DoD Traumatic Brain Injury and Psychological Health, Clinical Trial Award

Description

The intent of the FY23 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 both.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 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. For more information, see the Human Subject Resource Document. Principal Investigators (PIs) proposing comparative effectiveness, implementation science, health care services research as the primary research objective should consider the FY23 TBIPHRP Health Services Research Award (Funding Opportunity Number HT9425-23-TBIPHRP-HSRA). PIs seeking funding for a preclinical research project should consider one of the other FY23 TBIPHRP program announcements or the FY23 Focused Program Award BAA being offered.Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.For the purposes of this funding opportunity Regulatory Agency refers to the FDA or any relevant international regulatory agency unless otherwise noted.Key aspects of the FY23 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 proposal/application must include Community-Based Participatory Research (CBPR) approaches in the development and execution of the clinical trial. CBPR approaches should be documented in Attachments 12 and 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 proposal/application 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 proposal/application 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 proposal/application 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 proposal/application should show strong institutional support and, if applicable, a commitment to serve as the regulatory sponsor, ensuring all sponsor responsibilities described in the Code of Federal Regulations, Title 21, Part 312 (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 bio-equivalence, 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 proposal/application 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.If the proposed clinical trial involves the use of drug that has not been approved by a Regulatory Agency for the proposed investigational use, then an Investigational New Drug (IND) application to the FDA that meets all requirements under 21 CFR 312 or international equivalent application may be required.• It is the responsibility of the applicant to provide evidence from the IRB of record or Regulatory Agency if an investigational drug (e.g., IND) application is not required. If an investigational drug application is required, evidence that an application (e.g., IND) has been submitted, cleared, or authorized without clinical hold status must be included in the TBIPHRP CTA proposal/application.• The investigational drug application should be specific for the product (i.e., the product should not represent a derivative or alternate version of the investigational agent described in the investigational drug application) and indication to be tested in the proposed clinical trial.If the proposed clinical trial involves the use of device that has not been approved by a Regulatory Agency for the proposed investigational use, then an Investigational Device Exemption (IDE) application to the FDA that meets all requirements under 21 CFR 812 or international equivalent may be required.• It is the responsibility of the applicant to provide evidence if an investigational device (e.g., IDE) application is not required or the device qualifies for an abbreviated IDE or (equivalent international application). If an investigational device application is required, evidence that an application (e.g., IDE) has been submitted, cleared, or authorized without clinical hold status has been secured must be included in the FY23 TBIPHRP CTA proposal/application.• The application should be specific for the device (i.e., should not represent a derivative or modified version of the device described in the investigational device application) and indication to be tested in the proposed clinical trial.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 submitted or approved must be included in the FY23 TBIPHRP CTA proposal/ application within Attachment 8, Regulatory Strategy.Funded clinical trials are required to post a copy of the informed consent form used to enroll subjects on a publicly available federal website in accordance with federal requirements described in 32 CFR 219. Funded trials are required to register the study in the National Institutes of Health (NIH) clinical trials registry, www.clinicaltrials.gov, prior to initiation of the study. Refer to the General Submission Instructions, Appendix 1, Section B, for further details.Research Scope: 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. This BAA may not be used to support studies requiring an exception from informed consent (EFIC). Selection of the appropriate FY23 TBIPHRP CTA Research Level is the responsibility of the applicant:• 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 proposal/application’s direct costs budgeted for the entire period of performance should not exceed $500,000.○ Early-Career Investigator Partnering Option: The FY23 TBIPHRP encourages proposals/applications that include meaningful and productive collaborations between investigators. The FY23 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

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