Frequently Asked Questions for PAR-10-005 NHLBI Clinical Trial Pilot Studies (R34)
Q: Are first in human studies, early safety studies, phase I studies or other feasibility studies responsive to this Funding Opportunity Announcement (FOA)?
A: Probably not. The intent of this NHLBI R34 FOA is to provide support to collect information needed to finish the design of a clinical trial with public health importance. One of the review considerations is “Ability of the proposed project to effectively address all key issues that currently prohibit completion of the trial design”. In general, first in human studies, early safety studies, studies to define dose-response or other Phase I or I-II type studies will not meet the criterion of both “necessary and sufficient” to design the planned full-scale trial with large public health impact.
Q: How much information should I provide on the planned full-scale trial?
A: The reviewers cannot evaluate a pilot study without understanding the full scale trial’s goals and how the results of the pilot study will inform its design. Specifically, the application should contain enough information for the reviewers to evaluate: 1) the hypothesis of the trial, 2) the public health impact of the trial, 3) whether the planned design of the trial will address the hypothesis, 4) how the information gathered through an R34 grant will contribute to the design of the trial, and 5) whether the information gathered with the R34 is both necessary and sufficient for you to make the final decisions about the trial design.
Q: I have developed a clinical trial and need support to identify clinical sites, finalize the protocol and write the manual of procedures. Is the NHLBI R34 mechanism appropriate?
A: No, it is not. Some R34 FOAs sponsored by other NIH institutes permit this, but the NHLBI PAR-10-005 is specifically tailored to support research addressing gaps in knowledge necessary to complete the design of a trial with large public health impact.
Q: If I am an Early Stage Investigator (ESI) and am awarded an R34, will I lose the ESI status?
A: No, an R34 does not count against the ESI status. However, other factors could. Please see http://www.nhlbi.nih.gov/funding/training/redbook/newinvest.htm
Q: If I qualify as an Early Stage Investigator (ESI), will I be given special funding consideration?
A: No, the R34 is not eligible for ESI special funding consideration.
Q: Can I submit an R34 and an R01 for the same trial simultaneously?
A: This is not advisable. An R01 application for a clinical trial that lacks sufficient information to justify its design would not be competitive and would spend one of your two allowed R01 application submissions for that trial, On the other hand, reviewers are unlikely to look favorably on an R34 application if you already have sufficient information to design a competitive full-scale trial. In this case, you should submit an R01 application directly.
Q: Can I submit two R34s for the same planned follow-up trial?
A: No. If you need two R34s, neither one will meet the criterion of “both necessary and sufficient” to design the follow-up trial.
Q: If I submitted an R01 application for a clinical trial and the reviewers said that I needed more data to justify or show feasibility of one aspect, may I apply for an R34 for that trial?
A: Yes, if the questions you are asking meet the criteria of PAR-10-005, you may apply, even if you have already applied unsuccessfully for an R01 for the same trial. The R34 will be a new application; however, following completion of the R34, the follow-up R01 application will be considered a resubmission (A1). As such, another second revision (i.e., A2) will not be accepted.
Q: If I previously submitted an R01 that was twice reviewed but unfunded -- with part of the criticism being that the study lacks pilot data – can I submit an R34 grant application?
A: No, not for this trial. The NHLBI R34 mechanism is to support acquisition of critical pilot data for clinical trial applications to NIH. Since NIH will no longer accept a third (A2) submission for any application that was not initially submitted before January 25, 2009 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-080.html), a trial has already been reviewed twice will not be eligible for submission and therefore not eligible for an R34.
Q: Is there a standing committee that reviews the applications submitted to PAR-10-005?
A: The Clinical Trials Review Committee (CLTR) is the scientific review group that reviews the R34 applications. The Membership roster for this committee can be found by navigating to http://www.nhlbi.nih.gov/about/advisory.htm#peer
Q: Do I have to submit a Letter of Intent if I am planning to submit an R34 application?
A: Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. Prospective applicants are asked to submit a letter of intent whether it is for a new or resubmission (A1) application. Please refer to section 3.A.1 of PAR-10-005 for the specific information to provide in your letter of intent and where to send it.
Last update: October 27, 2010