DoD Gulf War Illness, Therapeutic/Biomarker Trial Award

Description

The FY21 GWIRP Therapeutic/Biomarker Trial Award supports large-scale, pivotal (e.g., phase 2b-3) clinical trials that will revolutionize the clinical management of GWI. The Therapeutic/ Biomarker Trial Award targets the Confirmation phase of the research pipeline as outlined in Section II.A.2. The proposed research should lead to an approach that is fundamentally better than interventions already approved or in clinical development. Objective biomarkers to measure the biological effect of an investigational therapeutic or predictive/cohort-selective biomarkers that indicate whether a specific therapy will be effective in an individual Gulf War Veteran or Gulf War Veteran subgroup must be included in the trial design.Development of markers for the purposes of diagnosis, prognosis, or measurement of disease progression without consideration of the therapeutic development process will not be supported.The FY21 GWIRP Therapeutic/Biomarker Trial Award supports clinical trials; therefore, all applications must address the FY21 GWIRP Overarching Challenge of “Treatments.” In addition, applicants may consider The Gulf War Illness Landscape and the GWIRP’s mission and address any of the other FY21 GWIRP Overarching Challenges or a different challenge identified and justified in the application.Principal Investigators (PIs) are expected to have experience in successfully leading large-scale projects and demonstrated ability (through personal experience or via a commitment from a collaborating clinical investigator) to implement a clinical project successfully.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 placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. Funded clinical 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 the Code of Federal Regulations, Title 32, Part 219 (2 CFR 219).Clinical 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.Investigators seeking funding for a preclinical research project should consider one of the other FY21 GWIRP program announcements being offered.For proposed research that will require U.S. Food and Drug Administration (FDA) involvement, project readiness requirements at the time of application submission include: proof of availability of and access to clinical reagents (e.g., therapeutics) that meet regulatory compliance guidelines, proof of availability of and access to appropriate subject population(s), validated projections for patient recruitment, and submission of an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application to the FDA that meets all requirements under 21 CFR 312. It is the responsibility of the applicant to provide evidence from the IRB of record or the FDA if an IND or IDE is not required.If an IND is required, the IND application must be submitted to the FDA by the FY21 GWIRP Therapeutic/Biomarker Trial Award 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/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm.If an IDE is required, the IDE application must be submitted to the FDA by the FY21 GWIRP Therapeutic/Biomarker Trial Award 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.Refer to Attachment 8, Regulatory Strategy, for additional details on documentation of FDA applications. The government reserves the right to withdraw funding if an IND or IDE application and/or international regulatory application is necessary but has not been submitted prior to the application submission deadline.Biorepository Contribution Option: In FY17, the GWIRP awarded infrastructure support for a Gulf War Illness Biorepository. The Boston Biorepository, Recruitment, and Integrative Network (BBRAIN) for GWI has now been established for the retention and distribution of Gulf War Veteran biospecimens and/or data related to GWI research. Applicants to the FY21 GWIRP are encouraged to contribute Gulf War Veteran biospecimens and data to this repository network. The FY21 GWIRP Therapeutic/Biomarker Trial Award offers a nested Biorepository Contribution Option with higher levels of funding for qualified applications as described in Section II.D.5, Funding Restrictions. See Attachment 13, Option Statements for additional submission requirements. Applicants interested in collaborating with this network should refer to the GWIRP Supported Initiatives on the GWIRP website.Clinical Consortium Collaboration Option: In FY17, the GWIRP awarded a Clinical Consortium Award to create a network of institutions focused on designing and executing phase 1 and 2 clinical trials. The Gulf War Illness Clinical Trials and Interventions Consortium (GWICTIC) has now been established to investigate promising therapeutics for GWI. Applicants to the FY21 GWIRP are encouraged to make use of the established infrastructure of the GWICTIC, such as recruitment networks, existing protocols, Common Data Elements (CDEs), and data management procedures. Clinical Consortium Collaboration Option applications shall adhere to the GWICTIC policies and procedures with respect to biospecimens and data and therefore are not eligible to also submit under the Biorepository Contribution Option. A letter of collaboration from the GWICTIC is required, outlining the services that will be shared to bring value to the government. The FY21 GWIRP Therapeutic/Biomarker Trial Award offers a nested Clinical Consortium Collaboration Option with higher levels of funding for qualified applications as described in Section II.D.5, Funding Restrictions. See Attachment 13, Option Statements for additional submission requirements.The following are important aspects of the GWIRP Therapeutic/Biomarker Trial Award, in addition to the items outlined above: Preliminary Data: Inclusion of preliminary data from the field of GWI relevant to the proposed clinical trial is required. Start Time: The proposed clinical trial is expected to begin no later than 12 months after the award date, or 18 months after the award date for FDA-regulated studies. Recruitment Plan and Milestones: The application must include a sound subject recruitment and retention plan and demonstrate availability of and access to a suitable Gulf War Veteran population that will support a meaningful, statistically significant outcome for the study. A resource containing guidance for successful access to Gulf War Veterans titled, “General Guidance for Gulf War Veteran Subject Outreach and Recruitment,” can be found on the GWIRP webpage at https://cdmrp.army.mil/gwirp/pdfs/General%20_Guidance_for_ Gulf_War_Veteran_Outreach_and_Recruitment.pdf. Successful applicants will work with USAMRAA to establish milestones for human subject recruitment. Continued support for the project will be based upon satisfactory progress in meeting the established milestones. Therapeutic Access: The application should demonstrate 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). FDA Experience: If applicable, the application should demonstrate experience on the study team in interacting with the FDA, including previous FDA submissions. Statistical Analysis Plan: The application should include a clearly articulated statistical analysis plan, demonstrate appropriate statistical expertise on the research team, and include a power analysis reflecting sample size projections that will answer the objectives of the study. Safety Management Plan: The application should include a clearly articulated safety management plan outlining how safety pharmacovigilance will be conducted, as applicable. Clinical Monitoring Plan: The application should include a clearly articulated clinical monitoring plan outlining how the study will be monitored for Good Clinical Practice (GCP) compliance. Data Managemen

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