multisite clinical trials infrastructure. Support of rigorous clinical trials is a key component of the implementation of the recently released NICHD Strategic Plan 2020.

Background

NICHD is committed to providing critical infrastructure support for multisite clinical trials that involve populations of key relevance to its mission (e.g., women, neonates, and children). This includes infrastructure for multisite trials in its extramural and intramural programs. Additionally, NICHD is committed to completing currently active protocols as designed in all existing NICHD-funded networks.

NICHD’s mission is to lead research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. In September 2019, NICHD released its Strategic Plan 2020, which comprises scientific themes, aspirational goals, and objectives for scientific stewardship, program management, and accountability. The conduct of rigorous multisite clinical trials, both intramurally and extramurally, will serve a key role in the implementation of the strategic plan.

In a webinar on November 1, 2019, NICHD described its vision for the support of multisite clinical trial infrastructure, built around four guiding principles:

  1. Enhancing rigor and reproducibility
  2. Promoting greater availability of infrastructure
  3. Facilitating data sharing and access to biospecimens
  4. Facilitating greater involvement of diverse populations in multisite clinical trials

NICHD is actively exploring mechanisms that incorporate these guiding principles to support multisite clinical trials infrastructure as a means of accomplishing its scientific goals, both intramurally and extramurally. Two potential approaches to supporting multisite clinical trials are a central resource model and a consortia model, but there is no “one size fits all” approach.

Information Requested

NICHD invites the research community, health care professionals and professional organizations, patient and family advocates, and interested members of the public to provide comments and input on its vision for support of multicenter clinical trial infrastructure.

Specifically, NICHD seeks comments and suggestions on the following plans and opportunities:

  • Additional guiding principles that may inform support for multisite clinical trials to advance the NICHD mission
  • Additional considerations or approaches NICHD should consider as it determines the methods by which it will support multisite clinical trials and infrastructure
  • Any other input relevant to the NICHD vision for support of multisite clinical trial infrastructure

How to Submit a Response

All responses are voluntary. Responses will be accepted until December 20 , 2019, and must be submitted by email to NICHDClinicaltrialsRFI@nih.gov.

The submitted information will be reviewed by NICHD and used at its discretion. Respondents are advised that the government is under no obligation to acknowledge receipt of the information provided and will not provide feedback to respondents. This RFI is for planning purposes only and should not be construed as a solicitation for applications or proposals, or as an obligation in any way on the part of the U.S. government. The government will not pay for the preparation of any information submitted for the government’s use. Additionally, the government cannot guarantee the confidentiality of the information provided.

Inquiries

Please direct all inquiries to:

Caroline Signore, MD, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development
Telephone: 301-496-5577
Email: signorec@mail.nih.gov