Notice of Intent to Publish a Funding Opportunity Announcement for Catalyzing Innovation in Late Phase Clinical Trial Design and Statistical Analysis Plans (X01)

Notice Number: NOT-HL-16-474

Key Dates
Release Date:  December 5, 2016

Estimated Publication Date of Announcement: July 2017
First Estimated Application Due Date: October 2017
Earliest Estimated Award Date: July 2018
Earliest Estimated Start Date: August 2018

Related Announcements

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


The National Heart, Lung and Blood Institute intends to promote a new initiative to catalyze methodological innovation in clinical trial design and analysis by publishing a Funding Opportunity Announcement (FOA). This FOA proposes to support trial design and analysis planning activities for late phase clinical trials (Phase II and beyond) by providing eligible investigators with timely access to a consultative clinical trial methodology resource.

It is anticipated that access to this FOA will provide the clinical trial planning assistance required by an NHLBI investigator to develop a competitive application, including a final protocol synopsis, through either the single-site clinical trial FOA (PAR-16-405) or multi-site (phase II and beyond) clinical trial FOAs (PAR-16-300 Clinical Coordinating Center) and PAR-16-301 (Data Coordinating Center).

This Notice is being provided to allow potential applicants sufficient time to develop responsive proposals. 

The FOA is expected to be published in July 2017 with anticipated application due dates in October 2017 and January 2018.

This FOA will utilize the X01 activity code. Details of the planned FOA are provided below.

Research Initiative Details

Eligible investigators will propose to conduct important clinical or implementation trials that require i) non-standard rather than traditional designs because randomized controlled approaches to the study questions are inadequate, limited, or suboptimal; and ii) the incorporation of novel /innovative statistical analysis techniques.

This initiative encourages trials in areas of heart, lung, blood, and sleep science that include, but are not limited to, studies of rare diseases and/or therapeutics, studies in sub-populations of more common diseases, e.g. precision medicine approaches to common disorders, and late-stage implementation trials.

This Notice encourages clinical investigators at any career stage to apply if they are planning late phase clinical or implementation trials that require specific expertise in alternative designs and innovative statistical analysis plans that may not be available at the investigators’ institutions or within institutional Clinical and Translational Science Award (CTSA) programs.



Please direct all inquiries to:

Division of Blood Diseases and Resources
Andrei Kindzelski, MD, PhD
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-435-0050

Division of Cardiovascular Sciences
Kristin Burns, MD
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-594-6859

Division of Lung Diseases
Lora Reineck, MD, MS
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-435-0222

Center for Translation Research and Implementation Science
Cheryl Boyce, PhD
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-496-1051