NOT-HL-16-303: Notice of Intent to Publish a Funding Opportunity Announcement for Investigator-Initiated Multi-Site Clinical Trials: Clinical Coordinating Center (UG3/UH3)

Notice of Intent to Publish a Funding Opportunity Announcement for Investigator-Initiated Multi-Site Clinical Trials: Clinical Coordinating Center (UG3/UH3)

Notice Number: NOT-HL-16-303

Key Dates
Release Date: February 22, 2016
Estimated Publication Date of Announcement: April 2016
First Estimated Application Due Date: October 2016
Earliest Estimated Award Date: Summer 2017
Earliest Estimated Start Date: Summer 2017

Related Announcements
PAR-16-300
PAR-13-128
NOT-HL-16-297
NOT-HL-16-304

Issued by
National Heart, Lung, and Blood Institute (NHLBI)

Purpose

A number of NHLBI’s large, multi-site trials are solicited through PAR-13-128 Investigator-Initiated Multi-Site Clinical Trials (Collaborative R01). The upcoming expiration of PAR-13-128 presents an opportunity for NHLBI to implement new approaches to enhance the likelihood of clinical trial success and continue to support high-impact clinical trials that shape medical practice and lead to improved health.

The purpose of this Notice is to inform potential applicants that the NHLBI intends to publish a Funding Opportunity Announcement (FOA) that will support investigator-initiated multi-site clinical trials (Phase II and above) through a new bi-phasic, milestone-driven cooperative agreement (UG3/UH3) award. A companion FOA is expected to be published in parallel for collaborative Investigator-Initiated Multi-site Clinical Trials: Data Coordinating Center (U24) applications (see NOT-HL-16-304).

The FOA is expected to be published in Spring 2016 with an expected application due date in Fall 2016.

Research Initiative Details

Details regarding the Clinical Coordinating Center FOA are being provided below to allow potential applicants sufficient time to develop responsive projects and meaningful collaborations and to begin to consider the requirements that are part of the new milestone-driven UG3/UH3 phased award.

The key aspects of this new approach are to:

Establish expectations by setting milestones and timelines that will facilitate successful completion of clinical trials. Milestones will be identified by applicants and used to generate a set of shared expectations regarding trial performance and results dissemination.
Support two phases of study: a study start-up phase of up to one year (UG3 phase of the award) and a full enrollment and study execution phase (UH3 phase of the award). The NHLBI will conduct administrative reviews between the two phases that will examine progress toward meeting study milestones.
Provide project support for five years with the potential for up to seven years if strongly justified.
Implement a project management plan to proactively monitor operational risks, evaluate potential barriers to scientific activities, and propose solutions as needed. This will facilitate earlier identification of challenges experienced by clinical trials and enable investigators and NHLBI staff to propose contingency plans and solutions.
Facilitate peer review of both scientific impact and operational feasibility of proposed multi-site clinical trials.

The NHLBI encourages applicants to consider the following requirements of the new Multi-site Clinical Trials FOA:

NHLBI will not accept a Clinical Coordinating Center (UG3/UH3) application without the submission of the collaborating Data Coordinating Center (U24) application.
PD(s)/PI(s) for the Clinical Coordinating Center (UG3/UH3) cannot be PD(s)/PI(s) on the Data Coordinating Center (U24) award.

The Clinical Coordinating Center application should include the following elements:

The proposed research must address a scientifically important question and must have public health or clinical applicability.
Demonstration of operational feasibility including supporting data and processes for reaching key milestones within indicated timelines.
Identification of key milestones that will serve as the basis of a set of shared expectations regarding trial performance and results dissemination.
Timelines and processes for reaching key milestones, including accrual targets.
Project management plan outlining strategies to proactively monitor operational risks, evaluate potential barriers to scientific activities, and propose solutions and contingency plans ensuring the project is optimally implemented and managed.
Clinical protocol synopsis.
Detailed information on the expertise of the proposed team in clinical trial conduct.
For trials using an FDA regulated product and requiring an IND or IDE application, the grant application must include evidence regarding the outcome of a pre-IND or pre-IDE meeting, or other evidence of communication with FDA. The IND application or IDE application must be submitted to the FDA at least a month prior to a potential award so that documentation of the FDA determination regarding the application is available to NHLBI prior to a possible award.

NHLBI Program Staff will conduct a webinar in Spring/Summer of 2016 to answer questions from potential applicants about the new FOA and submission process.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Keary A. Cope, PhD
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-435-0287
Email: NHLBIClinicalTrials@mail.nih.gov