Notice Number: NOT-HL-16-304

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-13-128
NOT-HL-16-297
NOT-HL-16-303

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 clinical 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 a Data Coordinating Center for investigator-initiated multi-site clinical trials (Phase II and above) through a milestone-driven cooperative agreement (U24) award. A companion FOA is expected to be published in parallel for collaborative Investigator-Initiated Multi-site Clinical Trials: Clinical Coordinating Center (UG3/UH3) applications (see NOT-HL-16-303).

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 Data Coordinating Center FOA are being provided 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 award.

The key aspects of this new approach include:

• Establish Data Coordinating Center expectations for support of the associated clinical trial by setting milestones and timelines that will facilitate successful completion of the associated clinical trial. Milestones will be identified by applicants and used to generate a set of shared expectations regarding trial performance and results dissemination.
• Due to the collaborative and parallel nature of these FOAs, the Data Coordinating Center will be phased-out after a close-out period if the collaborating Clinical Coordinating Center award ends early.
• Provide project support for five years with the potential for up to seven years if strongly justified.
• Implementation of 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 the multi-site clinical trial.

The NHLBI encourages applicants to consider the following requirements of the new Data Coordinating Center FOA:

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

The Data Coordinating Center application should include the following elements:

• Study organization plan.
• A project management plan outlining strategies to proactively monitor operational risks, evaluate potential barriers to scientific activities, and propose solutions and contingency plans to ensure that the project is optimally implemented and managed.
• Statistical analysis plan.
• Data and Safety Monitoring Plan (DSMP).
• Milestones and metrics to evaluate trial performance and results dissemination.
• Timelines and processes for reaching key milestones, including accrual monitoring.
• Transfer of data to the NHLBI clinical trials database through tools provided by the Institute at the time of 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