This Department of Defense (DoD) DMRDP grant, the Military Infectious Diseases Clinical Trial Award (MID-CTA), supports early phase clinical trials (Phase 0-II) and testing of Class I, II, or III medical devices. The primary goal is to accelerate the translation of novel therapies and diagnostics for serious combat-related or trauma-induced wound infections, directly benefiting military Service Members and Veterans. This grant focuses on human subject studies demonstrating safety and efficacy from interventions proven in animal models. It excludes Phase III trials for FDA licensure. Applicants require strong preliminary data, scientific rationale, a clear statistical plan, and a comprehensive transition plan for continued development. This funding is exclusively for clinical trials, not preclinical research.
Opportunity ID: 235939
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | W81XWH-14-DMRDP-MID-CTA |
| Funding Opportunity Title: | DoD DMRDP Military Infectious Diseases Clinical Trial Award |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement Grant |
| Category of Funding Activity: | Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 4 |
| Assistance Listings: | 12.420 — Military Medical Research and Development |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Jun 04, 2013 |
| Last Updated Date: | Aug 26, 2013 |
| Original Closing Date for Applications: | Oct 04, 2013 |
| Current Closing Date for Applications: | Oct 17, 2013 |
| Archive Date: | Nov 03, 2013 |
| Estimated Total Program Funding: | $11,400,000 |
| Award Ceiling: | $0 |
| Award Floor: | $0 |
Eligibility
| Eligible Applicants: | Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Dept. of the Army — USAMRAA |
| Description: | Overview: The FY14 DMRDP MID-CTA is intended to support early phase clinical trials/ testing with the potential to have a major impact on treatment of combat-related or trauma-induced wound infections. These studies must be responsive to the health care needs of military Service Members and Veterans; however, the use of military populations in the clinical trial/ testing is not a requirement. Proposed projects should be designed to demonstrate the safety and efficacy of novel therapies and diagnostics in human patients suffering from serious, debilitating combat-related or trauma-related wound infections. The purpose of such demonstrations is to accelerate translation of greater medical capabilities to patients; this can range from proof of concept (i.e., first in human or Phase 0) trials through Phase II clinical trials, as well as Class I, II, or III medical device trials/testing. Phase III trials for FDA licensure of drugs or definitive testing for device or assay clearance by the FDA will NOT be permitted under this Program Announcement/Funding Opportunity. Projects of interest are those focused on testing and translating investigational interventions or devices already proven in relevant definitive animal models and moving those interventions or devices into advanced clinical development.Funding from this award mechanism must support a clinical trial/testing and cannot be used for preclinical research studies. A clinical trial/testing is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention or other) is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. For this Program Announcement/Funding Opportunity the term device includes diagnostics (e.g., in vivo, in vitro, and/or biomarkers). In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. For this Program Announcement/Funding Opportunity the term human subjects refer to individuals who will be recruited for or who will participate in the proposed clinical trial. For more information onclinical trials and phase/class of study, a Human Subject Resource Document is provided athttps://cdmrp.org/Program_Announcements_and_Forms/.If the proposed trial involves the use of a drug that has not been approved by the FDA for its investigational use, then an Investigational New Drug (IND) application may be required. If the proposed study involves an investigational device that has not been approved or cleared by the FDA for its investigational clinical use, the study may be required to comply with the FDA Investigational Device Exemption (IDE) regulations. If the documented status of the IND or IDE has not been obtained within 6 months of the award date, the award may be terminated for failure to comply with a material provision of the award.All of the following are important aspects of FY14 DMRDP MID-CTA application submission. The application should: Include a clinical trial that begins no later than 12 months after the award date, if a clinical trial is proposed. Include preliminary data relevant to the proposed research project. Preliminary data relevant to the proposed research are required; any unpublished preliminary data originating from the laboratory of the Principal Investigator (PI), collaborator(s), or subawardee(s) named on this application should be included. Be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature as documented in the application. Demonstrate and document availability of and access to the drug/compound, device, and/or other materials needed. Demonstrate availability of and access to a suitable human subject population that will support a meaningful outcome for the study. Include a discussion of how accrual goals will be achieved, and how standards of care may impact the study population. Describe appropriate and clearly defined endpoints for the proposed clinical trial/testing. Include a clearly articulated statistical analysis plan, as well as appropriate statistical expertise and a power analysis reflecting sample size projections that will clearly answer the objectives of the study. Discuss the potential impact of the study results on prevention and/or treatment of combat-related or trauma-induced wound infections. Include a study coordinator(s) who will guide the clinical trial protocol through the local Institutional Review Board (IRB) of record and other regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate human subject accrual. Demonstrate institutional support and access to institutional resources Include a Transition Plan that describes a clear path to further develop the trial product and how the project will continue to the next level of development after the end of the award period of performance. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
