DoD Traumatic Brain Injury and Psychological Health, Clinical Trial Award

Description

The intent of the FY24 TBIPHRP CTA is to support the rapid implementation of clinical trials with the potential to have a significant impact on psychological health conditions and/or TBI through clinical applications, including health care products, technologies, and/or practice guidelines. Proposed research can be aligned with TBI, psychological health, or in combination.Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), diagnostics, devices, therapies, clinical guidance, behavioral interventions, emerging approaches and technologies, and/or new indications for products currently U.S. Food and Drug Administration (FDA)-approved or -cleared. Interventions that are not FDA-regulated (or international equivalent) are within scope but the regulatory status must be documented in Attachment 8, Regulatory Strategy. Proposed projects may range from small proof-of-concept trials (e.g., pilot, first-in-human, phase 0) to demonstrate feasibility or inform the design of more advanced trials through large-scale trials to determine efficacy in relevant patient populations.Funding from this award mechanism must support a clinical trial. A clinical trial is defined in the Code of Federal Regulations, Title 45, Part 46.102 (45 CFR 46.102) as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.For more information, a Human Subject Resource Document is provided at https://cdmrp.health.mil/pubs/pdf/Human%20Subjects%20Resource%20Document_DEC2022.pdf.Principal Investigators (PIs) proposing comparative effectiveness, implementation science, health care services research as the primary research objective should consider the FY24 TBIPHRP Health Services Research Award (Funding Opportunity Number HT942524TBIPHRPHSRA). PIs seeking funding for a preclinical research project should consider one of the other FY24 TBPHRP program announcements.Key aspects of the FY24 TBIPHRP CTA:• Clinical Trial Start Date: The proposed clinical trial is expected to begin no later than 6 months after the award date for studies regulated by the Regulatory Agency.• Preliminary data are required: Inclusion of preliminary data relevant to the proposed clinical trial is required.• Community-Based Participatory Research: The application/proposal must include Community-Based Participatory Research (CBPR) approaches in the development and execution of the clinical trial. CBPR approaches should be documented in Attachment 13.• Study Population: The application should demonstrate the availability of and access to a suitable patient population that will support a meaningful outcome for the study. The application should include a discussion of how accrual goals will be achieved, as well as the strategy for inclusion of women and minorities in the clinical trial appropriate to the objectives of the study. Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, gender, ethnicity, or race (typically classified as exempt from Institutional Review Board [IRB] review) are exempt from this requirement.• Intervention Availability: The application/proposal should demonstrate the documented availability of and access to the drug/compound, device, and/or other materials needed, as appropriate, for the proposed duration of the study.• Personnel and Environment: The application/proposal should demonstrate the study team’s expertise and experience in all aspects of conducting clinical trials, including appropriate statistical analysis, knowledge of Regulatory Agency processes (if applicable), and data management. The application/proposal should include a study coordinator(s) who will guide the clinical protocol through the local IRB of record and other federal agency regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate participant accrual. The application/proposal should show strong institutional support and, if applicable, a commitment to serve as the regulatory sponsor, ensuring all sponsor responsibilities described in 21 CFR 312, Subpart D, for FDA-regulated studies.• Innovative Clinical Trial Design: When appropriate, the TBIPHRP encourages the use of innovative clinical trial design approaches (e.g., Bayesian, adaptive, clinical bioequivalence, seamless, exploratory/phase 0, basket, stepped wedge) that improve efficiency and ability to determine clinical benefit while maintaining validity, integrity, and ethical considerations.• Precision Medicine Approaches: When appropriate, the TBIPHRP encourages the use of precision medicine approaches. These tailored treatments deliver the right treatment at the right time while considering an individual’s unique characteristics.• Statistical Analysis and Data Management Plans: The application/proposal should include a clearly articulated statistical analysis plan, a power analysis reflecting sample size projections that will answer the objectives of the study, and a data management plan that includes use of an appropriate database to safeguard and maintain the integrity of the data. If required by a Regulatory Agency, the trial must use a 21 CFR 11-compliant database and appropriate data standards.For the purposes of this funding opportunity Regulatory Agency refers to the FDA or any relevant international regulatory agency unless otherwise noted.If the proposed clinical trial involves the use of a drug that has not been approved by the relevant Regulatory Agency for the country where the research will be conducted, then submission of an Investigational New Drug (IND) application, or equivalent, that meets all requirements under 21 CFR 312 may be required.• It is the responsibility of the applicant to provide evidence from the IRB of record or the relevant Regulatory Agency if an IND, or equivalent, is not required. If an IND, or equivalent, is required, the regulatory application must be approved/cleared/authorized or submitted to the relevant Regulatory Agency within the first 60 days of the award.• The investigational drug application, or equivalent, should be specific for the product and indication to be tested in the proposed clinical trial. For more information on FDA IND applications specifically, the FDA has provided guidance at https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application.If the investigational product is a device, then submission of an Investigational Device Exemption (IDE), or equivalent, application that meets all requirements under 21 CFR 812 may be required.• It is the responsibility of the applicant to provide evidence if an IDE, or equivalent, is not required. If an IDE, or equivalent, is required, the IDE application, or equivalent, must be approved/cleared/authorized or submitted to the relevant Regulatory Agency within the first 60 days of the award. • The investigational device application, or equivalent, should be specific for the device and indication to be tested in the proposed clinical trial. For more information on FDA IDE applications specifically, the FDA has provided guidance athttps://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide.If the proposed clinical trial of an investigational product will be conducted at international sites, evidence that an application to the relevant national regulatory agency of the host country(ies) has been approved/cleared/authorized or submitted within the first 60 days of the award within Attachment 8, Regulatory Strategy.Research Levels: The following are general descriptions, although not all-inclusive, of the scope of research projects that would be appropriate to propose under the current BAA. Only one Research Level category may be chosen per application. It is the responsibility of the applicant to select the level that aligns with the scope of the proposed research. The Research Level should be selected based on the research scope and not on the amount of the budget. Refer to Section II.D.6, Funding Restrictions, for detailed funding information.• Research Level 1: Research Level 1 is intended to support proof-of-principle pilot studies, phase 0/small phase 1 trials, correlative studies related to an intervention, and other innovative, exploratory clinical trials. The maximum period of performance is 3 years. The application/proposal’s direct costs budgeted for the entire period of performance should not exceed $500,000.○ Early-Career Investigator Partnering Option: The FY24 TBIPHRP CTA (Research Level 1 only) includes an Early-Career Investigator Partnering Option that is structured to accommodate two PIs, one of whom is an Early-Career Investigator. The combined direct costs budgeted for the entire period of performance in the proposals/applications of the Initiating PI and Partnering PI should not exceed $500,000.– The PIs may have experience in similar or disparate scientific disciplines, but each PI is expected to bring distinct contributions to the application/proposal. One PI will be identified as the Initiating PI and will be responsible for most of the administrative tasks associated with application/proposal submission. The other investigator will be the Partnering PI. At least one of the Initiating or Partnering PIs must be an Early-Career Investigator.– The intent is not to create mentor-mentee arrangement. Both PIs should contribute significantly to the development of the proposed research project, including the Project Narr

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