Prior to Submission of an Application for a Clinical Trial Planning (U34) or Implementation (U01/UM1) Cooperative Agreement

Reviewed October 18, 2011

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is committed to improving the health of patients with rheumatic, musculoskeletal, and skin diseases by supporting investigator-initiated clinical trials that lead to better clinical outcomes. The NIAMSí goal is to identify and fund trials that are as timely and informative as possible, and which will lead to improvements in clinical practices for disease prevention, diagnosis, and treatment. To this end, the NIAMS has enhanced its clinical trials program.

As announced in NOT-AR-11-014, NIAMS will support investigator-initiated, clinical interventional trials through a two part process: (1) a Clinical Trial Planning Grant (U34) followed by (2) a Clinical Trial Implementation Cooperative Agreement (U01 for single site; UM1 for multi-site) to fully implement and conduct the study. Prior consultation with the NIAMS is strongly encouraged for submission of an application for either the NIAMS Clinical Planning Grant (U34) or the NIAMS Clinical Trial Implementation (UM1/U01) Grant, including new and resubmission applications. NIAMS staff will consider whether the proposed clinical trial (implementation or planning stage) meets the goals and mission of the Institute and whether it is appropriate to conduct it as an investigator-initiated clinical trial, but will not evaluate the technical and scientific merit of the proposed trial. Technical and scientific merit will be determined during peer review. In the pre-submission consultation phase, if the proposed trial or planning grant does not meet the goals and mission of the NIAMS, applicants will be so informed. If the NIAMS ascertains that substantial additional planning may be necessary, applicants seeking to submit a UM1/U01 will be encouraged to submit an application to the Clinical Trial Planning Grant (U34) Cooperative Agreement Funding Opportunity Announcement. The NIAMS reserves the right to determine that support for clinical trials may be directed through other available mechanisms supported by the NIAMS.

Investigators who anticipate submission of a Clinical Trial Planning Grant (U34) or Clinical Trial Implementation Grant application (U01/UM1) to the NIAMS should consider the items below in preparation for speaking with an NIAMS Program Officer.

  • Anticipated date of submission.
  • Study title.
  • Study PI(s).
  • Primary institution and potential collaborating sites.
  • Brief description of the objectives of the clinical trial.
  • Brief rationale for the proposed clinical trial:
    • Scientific basis.
    • Clinical significance.
  • Total cost estimate of the clinical trial (not the planning grant), by year.
  • Estimated start date and duration of the clinical trial.

Furthermore, investigators are strongly encouraged to notify the NIAMS prior to submission of the application for either a U34 or a U01/UM1 through a Letter of Intent (LOI). Applicants are encouraged to allow enough time before the planned receipt date to give the Institute at least 10 weeks to discuss the potential application with the investigators, particularly if there has been no prior consultation with the NIAMS about the application. Instructions for preparing the LOI are provided in the Funding Opportunity Announcement. LOI should be submitted to the Scientific /Research contacts listed in the Funding Opportunity Announcement, who will share the request with the appropriate Program Officer.

In addition to technical merit, the NIAMS will consider program priorities in making funding decisions. Those applications that do not meet the criteria outlined above or that are judged to be of low program priority will not receive funding even if found to be scientifically sound in peer review. One benefit of consultation prior to submission of an application is that the Program Officer can discuss with the investigator the extent to which the potential project fits with NIAMS program priorities.