Clarification of NHLBI Policy Regarding Submission of Phase II and Beyond Clinical Trials Applications

Notice Number: NOT-HL-17-519

Key Dates
Release Date: June 14, 2017

Related Announcements
PA-16-160
PAR-16-300
PAR-16-301
PAR-16-405
NOT-HL-16-321
NOT-HL-17-518

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

Purpose

This Notice is to clarify the NHLBI policy regarding the submission of applications that have a phase II and beyond clinical trial as the central purpose (see the NIH definition of a clinical trial):

  • NHLBI will not accept phase II and beyond clinical trial applications submitted in response to the NIH Parent R01 (PA-16-160) and its reissuances.
  • NHLBI will continue to accept phase II and beyond clinical trial applications in response to other FOAs – published by NHLBI or FOAs where NHLBI is listed as a participant – that allow such clinical trials.

NOTE: NHLBI will continue to accept early phase clinical trial applications with a primary intent of exploring hypotheses related to biologic and pathobiologic mechanisms of health and/or disease submitted to the NIH Parent R01 (PA-16-160).

Investigators are encouraged to submit an application to NHLBI FOAs purposely designed for phase II and beyond clinical trials:

NHLBI Multi-Site Phase II and Beyond Clinical Trials

An investigator submitting a Phase II and beyond clinical trial proposing to include more than one site for the purposes of recruitment should apply under two specific FOAs or their reissuances:

  • PAR-16-300 Clinical Coordinating Center (CCC) for Multi-Site Clinical Trials (Collaborative UG3/UH3)
  • PAR-16-301 Data Coordinating Center (DCC) for Multi-Site Clinical Trials (Collaborative U24)

NHLBI Single-Site Phase II and Beyond Clinical Trials

An investigator submitting a Phase II and beyond clinical trial using a single site for the purposes of recruitment should apply to PAR-16-405.

Note that PAR-16-300/PAR-16-301 and PAR-16-405 are meant for applications with the primary intent of conducting clinical trial(s) for testing the efficacy, safety, clinical management, or implementation of intervention(s).

Frequently Asked Questions (FAQs) are available at these sites:

FAQs - NHLBI Multi-Site Clinical Trials
https://www.nhlbi.nih.gov/research/funding/new-foas-investigator-initiated-phase-ii-and-above-multi-site-clinical-trials-par-16-300-and-par-16

FAQs - NHLBI Single-Site Clinical Trials
https://www.nhlbi.nih.gov/research/funding/new-foa-investigator-initiated-phase-ii-and-beyond-single-site-clinical-trials-par-16-405-frequently.

Information on NHLBI Research Support Mechanisms for Clinical Trials is available at:
NHLBI Research Support Mechanisms Guidelines and Descriptions. Investigators are strongly encouraged to consult with NHLBI scientific staff for further guidance prior to submitting an application for a clinical trial to determine which FOA will best support the proposed research. 

Inquiries

Please direct all inquiries to:

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0270
Email: NHLBIChiefReviewBranch@nhlbi.nih.gov