Notice Number: NOT-HL-16-451

Key Dates
Release Date: September 30, 2016
Response Date: "New Date- December 31, 2016" as per issuance of NOT-HL-16-478 (old response date:December 5, 2016)

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

Purpose

The National Heart, Lung, and Blood Institute (NHLBI) seeks public input on opportunities and strategies to maximize scientific output of clinical research through support of ancillary studies to clinical trials or observational studies. NHLBI invites comments from researchers and others with an interest in clinical research within the mission of the NHLBI.

Background

The mission of the NHLBI is to provide global leadership for research, training, and education programs to promote the prevention and treatment of heart, lung, and blood diseases and sleep disorders, and enhance health, longevity, and quality of life. Multi-center clinical trials and observational studies represent a substantial financial commitment to establish infrastructure for participant recruitment and evaluation. These studies are unique sources of well-characterized patient populations but they are not usually structured to permit a detailed investigation of underlying mechanisms of the disease and its progression; and/or potential biomarkers for monitoring disease progression, optimizing treatment, and predicting patient outcomes.

Ancillary studies are studies that collect new information and/or biological samples directly from participants of the ongoing parent study, and must address new research questions. From 2000 until 2014, NHLBI actively solicited applications for ancillary studies in clinical trials through RFA-HL-14-004. After 2014, NHLBI has supported ancillary studies through the R01 parent announcement. As part of its ongoing stewardship, NHLBI seeks input from the clinical research community to explore optimal strategies to support ancillary studies to clinical trials or observational studies.

Information Requested

This RFI is intended to solicit perspectives and comments about scientific opportunities, critical needs and optimal strategies for supporting clinical ancillary studies. Comments can include but are not limited to the following topics:

• Scientific opportunities that can be realized or have been accomplished through conducting ancillary studies.
  
• Critical challenges that have hindered and will continue to hinder the development of a successful ancillary study proposal.
  
• Strategies to overcome the critical challenges.
  
• Strategies for increasing the number of successful ancillary study applications from junior investigators

Submitting a Response

All responses to this RFI must be submitted via email to Ancillary_Study@mail.nih.gov by December 5, 2016. Please include the RFI number (NOT-HL-16-451) in the subject line of your response. Response to this RFI is voluntary. Responders are free to address any or all of the questions listed above.

This RFI is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government. The NIH does not intend to make any awards based on responses to this RFI or to otherwise pay for the preparation of any information submitted or for the Government's use of such information.

The NIH will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder's submission. However, responses to the RFI may be reflected in future funding opportunity announcements. The information provided will be analyzed and may appear in reports. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Inquiries

Please direct all inquiries to:

Jue Chen, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0550
Email: jue.chen@nih.gov