Notice Number: NOT-HL-16-300

Key Dates
Release Date: February 17, 2016
Estimated Publication Date of Announcement: Spring 2016
First Estimated Application Due Date: Fall 2016
Earliest Estimated Award Date: Summer 2017
Earliest Estimated Start Date: Summer 2017

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

Purpose

The National Heart, Lung, and Blood Institute intends to develop a new clinical trials network by publishing a Funding Opportunity Announcement (FOA) to solicit applications for precision, adaptive clinical trial designs to evaluate treatments for severe and/or exacerbation prone asthma.

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 Spring 2016 with an expected application due date in Fall 2016.

This FOA will utilize the U10 activity code. Details of the planned FOA are provided below. Two FOAs for this program will be published (see NOT-HL-16-305).

Research Initiative Details

The goal of the intended FOA will be to develop a clinical network adept at sequential, adaptive clinical trial designs to evaluate the efficacy of interventions in well-phenotyped patients with severe and/or exacerbation-prone asthma. The approach will stratify patients based on phenotype, and use predictive, adaptive designs and intermediate analysis with statistical modeling to determine probability of therapeutic responsiveness. Applicants will propose treatment algorithms that include multiple interventions for the management of severe and/or exacerbation prone asthma, with companion diagnostics to allow for early assessment of therapeutic responsiveness that will guide "go/no-go" decisions for individual patients with regard to specific interventions. Each application must include evaluation of at least one novel intervention that has not previously been used for the treatment of severe and/or exacerbation prone asthma. The final protocol will be decided upon by the PrecISE Steering Committee.

Investigators are encouraged to assemble strong teams with expertise in recruitment and retention of severe and/or exacerbation-prone asthma patients, the conduct of adaptive clinical trials, the identification and validation of prognostic and predictive biomarkers and/or profiles, pathobiology of severe asthma, statistical modeling, and expertise to support central processing of biologic samples, as needed.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Patricia Noel, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0202
Email: noelp@nih.gov