This Funding Opportunity Announcement (FOA) will support planning grants for investigator-initiated clinical interventional trials. The R34 planning grant is designed to enable the necessary planning, design, and preparation of documentation prior to implementation of investigator-initiated clinical trials.
Donor Name: National Institutes of Health
State: All States
County: All Counties
Territory: Commonwealth of Puerto Rico, U.S. Virgin Islands, Guam, American Samoa, Commonwealth of the Northern Mariana Islands
Type of Grant: Grant
Deadline: 11/03/2023
Grant Duration: 2 years
Details:
The NIAMS is committed to identifying effective approaches to address arthritis and musculoskeletal and skin diseases and disorders. Improving health through the generation of high-quality data from well-designed and executed clinical research is a high priority for the NIAMS. To meet this priority, NIAMS developed a Clinical Research Funding Program to support a spectrum of studies spanning from early clinical research development to implementation of clinical trials with four FOAs tailored to meet different needs. The four FOAs are:
- Clinical Observational Studies (R01) to support observational studies (studies that do not involve an intervention) that could inform future clinical trials or clinical research
- Exploratory Clinical Trials (R21) to support small, early-stage clinical trials
- Clinical Trial Planning Grants (R34 – this FOA) to support planning for complex and/or large future clinical trials
- Clinical Trial Implementation Cooperative Agreements (U01) to support the conduct of clinical trials
Scope of the R34 Planning Grant
The range of activities proposed in the R34 planning grant will depend on state of development of the trial as well as the type and complexity of the trial being planned. As described above, the collection or evaluation of pre-clinical or clinical data is not allowed under this R34. Only model recruitment, which is testing the feasibility of recruitment strategies with human subjects to further refine or adjust recruitment methods is acceptable. Activities supported by the R34 planning grant include, but are not limited to, the following examples:
- Develop a clinical study protocol adhering to International Conference on Harmonisation (ICH) E6 Good Clinical Practice Consolidated Guidance
- Develop a manual of operating procedures (MOP) using the NIAMS guidelines which include a detailed description of study procedures and process details, validation, and quality control for any non-standard clinical or laboratory/mechanistic testing which will be performed in the trial
- Develop a preliminary data and safety monitoring plan (DSMP) using the NIAMS guidelines to address how risk to subjects in the clinical trial will be minimized and the process for collecting and reporting of adverse events to the appropriate regulatory bodies
- Develop intervention documents which may include an investigator’s brochure or an intervention monitoring manual
- Develop a Clinical Monitoring and Data Management Plan
- Initiate the IRB approval process; for a multi-site trial, begin process for single-IRB
- Develop consent form(s) and, if applicable, assent form(s)
- Develop a recruitment and retention plan which incorporates the NIH Inclusion of Women and Minorities as Participants in Clinical Research and the NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan
- Conduct “model recruitment” to test recruitment feasibility
- Develop a statistical analysis plan (SAP)
- Identify collaborators and clinical site(s), which may include negotiating sub-contract
- Develop training materials and training/certification plans for study staff who will carry out the study
- Develop a plan for the acquisition and administration of study agent(s)
- Negotiate agreements with industry or other partners to provide drugs, devices, or other resources for trial implementation
- Develop a complete set of suitable documents for submission to the appropriate regulatory authorities such as the FDA (i.e., Investigational New Drug [IND] application or IND exemption, or Investigational Device Exemption [IDE] application)
- Develop a preliminary timeline and budget for conduct and completion of the future clinical trial including funding for orderly close-out of clinical sites and preparation of a final study report
- Develop a detailed project timeline for submission of the U01 clinical trial.
Grant Period
The maximum project period is two years.
Eligibility Criteria
- Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
- The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
- Local Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- Federal Government
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
- Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations.
For more information, visit Grants.gov.