CDMRP Help Desk
301-682-5507 Email:help@cdmrp.org |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| The closing date for receipt of proposals has been extended. Please see revised Program Announcement. | Aug 26, 2013 | |
| The purpose of this modification is to extend the due date for receipt of applications. Please see revised Program Announcement. | Aug 26, 2013 | |
| Jul 30, 2013 |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | W81XWH-14-DMRDP-MID-CTA |
| Funding Opportunity Title: | DoD DMRDP Military Infectious Diseases Clinical Trial Award |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement Grant |
| Category of Funding Activity: | Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 4 |
| Assistance Listings: | 12.420 — Military Medical Research and Development |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Jun 04, 2013 |
| Last Updated Date: | Aug 26, 2013 |
| Original Closing Date for Applications: | Oct 04, 2013 |
| Current Closing Date for Applications: | Oct 17, 2013 |
| Archive Date: | Nov 03, 2013 |
| Estimated Total Program Funding: | $11,400,000 |
| Award Ceiling: | $0 |
| Award Floor: | $0 |
Eligibility
| Eligible Applicants: | Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Dept. of the Army — USAMRAA |
| Description: | Overview: The FY14 DMRDP MID-CTA is intended to support early phase clinical trials/ testing with the potential to have a major impact on treatment of combat-related or trauma-induced wound infections. These studies must be responsive to the health care needs of military Service Members and Veterans; however, the use of military populations in the clinical trial/ testing is not a requirement. Proposed projects should be designed to demonstrate the safety and efficacy of novel therapies and diagnostics in human patients suffering from serious, debilitating combat-related or trauma-related wound infections. The purpose of such demonstrations is to accelerate translation of greater medical capabilities to patients; this can range from proof of concept (i.e., first in human or Phase 0) trials through Phase II clinical trials, as well as Class I, II, or III medical device trials/testing. Phase III trials for FDA licensure of drugs or definitive testing for device or assay clearance by the FDA will NOT be permitted under this Program Announcement/Funding Opportunity. Projects of interest are those focused on testing and translating investigational interventions or devices already proven in relevant definitive animal models and moving those interventions or devices into advanced clinical development.Funding from this award mechanism must support a clinical trial/testing and cannot be used for preclinical research studies. A clinical trial/testing is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention or other) is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. For this Program Announcement/Funding Opportunity the term device includes diagnostics (e.g., in vivo, in vitro, and/or biomarkers). In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. For this Program Announcement/Funding Opportunity the term human subjects refer to individuals who will be recruited for or who will participate in the proposed clinical trial. For more information onclinical trials and phase/class of study, a Human Subject Resource Document is provided athttps://cdmrp.org/Program_Announcements_and_Forms/.If the proposed trial involves the use of a drug that has not been approved by the FDA for its investigational use, then an Investigational New Drug (IND) application may be required. If the proposed study involves an investigational device that has not been approved or cleared by the FDA for its investigational clinical use, the study may be required to comply with the FDA Investigational Device Exemption (IDE) regulations. If the documented status of the IND or IDE has not been obtained within 6 months of the award date, the award may be terminated for failure to comply with a material provision of the award.All of the following are important aspects of FY14 DMRDP MID-CTA application submission. The application should: Include a clinical trial that begins no later than 12 months after the award date, if a clinical trial is proposed. Include preliminary data relevant to the proposed research project. Preliminary data relevant to the proposed research are required; any unpublished preliminary data originating from the laboratory of the Principal Investigator (PI), collaborator(s), or subawardee(s) named on this application should be included. Be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature as documented in the application. Demonstrate and document availability of and access to the drug/compound, device, and/or other materials needed. Demonstrate availability of and access to a suitable human subject population that will support a meaningful outcome for the study. Include a discussion of how accrual goals will be achieved, and how standards of care may impact the study population. Describe appropriate and clearly defined endpoints for the proposed clinical trial/testing. Include a clearly articulated statistical analysis plan, as well as appropriate statistical expertise and a power analysis reflecting sample size projections that will clearly answer the objectives of the study. Discuss the potential impact of the study results on prevention and/or treatment of combat-related or trauma-induced wound infections. Include a study coordinator(s) who will guide the clinical trial protocol through the local Institutional Review Board (IRB) of record and other regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate human subject accrual. Demonstrate institutional support and access to institutional resources Include a Transition Plan that describes a clear path to further develop the trial product and how the project will continue to the next level of development after the end of the award period of performance. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
