Last month, NIAID reissued the notice of funding opportunity (NOFO) NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed). It’s one of several NOFOs within our suite of opportunities designed to support Investigator-Initiated Clinical Trials.
The clinical trial planning grant (R34) provides up to $150,000 in direct costs for a 1-year project period, during which you can complete planning, design, and preparation of the documentation necessary to implement an investigator-initiated clinical trial (IICT). Ideally, by the end of the project period, you will have a complete study protocol and associated documents, including a manual of operations.
Plus, as a secondary benefit, your R34 application will permit early peer review of the rationale for your proposed clinical trial, as well as an assessment of the design and protocol of the trial in a preliminary form.
What’s Allowed
The list of permissible activities under an R34 is extensive. You can:
- Establish a research team.
- Identify collaborators and enrollment sites.
- Design the study.
- Develop milestones.
- Develop the complete clinical protocol.
- Develop plans for data and safety monitoring, statistical analysis, data management, and data sharing.
- Create the informed consent and assent form, if applicable.
- Develop the investigator's brochure and manual of operations.
- Write a description of recruitment strategies.
- Develop a plan to acquire and administer study agents.
- Obtain Office of Human Research Protections assurances.
- Prepare agreements and arrangements.
- Determine whether the trial will be conducted under an investigational new drug or investigational new device exemption and who will hold it.
- Prepare the package to submit to regulatory authorities.
- Develop a detailed budget for the clinical trial including preparation of a final study report.
- Develop and test procedures for biospecimen collection, storage, and shipping.
- Develop training materials and training plans for study staff.
Conversely, there are a few things you must not propose in your R34 application:
- Clinical trial planning activities for more than one trial.
- Collection of clinical or preclinical data as a part of the future trial.
- Any investigational product development activities.
- Implementation of a clinical trial.
In addition to the NOFO itself, linked above, we recommend you review our Investigator-Initiated Clinical Trial R34 Planning Grants Questions and Answers.
Applications are next due on September 13, 2023. Thereafter, the NOFO offers three annual receipt dates.
Talk to Us!
Clinical trials are expensive and time-consuming. In addition to significant oversight, they require extensive infrastructure. You should scrutinize the viability of your intended project as early as possible.
For that reason, we strongly suggest you contact NIAID for a prior consultation at the outset of pursuing IICT funding. Our staff can:
- Verify that your proposed clinical trial meets NIAID’s goals, fits within our mission, and addresses a high-priority research area.
- Determine the risk level of your proposed trial.
- Explain the documentation ultimately required to submit an IICT application.
- Identify other mechanisms to possibly support your clinical trial, e.g., a different NOFO or one of our clinical trial networks.
Read Requesting Prior Consultation—Clinical Trial Applications and Planning Grants and then contact:
- Dr. Ellen Goldmuntz, Division of Allergy, Immunology, and Transplantation, at egoldmuntz@niaid.nih.gov or 240-627-3502
- Martin Gutierrez, Division of AIDS, at mgutierrez@niaid.nih.gov or 240-292-4844
- IICT Central Contact Mailbox, Division of Microbiology and Infectious Diseases, at NIAID_DMID_IICT@niaid.nih.gov