Notice Number: NOT-HL-16-314

Key Dates
Release Date: April 5, 2016
Estimated Publication Date of Announcement: Summer 2016
First Estimated Application Due Date: Fall 2016
Earliest Estimated Award Date: July 2017
Earliest Estimated Start Date: September 2017

Related Announcements
RFA-HL-17-019
NOT-HL-16-318 - Notice of Title Change for NOT-HL-16-314

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

Purpose

The National Heart, Lung, and Blood Institute intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for the Data and Coordinating Center (DCC) of the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). The goals of the BMT CTN are to advance hematopoietic cell transplantation (HCT) for all patients, but particularly for patients with rare and difficult to treat blood diseases. This will be accomplished by advancing traditional HCT approaches and by using novel cell and gene therapy approaches.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in July 2016, with an application due date in September 2016.

This FOA will utilize the U24 activity code.

Research Initiative Details

The planned renewal of the BMT CTN will be solicited through two FOAs. The FOA announced by this Notice is for the DCC, while the FOA announced in NOT-HL-16-315 is for the Core Clinical Centers.

The planned FOA for the DCC seeks investigators experienced in clinical trial design, coordination of multicenter clinical trials for hematological diseases, data management, and statistical analyses. Expertise in clinical trials evaluating blood and marrow transplantation, novel cell therapies, and clinical trials conducted under investigational new drug and/or investigational device exemption regulations is required. In addition, partnerships and collaborations with relevant hematology communities, the National Cancer Institute’s National Clinical Trial Network, and relevant pharmaceutical companies are desirable.

The DCC will be expected to facilitate the simultaneous development of multiple protocols, and support all aspects of study coordination, monitoring and data analyses. In addition, the DCC will support training and quality assurance, coordination of the activities of the Data and Safety Monitoring Board and other standing committees, manuscript preparation and data sharing. Funds to support patient care costs and the research protocols will be part of the grant awarded to the DCC; the DCC will be expected to subcontract with transplant centers and laboratories, and distribute funds on a per-patient basis and according to approved protocol budgets. The DCC will be expected to facilitate an Institutional Review Board (IRB) of record or Central IRB for BMT CTN trials.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Nancy DiFronzo, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0080
Email: [email protected]