Heads Up: Investigator-Initiated Clinical Trials Opportunities

Heads Up: Investigator-Initiated Clinical Trials Opportunities

If you've been anxiously awaiting the new set of funding opportunity announcements (FOAs) for investigator-initiated clinical trials, NIAID published them on March 22.

We strongly encourage you to request prior consultation with NIAID program staff at least 10 weeks before you apply. There are three scientific/research contacts listed under Agency Contacts, covering the major clinical research areas under this FOA:

• Dr. Ellen Goldmuntz for immunological, allergic, and transplantation-related diseases
• Mr. Martin Gutierrez for AIDS
• Dr. Shy Shorer for non-AIDS infectious diseases

If you plan to apply for the first submission date in June, we recommend calling your appropriate scientific/research contact right away since there aren't 10 weeks left before then.

For R01 and U01 applications with requests of $500,000 or more for direct costs in any year, submit requests for prior approval no later than April 9.

When you discuss your plans with your program officer, he or she can advise you on research risk, appropriate award type, programmatic interest in your idea, and your readiness to implement a trial.

Your application must meet NIAID's expectations for responsiveness so it can proceed to peer review. Carefully review the "Prior Consultation With NIAID" and "Responsiveness Criteria" sections of the FOAs.

Learn more about the prior consultation process and other aspects of the new opportunities in our updated Investigator-Initiated Clinical Trial Resources and the Guide notices for the opportunities:

• NIAID Clinical Trial Planning Grant (R34)
• NIAID Clinical Trial Implementation Grant (R01)
• NIAID Clinical Trial Implementation Cooperative Agreement (U01)

We'll publish any follow-up guidance or advice in a future issue of this newsletter.