OpportunityTitle: 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:&#61623; 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.&#9675; 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&#8217; 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.&#61623; 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.&#61623; 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:&#61623; 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.&#61623; The proposed intervention(s) to be tested should offer significant potential impact for individuals affected by TBI and/or psychological health conditions.&#61623; Inclusion of preliminary data relevant to the proposed clinical trial is required.&#61623; 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.&#61623; The proposal/application should include community-based organization(s)/members in the development and execution of the clinical trial.&#61623; 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.&#61623; 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.&#61623; The proposal/application should demonstrate documented availability of and access to the drug/compound, device, and/or other materials needed, as appropriate, for the proposed duration of the study. The quality and stability of the product should be documented and commensurate with current FDA manufacturing standards applicable to the type and phase of product being developed (i.e., Quality System Regulation, Good Manufacturing Practice [GMP] guidelines).&#61623; The proposal/application should reflect the study team&#8217;s experience interacting with the FDA, including previous FDA submissions, if applicable.&#61623; The proposed clinical trial design should include clearly defined objectives and appropriate endpoints/outcome measures, and comply with current Good Clinical Practice (GCP) guidelines.&#61623; The proposal/application should include a clearly articulated statistical analysis plan, appropriate statistical expertise on the research team, and a power analysis reflecting sample size projections that will answer the objectives of the study.&#61623; The proposal/application should include a clearly articulated data management plan and use of an appropriate database to safeguard and maintain the integrity of the data. If FDA-regulated, the trial must use a 21 CFR 11-compliant database and appropriate data standards. For more on data standards, see https://www.fda.gov/downloads/Drugs/Development ApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM511237.pdf.&#61623; The proposal/application should include a clearly articulated safety management plan outlining how safety pharmacovigilance will be conducted, as applicable.&#61623; The proposal/application should include a clearly articulated clinical monitoring plan outlining how the study will be monitored for GCP compliance.&#61623; 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.&#61623; The proposal/application should include a Transition Plan (including potential funding and resources) as Attachment 12 showing how the product will progress to the next clinical trial phase and/or delivery to the market after the successful completion of the FY21 TBIPHRP CTA.&#61623; The proposal/application should clearly demonstrate strong institutional support and, if applicable, a commitment to serve as the FDA regulatory sponsor, ensuring all sponsor responsibilities described in 21 CFR 312, Subpart D, are fulfilled.&#61623; Funded 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 studies 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 D, for further details.Refer to Section II.D.6, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 2022. For additional information refer to Section II.F.1, Federal Award Notices.Relevance to Military Health: Relevance to the healthcare needs of Service Members, Veterans, military beneficiaries, and the American public is a key feature of this award. Investigators are encouraged to consider the following characteristics as examples of how a project may demonstrate relevance to military health:&#61623; Explanation of how the project addresses an aspect of TBI and/or psychological health that has direct relevance to the health and/or readiness of Service Members, Veterans, military beneficiaries, and the American public&#61623; Description of how the knowledge, information, products, or technologies gained from the proposed research could be implemented in a dual-use capacity to benefit the civilian population and also address a military need&#61623; Use of military or Veteran populations, samples, or datasets in the proposed research, if appropriate&#61623; Collaboration with DOD or Department of Veterans Affairs (VA) investigators or consultantsApplicants are encouraged to integrate and/or align their research projects with DOD and/or VA research laboratories and programs. Collaborations between researchers at military or Veterans institutions and non-military institutions are strongly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique data and research resources that the partners bring to the research effort, ultimately advancing TBI and psychological health research of significance to Service Members, Veterans, military beneficiaries, and the American public. A list of websites that may be useful in identifying additional information about ongoing DOD and VA areas of research interest or potential opportunities for collaboration can be found in Appendix 2.The CDMRP expects to allot approximately $58.5M to fund approximately 14 Research Level 1, 12 Research Level 2, and 2 Research Level 3 FY21 TBIPHRP CTA proposals/ applications. Funding of proposals/applications received is contingent upon the availability of federal funds for this program as well as the number of proposals/applications received, the quality and merit of the proposals/applications as evaluated by scientific and programmatic review, and the requirements of the government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY21 funding opportunity will be initially funded with FY21 funds, which will expire for use on September 30, 2027.The USAMRDC executes its extramural research program primarily through the awarding of contracts and assistance agreements (grants and cooperative agreements). The type of instrument used to reflect the business relationship between the organization and the government is at the discretion of the government, in accordance with the Federal Grant and Cooperative Agreement Act of 1977, as amended, 31 USC 6301-6308, which provides the legal criteria to select a procurement contract or an assistance agreement. An assistance agreement (grant or cooperative agreement) is appropriate when the federal government transfers a &#8220;thing of value&#8221; to a &#8220;state, local government,&#8221; or &#8220;other recipient&#8221; to carry out a public purpose of support or stimulation authorized by a law of the United States, instead of acquiring property or service for the direct benefit and use of the U.S. government. An assistance agreement can take the form of a grant or cooperative agreement. If &#8220;no substantial involvement&#8221; on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304).Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305) and the award will identify the specific substantial involvement. Substantial involvement may include collaboration, participation, or intervention in the research to be performed under the award.A contract is required when the principal purpose of the instrument is to acquire property or services for the direct benefit or use of the U.S. government.The award type, along with the start date, will be determined during the negotiation process.Please see Appendix 2, Section E, of the General Submission Instructions for more information.
GrantorContactEmailDescription: CDMRP Help Desk
GrantorContactText: CDMRP Help Desk &lt;br/&gt;Phone:  301-682-5507 &lt;br/&gt;Email:  help@eBRAP.org