CDMRP Help Desk
301-682-5507 Email:help@cdmrp.org |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | W81XWH-14-DMRDP-MID-CTA |
| Funding Opportunity Title: | DoD DMRDP Military Infectious Diseases Clinical Trial Award |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement Grant |
| Category of Funding Activity: | Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 4 |
| Assistance Listings: | 12.420 — Military Medical Research and Development |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Aug 26, 2013 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Oct 04, 2013 |
| Archive Date: | Nov 03, 2013 |
| Estimated Total Program Funding: | $11,400,000 |
| Award Ceiling: | $0 |
| Award Floor: | $0 |
Eligibility
| Eligible Applicants: | Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Dept. of the Army — USAMRAA |
| Description: | Overview: The FY14 DMRDP MID-CTA is intended to support early phase clinical trials/ testing with the potential to have a major impact on treatment of combat-related or trauma-induced wound infections. These studies must be responsive to the health care needs of military Service Members and Veterans; however, the use of military populations in the clinical trial/ testing is not a requirement. Proposed projects should be designed to demonstrate the safety and efficacy of novel therapies and diagnostics in human patients suffering from serious, debilitating combat-related or trauma-related wound infections. The purpose of such demonstrations is to accelerate translation of greater medical capabilities to patients; this can range from proof of concept (i.e., first in human or Phase 0) trials through Phase II clinical trials, as well as Class I, II, or III medical device trials/testing. Phase III trials for FDA licensure of drugs or definitive testing for device or assay clearance by the FDA will NOT be permitted under this Program Announcement/Funding Opportunity. Projects of interest are those focused on testing and translating investigational interventions or devices already proven in relevant definitive animal models and moving those interventions or devices into advanced clinical development. Funding from this award mechanism must support a clinical trial/testing and cannot be used for preclinical research studies. A clinical trial/testing is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention or other) is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. For this Program Announcement/Funding Opportunity the term device includes diagnostics (e.g., in vivo, in vitro, and/or biomarkers). In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. For this Program Announcement/Funding Opportunity the term human subjects refer to individuals who will be recruited for or who will participate in the proposed clinical trial. For more information on clinical trials and phase/class of study, a Human Subject Resource Document is provided at https://cdmrp.org/Program_Announcements_and_Forms/. If the proposed trial involves the use of a drug that has not been approved by the FDA for its investigational use, then an Investigational New Drug (IND) application may be required. If the proposed study involves an investigational device that has not been approved or cleared by the FDA for its investigational clinical use, the study may be required to comply with the FDA Investigational Device Exemption (IDE) regulations. If the documented status of the IND or IDE has not been obtained within 6 months of the award date, the award may be terminated for failure to comply with a material provision of the award. All of the following are important aspects of FY14 DMRDP MID-CTA application submission. The application should: Include a clinical trial that begins no later than 12 months after the award date, if a clinical trial is proposed. Include preliminary data relevant to the proposed research project. Preliminary data relevant to the proposed research are required; any unpublished preliminary data originating from the laboratory of the Principal Investigator (PI), collaborator(s), or subawardee(s) named on this application should be included. Be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature as documented in the application. Demonstrate and document availability of and access to the drug/compound, device, and/or other materials needed. Demonstrate availability of and access to a suitable human subject population that will support a meaningful outcome for the study. Include a discussion of how accrual goals will be achieved, and how standards of care may impact the study population. Describe appropriate and clearly defined endpoints for the proposed clinical trial/testing. Include a clearly articulated statistical analysis plan, as well as appropriate statistical expertise and a power analysis reflecting sample size projections that will clearly answer the objectives of the study. Discuss the potential impact of the study results on prevention and/or treatment of combat-related or trauma-induced wound infections. Include a study coordinator(s) who will guide the clinical trial protocol through the local Institutional Review Board (IRB) of record and other regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate human subject accrual. Demonstrate institutional support and access to institutional resources Include a Transition Plan that describes a clear path to further develop the trial product and how the project will continue to the next level of development after the end of the award period of performance. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
CDMRP Help Desk
301-682-5507 Email:help@cdmrp.org |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | W81XWH-14-DMRDP-MID-CTA |
