DoD Traumatic Brain Injury and Psychological Health, Clinical Trial Award

Description

The intent of the FY21 TBIPHRP CTA is to support the rapid implementation of clinical trials with the potential to have a significant impact on TBI and/or psychological health through clinical applications, including healthcare products, technologies, and/or practice guidelines.Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, therapies, clinical guidance, emerging approaches and technologies, and/or new indications for products currently FDA-approved or -cleared. Clinical trials may also be designed to evaluate novel methods for improving dissemination and implementation or investigate the mechanisms of action of new interventions.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. Proposals/Applications proposing clinical care translation research as the primary research objective (e.g., comparative effectiveness, implementation science, healthcare services research) are not permitted under this mechanism and should consider the FY21 TBIPHRP Translational Research Award (Funding Opportunity Number: W81XWH-21-TBIPHRP-TRA).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 placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. Funded trials are required to post a copy of the Institutional Review Board (IRB)-approved informed consent form used to enroll subjects on a publicly available federal website in accordance with federal requirements described in Code of Federal Regulations, Title 32, Part 219 (32 CFR 219). For more information, a Human Subject Resource Document is provided at https://cdmrp.army.mil/pubs/pdf/Human%20Subjects%20Resource%20Document.pdfClinical research is defined as: (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies; (2) epidemiologic and behavioral studies; and (3) outcomes research and health services research. Note: Studies that meet the requirements for IRB review Exemption 4 are not considered CDMRP-defined clinical research. IRB Exemption 4 refers to research involving the collection or study of existing de-identified specimens or data, if these sources are publicly available. Studies seeking to conduct clinical research only but not a clinical trial do not meet the intent of the award mechanism and will not be funded.This BAA may not be used to support studies requiring an exception from informed consent (EFIC).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.Selection of the appropriate FY21 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 period of performance of Research Level 1 awards will be 3 years. The anticipated total costs budgeted for an FY21 TBIPHRP CTA Research Level 1 award will not exceed $750,000.○ Early-Career Investigator Partnering Option: The FY21 TBIPHRP encourages proposals/applications that include meaningful and productive collaborations between investigators. The FY21 TBIPHRP CTA (Research Level 1 only) includes an option for an Early-Career Investigator Partnering. The Principal Investigators (PIs) may have experience in similar or disparate scientific disciplines, but each PI is expected to bring distinct contributions to the proposal/application. The Early-Career Investigator Partnering Option is structured to accommodate two PIs. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with proposal/application submission. The other investigator will be the Partnering PI. Either the Initiating or Partnering PI may be the Early-Career Investigator. Both PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work (SOW), and other required components. The proposal/application is expected to describe how the PIs’ unique experience/expertise combined as a partnership will better address the research question, how the unique experience/expertise that each individual brings to the proposal/application is critical for the research strategy and completion of the SOW, and why the work should be done together rather than through separate efforts. If recommended for funding, each PI will be named to an individual award within the recipient organization. For individual Department of Defense (DOD) FY21 TBIPHRP submission requirements for the Initiating and Partnering PI, refer to Section II.D.2, Content and Form of the Proposal/Application Submission. Research Level 2: Research Level 2 is intended to support phase 1 and more advanced clinical trials for promising treatments or interventions. The period of performance of Research Level 2 awards will be 4 years. The anticipated total costs budgeted for an FY21 TBIPHRP CTA Research Level 2 award will not exceed $3M. Research Level 3: Research Level 3 is intended to support larger-scale clinical trials that demonstrate efficacy in relevant patient populations. The period of performance of Research Level 3 awards will be 4 years. The anticipated total costs budgeted for an FY21 TBIPHRP CTA Research Level 3 award will not exceed $6M.Funding from this award mechanism must support a clinical trial and cannot be used for animal studies. PIs seeking funding for a preclinical research project or a clinical research project that does not involve a clinical trial should consider one of the other applicable FY21 TBIPHRP program announcements or BAA being offered.If the proposed clinical trial involves the use of a drug that has not been approved by the FDA for the proposed investigational use, then an Investigational New Drug (IND) application to the FDA 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 FDA if an IND is not required. If an IND is required, an IND without a partial or complete clinical hold status must be obtained by the FY21 TBIPHRP CTA proposal/application submission deadline. The IND 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 IND application) and indication to be tested in the proposed clinical trial. For more information on IND applications, the FDA has provided guidance at https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsare developedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm.If the investigational product is a device, then an Investigational Device Exemption (IDE) application to the FDA that meets all requirements under 21 CFR 812 may be required. It is the responsibility of the applicant to provide evidence from the IRB of record or the FDA if an IDE is not required or if the device qualifies for an abbreviated IDE. If an IDE is required, an IDE without a partial or complete clinical hold status must be obtained by the FY21 TBIPHRP CTA proposal/application submission deadline. The IDE should be specific for the device (i.e., should not represent a derivative or modified version of the device described in the IDE 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 by the FY21 TBIPHRP CTA proposal/application submission deadline is required.The following are important aspects of the FY21 TBIPHRP CTA: The proposed clinical trial is expected to begin no later than 6 months after the award date, or 9 months after the award date for FDA-regulated studies. The proposed intervention(s) to be tested should offer significant potential impact for individuals affected by TBI and/or psychological health conditions. Inclusion of preliminary data relevant to the proposed clinical trial is required. The proposed clinical trial must be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the relevant literature. The proposal/application should include community-based organization(s)/members in the development and execution of the clinical trial. The proposal/application should describe the planned indication for the product label, if appropriate, and include an outline of the product development plan required to support that indication. The proposal/application should demonstrate availability of, and access to, a suitable patient population that will support a meaningful outcome for the study. The proposal/application should include a discussion of how accrual goals will be achieved and how standards of care may impact the study population. The proposal

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