NOT-RM-20-001: Notice of Extension and Clarification for RFA-RM-19-013 Multisite Clinical Center Common Fund Acute to Chronic Pain Signatures Program: Acute Peri-operative Pain or Musculoskeletal Trauma (UM1 Clinical Trial Optional)

Notice of Extension and Clarification for RFA-RM-19-013 Multisite Clinical Center Common Fund Acute to Chronic Pain Signatures Program: Acute Peri-operative Pain or Musculoskeletal Trauma (UM1 Clinical Trial Optional)

Notice Number: NOT-RM-20-001

Key Dates
Release Date: October 18, 2019

Related Announcements
RFA-RM-19-013

Issued by
Office of Strategic Coordination (Common Fund)

Purpose

This Notice is to alert potential applicants to a change in the receipt date and to provide a clarification regarding responsiveness of applications submitted for RFA-RM-19-013 Multisite Clinical Center Common Fund Acute to Chronic Pain Signatures Program: Acute Peri-operative Pain or Musculoskeletal Trauma (UM1 Clinical Trial Optional).

Part 1. Overview Information

Key Dates

Currently Reads:

Open Date (Earliest Submission Date)

October 25, 2019

Application Due Date(s)

November 26, 2019. All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date

Expiration Date

November 27, 2019

Modified to Read:

Open Date (Earliest Submission Date)

November 26, 2019

Application Due Date(s)

December 27, 2019. All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date

December 28, 2019

Part 2. Full Text of Announcement

Current text:

Key activities of the MCC will be to:

perform study-determined brain imaging and sensory tests at T=0, 3 months and 6 months.

collect bio-specimens for study-determined assays at T = 0, 3 months and 6 months.

Applicants should plan to develop a study enrolling approximately 1800 patients over a two-year period from a SINGLE specific type of surgery OR a SINGLE specific type of musculoskeletal trauma (e.g. thoracotomy or other surgical procedure with expected 30% to 60% rate of transition from acute to chronic pain, or a bone fracture event with expected 30% to 60% rate of transition from acute to chronic pain) and retain these patients for assessments at time = 0, 3 months, and 6 months post-surgery. In other words, all 1800 patients in the study must have experienced the same surgery or musculoskeletal trauma.

Revised Text:

Although three time points are still required, these need not be at T=0, 3 months and 6 months, since time points for the collection of study data elements may be unique to the cohort proposed. Applicants ideally should propose a study design with three time points for collection of all study data elements (including brain imaging, sensory testing, and biospecimen collection) for their entire cohort of 1800 participants. However, applicants may propose to perform selected assays on only a subset of the cohort, if scientifically justified. The proposed time points as well as frequency of data collection for specific phenotypic measures must be clearly articulated in the grant application with supporting scientific justification and power calculations.

All other aspects of this FOA remain the same.

Inquiries

Please direct all inquiries to:

Linda Porter, Ph.D.
National Institute on Neurological Disorders and Stroke (NINDS)
Telephone: 301-435-7572
Email: porterl@ninds.nih.gov