| Funding Opportunity Title: | DoD DMRDP Military Infectious Diseases Clinical Trial Award |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement Grant |
| Category of Funding Activity: | Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 4 |
| Assistance Listings: | 12.420 — Military Medical Research and Development |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jul 30, 2013 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Oct 04, 2013 |
| Archive Date: | Nov 03, 2013 |
| Estimated Total Program Funding: | $11,400,000 |
| Award Ceiling: | $0 |
| Award Floor: | $0 |
Eligibility
| Eligible Applicants: | Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Dept. of the Army — USAMRAA |
| Description: | Overview: The FY14 DMRDP MID-CTA is intended to support early phase clinical trials/ testing with the potential to have a major impact on treatment of combat-related or trauma-induced wound infections. These studies must be responsive to the health care needs of military Service Members and Veterans; however, the use of military populations in the clinical trial/ testing is not a requirement. Proposed projects should be designed to demonstrate the safety and efficacy of novel therapies and diagnostics in human patients suffering from serious, debilitating combat-related or trauma-related wound infections. The purpose of such demonstrations is to accelerate translation of greater medical capabilities to patients; this can range from proof of concept (i.e., first in human or Phase 0) trials through Phase II clinical trials, as well as Class I, II, or III medical device trials/testing. Phase III trials for FDA licensure of drugs or definitive testing for device or assay clearance by the FDA will NOT be permitted under this Program Announcement/Funding Opportunity. Projects of interest are those focused on testing and translating investigational interventions or devices already proven in relevant definitive animal models and moving those interventions or devices into advanced clinical development. Funding from this award mechanism must support a clinical trial/testing and cannot be used for preclinical research studies. A clinical trial/testing is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention or other) is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. For this Program Announcement/Funding Opportunity the term device includes diagnostics (e.g., in vivo, in vitro, and/or biomarkers). In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. For this Program Announcement/Funding Opportunity the term human subjects refer to individuals who will be recruited for or who will participate in the proposed clinical trial. For more information on clinical trials and phase/class of study, a Human Subject Resource Document is provided at https://cdmrp.org/Program_Announcements_and_Forms/. If the proposed trial involves the use of a drug that has not been approved by the FDA for its investigational use, then an Investigational New Drug (IND) application may be required. If the proposed study involves an investigational device that has not been approved or cleared by the FDA for its investigational clinical use, the study may be required to comply with the FDA Investigational Device Exemption (IDE) regulations. If the documented status of the IND or IDE has not been obtained within 6 months of the award date, the award may be terminated for failure to comply with a material provision of the award. All of the following are important aspects of FY14 DMRDP MID-CTA application submission. The application should: Include a clinical trial that begins no later than 12 months after the award date, if a clinical trial is proposed. Include preliminary data relevant to the proposed research project. Preliminary data relevant to the proposed research are required; any unpublished preliminary data originating from the laboratory of the Principal Investigator (PI), collaborator(s), or subawardee(s) named on this application should be included. Be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature as documented in the application. Demonstrate and document availability of and access to the drug/compound, device, and/or other materials needed. Demonstrate availability of and access to a suitable human subject population that will support a meaningful outcome for the study. Include a discussion of how accrual goals will be achieved, and how standards of care may impact the study population. Describe appropriate and clearly defined endpoints for the proposed clinical trial/testing. Include a clearly articulated statistical analysis plan, as well as appropriate statistical expertise and a power analysis reflecting sample size projections that will clearly answer the objectives of the study. Discuss the potential impact of the study results on prevention and/or treatment of combat-related or trauma-induced wound infections. Include a study coordinator(s) who will guide the clinical trial protocol through the local Institutional Review Board (IRB) of record and other regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate human subject accrual. Demonstrate institutional support and access to institutional resources Include a Transition Plan that describes a clear path to further develop the trial product and how the project will continue to the next level of development after the end of the award period of performance. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
CDMRP Help Desk
301-682-5507 Email:help@cdmrp.org |
Related Documents
Folder 235939 Full Announcement-1 -> dmrdp fy14 mid-cta pa_gg2.pdf
Folder 235939 Full Announcement-1 -> fy14_ind-ide form.pdf
Packages
| Agency Contact Information: | CDMRP Help Desk 301-682-5507 Email: help@cdmrp.org |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 12.420 | PKG00179021 | Jun 04, 2013 | Oct 17, 2013 | View |
Package 1
Mandatory forms
235939 RR_SF424_1_2-1.2.pdf
235939 PerformanceSite_1_4-1.4.pdf
235939 RR_Budget-1.1.pdf
235939 RR_KeyPersonExpanded_1_2-1.2.pdf
Optional forms
235939 RR_SubawardBudget30-1.2.pdf
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