Notice Number: NOT-RM-19-005

Key Dates
Release Date: March 26, 2019
Response Date: June 01, 2019

Issued by
Office of Strategic Coordination (Common Fund)

Purpose

Background

The NIH Common Fund Acute to Chronic Pain Signature (A2CPS) program will use advances in imaging, high-throughput biomedical experiments (‘omics), sensory testing, and psychosocial assessments to explore a range of characteristics from patients who transition or are resilient to developing chronic pain. The studies will collect characteristics of patients from the time of an acute pain event over a period of six months as they recover or develop chronic pain. The key deliverable of the program is a comprehensive data set of objective measures which could be combined to provide “signatures” predictive of transition and resilience to chronic pain.

The A2CPS Program will explore a set of objective biomarkers that in combination can provide a “signature” to predict transition from acute to chronic pain and a signature to predict resilience to chronic pain. The ultimate goals of the program are to accelerate therapy development through identification of predictive biomarkers and to guide chronic pain preventive strategies. These biomarkers are needed urgently to better treat the significant number of people who transition from acute to chronic pain after an acute pain event. The final candidate biomarkers for the program will be determined by A2CPS awardees, NIH staff, and external experts during the planning year of the program, based on information from the literature, preliminary data from the awardees, input from experts, and feedback from the scientific community through this RFI.

This Request for Information (RFI) seeks to obtain suggestions for specific biomarkers that could be included in the A2CPS Program.

Information Requested

NIH seeks input from the scientific community on specific candidate molecules, tests, patient reported outcomes, psychosocial factors, health record data, and/or other characteristics that could potentially serve as high value biomarkers for predicting acute to chronic pain transition and/or resilience which should be considered for inclusion as outcome measures to collect in the studies. All recommendations should be backed up with a rationale and citations from peer reviewed literature or other justification. Potential candidates could include, but are not limited to, the following:

• Specific electronic health record information, including co-occurring conditions, prescription information, etc.
• Specific patient reported outcomes (e.g., PROMIS measures)
• Candidate psychosocial factors
• CNS or other imaging features
• Sensory tests for mechanical, temperature, or other types of pain
• Actinography for sleep and circadian rhythms and locomotor activity
• Molecules that can be obtained in patient blood, serum, or other non-invasively collected fluids
• Candidate genetic variants
  

How to Submit a Response

• Responses to this RFI will be accepted through June 1, 2019. All comments will be anonymous and must be submitted via email to[email protected].
  In your email, please include your candidate biomarker, the biomarker source, and justification with citation for your suggestion. Please note that we are interested in candidate biomarkers that could predict the transition from acute to chronic pain, rather than biomarkers of established chronic pain only.
  Responses to this RFI are voluntary.The Government is under no obligation to acknowledge receipt of the information provided and respondents will not receive individualized feedback.This RFI is for planning purposes only and should not be construed as a solicitation or as an obligation on the part of the United States Government.NIH will use the information submitted in response to this RFI at its discretion. NIH does not intend to make any type of award based on responses to this RFI or to pay for either the preparation of information submitted or the United States Government's use of such information.
  The information submitted will be analyzed and may be shared internally, appear in reports or be reflected in future solicitations, as appropriate and at the Government's discretion.Proprietary, classified, confidential, or sensitive information should not be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s) or other activities.No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Government's use of such information.

Inquiries

Please direct all inquiries to:

[email protected]