Notice of Intent to Publish a Funding Opportunity Announcement for Reproductive Medicine Clinical Trials Program (R01 Clinical Trial Required)

Notice Number: NOT-HD-18-012

Key Dates

Release Date:July 03, 2018
Estimated Publication Date of Funding Opportunity Announcement: 09/14/2018
First Estimated Application Due Date: 12/07/2018
Earliest Estimated Award Date: 07/01/2019
Earliest Estimated Start Date: 07/01/2019

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), through the Fertility and Infertility Branch, intends to promote a new initiative by publishing a Request for Applications (RFA) to solicit applications for research consortia to conduct large-scale clinical trials to assess diagnostic and therapeutic interventions in infertility and reproductive medicine.   This new program will be administered through a mechanism in which sites are linked by a common clinical trial protocol as consortia that study a distinct scientific issue that impacts fertility and clinical practice in reproductive medicine.   For the purposes of this RFA, responsive applications will be limited to those with a focus on female infertility, male infertility, and specific conditions that affect fertility, such as polycystic ovary syndrome and endometriosis.
 
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. 

The RFA is expected to be published in Summer 2018 with an expected application due date in Fall 2018.
 
A webinar with NICHD staff will be held early/mid-September 2018 to provide prospective applicants the opportunity to receive information and ask questions about the scientific scope of the funding opportunity and technical details for applying.

This Funding Opportunity Announcement (FOA) will utilize the R01 (Clinical Trial Required) activity code. Details of the planned RFA are provided below.

Research Initiative Details

This Notice encourages investigators with expertise and insights into the area of Infertility and Reproductive Medicine to begin to consider applying for this new FOA.


This FOA is intended to support new multi-site clinical research consortia devoted to evaluating safety and efficacy of new medications, treatments and technologies addressing questions in infertility.  The objective of this program is to advance scientific research that facilitates diagnostic and therapeutic solutions to infertility by using common protocols in large scale human trials to obtain answers more rapidly than individual sites acting alone. This program benefits the public: infertile couples, individuals with reproductive diseases and disorders, and their health care providers
 
Consortium applications proposing trials that advance the personalization of reproductive health care to include collection of clinical and biological variables (e.g., blood for genetic analysis, other potential biomarkers) that might be used to inform or test algorithms to foster personalized treatment strategies; address medical management of mild male factor infertility/subfertility; investigate immunologic aspects of infertility; and evaluate cost-effective alternatives to current diagnostic methods and interventions for evaluation and management of infertility will be strongly encouraged.
 
This FOA will support trials that require participation of two or more collaborative sites for completion of the study.  Accordingly, the collaborating sites share a common protocol across the sites and are organized to increase sample size, accelerate recruitment, and increase sample diversity and representation.  Each site has its own Program Director/Principle Investigator (PD/PI) and is expected to contribute to recruitment.  Each consortium should include a mechanism for coordination, implementation and monitoring of the protocol across sites, quality control, database management, statistical analysis, and reporting. 

Funding Information

Estimated Total Funding The estimated total funding is $4.1 million for fiscal year 2019 pending the availability of funds.
Expected Number of Awards NICHD intends to fund up to three consortia.
Estimated Award Ceiling Consortium total costs should not exceed $2M in year 1 and $3M in out-years. Sites can request up to $700K direct costs.
Primary CFDA Numbers 93.865

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
City or township governments
Special district governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Louis V. DePaolo, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
301-435-6970
Email: ld38p@nih.gov