Notice Number: NOT-AR-15-019

Key Dates
Release Date: September 2, 2015
Response Date: New Date November 15, 2015 per issuance of NOT-AR-15-020. (Original Response Date: October 15, 2015 )

Issued by
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Purpose

The purpose of this Request for Information (RFI) is to solicit input from the extramural community that will inform the mechanisms and processes the NIAMS uses to support high-impact clinical trials. The NIAMS invites comments from researchers, patient advocacy groups, patients and their healthcare providers.

Background

In 2010, the NIAMS initiated an effort to support investigator-initiated clinical trials through a specific suite of funding opportunity announcements (FOAs). The goal of the NIAMS initiatives for clinical trial planning and execution was to enhance the rigor, timeliness and impact of the trials we support. When the NIAMS developed these clinical trials initiatives, the Institute envisioned a pathway to clinical trial implementation that would facilitate moving important ideas forward and allow some staging with pilot and feasibility grants as well as planning grants available to guide and support the process. Currently, the suite of clinical trials FOAs include the: (1) Exploratory Clinical Trial Grants (R21), (2) Clinical Trial Planning Cooperative Agreement (U34), (3) Clinical Trial Implementation Cooperative Agreement (U01) and Clinical Observational Studies (COS) in Musculoskeletal, Rheumatic and Skin Diseases (R01). The links to the current FOAs and detailed information about the current NIAMS policies related to clinical trials can be found at: http://www.niams.nih.gov/Funding/Clinical_Research/clinical_main.asp

The initial set of funding opportunities, the R21, U34 and U01, were designed to enable early phase pilot and feasibility studies, to provide support and time for administrative planning activities that seemed to be delaying the initiation of patient recruitment, and to support clinical trials through a cooperative agreement mechanism to keep program staff engaged with the facilitation and monitoring of all aspects of the trial itself. The COS R01 was added more recently to provide a distinct opportunity for observational studies that could inform future trials. The NIAMS also formed a dedicated study section for the review of these initiatives to address the concern that clinical trials that had been submitted as investigator-initiated R01s and reviewed in various CSR study sections were not receiving the appropriate scrutiny for significance of the question being asked, potential impact of results, and rigor of the study design.

Since the initial publication of the clinical trials FOAs, several trans-NIH committees have been considering the way clinical trials are supported by each of the Institutes and Centers. The NIAMS has participated in these groups; insights and options from those groups will likely be incorporated into the next phase of our clinical initiatives. In particular, the recent change in the way the NIH defines a clinical trial (NOT-OD-15-015) must be considered as the Institute reissues its suite of clinical trials FOAs.

Information Requested

This RFI is intended to solicit perspectives and comments from the broad community about factors that influence the Institute's success in supporting impactful and meritorious applications for clinical trials. Organizations are strongly encouraged to submit a single response that reflects the views of their organization and membership as a whole. The NIAMS seeks feedback and information relevant to the optimization of the NIAMS support for clinical trials that includes, but is not limited to, the following areas:

• Ways the current NIAMS suite of clinical trials FOAs can be improved to adequately provide opportunities for all types of clinical trials;
• Types of funding support that are necessary for the different stages of clinical trial implementation (from conceptualization to full implementation);
• Ways the NIAMS can optimize the early review of a concept of a future clinical trial and thoughts about any benefits that might result from having the NIAMS conduct a review of a concept of a CT at an early stage;
• Other areas seen as relevant to the optimization of the NIAMS support of clinical trials.

How to Submit a Response

Responses to this RFI can be submitted anonymously. If you choose not to identify yourself when replying, please identify your role in the field to help us better understand the thoughts of particular groups. For example, please indicate if you are a researcher in a NIAMS mission area, a care provider, or a patient advocate.

To ensure consideration, all responses to this RFI will be accepted until October 15, 2015.

Respond by email to NIAMSclinicaltrials@mail.nih.gov.

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 FOAs. 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:

Laura K. Moen, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-451-6515
Email: moenl@mail.nih.gov