Frequently Asked Questions for the RFA-HL-10-003: Phase II Clinical Trials of Novel Therapies for Lung Diseases (U01)
Q:
Must my application include a proposal for an ancillary study or can
the application include a clinical trial only?
A: No. Each application must include at least one ancillary
study proposal along with the clinical trial.
Q: Do I need a separate budget for the ancillary
study(s)?
A: Yes. Each ancillary study must have a separate
budget. If one ancillary study is proposed, it cannot exceed $150,000
in direct costs. If multiple ancillary studies are proposed the budget
for all of them together may not exceed $250,000 in direct costs.
Q: What are the page limitations for the research
plans?
A: The clinical trial research plan can be
up to 15 pages and the ancillary study(s) can be up to 5. The research
plan should begin with a one page summary of the program, the relationship
between the clinical study and the ancillary study, and the potential
of the intervention to change practice.
Q: Would a high score on my ancillary study interfere
with my chances for funding?
A: No. The clinical study and the ancillary study(s)
will receive separate scores. A highly meritorious clinical study might
be funded on its own. Conversely, an ancillary study will NOT be funded
by itself with out a clinical study.
Q: Ability to recruit is usually a challenge in clinical trials and an important review criterion. How will this be evaluated?
A: The RFA recommends inclusion of at least one subcontract to assure adequate recruitment. Recruitment in previous trials involving a similar patient population should be documented and a statement about the willingness and ability to recruit should be provided from each site. If the applicant or subcontractor is from an institution that is participating in a Network or other major trial, details should be provided as to how the patient population in the proposal is different or how sufficient patients will be obtained. The peer reviewers will evaluate these details and there will be an administrative review by NHLBI staff.
Project Officer:
Andrea Harabin , Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Bethesda, MD 20892-7952
Telephone: (301) 435-0222
Email: harabina@nhlbi.nih.gov
Last updated: March 18, 2009
