The Defense Medical Research and Development Program (DMRDP) is offering the Clinical Trial Award-Regenerative Medicine, Pain, Sensory System (CTA-RPS). This grant supports early phase clinical trials (Phase 0-II, Class I-III device trials, excluding Phase III) for novel therapies and diagnostics. The primary purpose is to advance treatment for combat-related injuries, focusing on pain management, restoration of sensory systems (balance, hearing, vision), and regenerative medicine technologies. Projects must demonstrate safety and efficacy in human patients with debilitating trauma-related injuries to extremities, skin, sensory systems, or craniomaxillofacial areas. Research must be relevant to military service members and veterans, accelerating translation of proven interventions from animal models into clinical development. Funding is exclusively for clinical trials, not preclinical research.
Opportunity ID: 88473
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | W81XWH-12-DMRDP-CTA-RPS |
| Funding Opportunity Title: | Defense Medical Research and Development Program Clinical Trial Award – Regenerative Medicine, Pain, Sensory System |
| 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: | 5 |
| Assistance Listings: | 12.420 — Military Medical Research and Development |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Apr 19, 2011 |
| Last Updated Date: | Apr 20, 2011 |
| Original Closing Date for Applications: | Aug 25, 2011 |
| Current Closing Date for Applications: | Aug 25, 2011 |
| Archive Date: | Sep 24, 2011 |
| Estimated Total Program Funding: | $15,300,000 |
| 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: | The DMRDP Clinical Trial Award-Regenerative Medicine, Pain, Sensory System (CTA-RPS) is intended to support early phase clinical trials with the potential to have a major impact on treatment of combat-related injuries in the areas of pain, restoration of sensory systems (balance, hearing, and vision), and regenerative medicine technologies. All studies must be responsive to the health care needs of military service members and veterans, and all applications must specifically and clearly address the military relevance of the proposed research; however, the use of military populations in the clinical trial 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 injuries of the extremities, skin, sensory systems, or craniomaxillofacial area due to trauma. 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 device trials. Phase III clinical trials are not allowed. Projects of interest are those focused on testing and translating investigational interventions already proven in relevant definitive animal models, moving them into advanced clinical development. Funding from this award mechanism must support a clinical trial and cannot be used for preclinical research studies. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
301-682-5507
Email:help@cdmrp.org |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Apr 20, 2011 | ||
| Title changed to easily identify that this is a Defense program requirement. | Apr 20, 2011 | |
| Apr 20, 2011 |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | W81XWH-12-DMRDP-CTA-RPS |
| Funding Opportunity Title: | Defense Medical Research and Development Program Clinical Trial Award – Regenerative Medicine, Pain, Sensory System |
| 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: | 5 |
| Assistance Listings: | 12.420 — Military Medical Research and Development |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Apr 19, 2011 |
| Last Updated Date: | Apr 20, 2011 |
| Original Closing Date for Applications: | Aug 25, 2011 |
| Current Closing Date for Applications: | Aug 25, 2011 |
| Archive Date: | Sep 24, 2011 |
| Estimated Total Program Funding: | $15,300,000 |
| 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: | The DMRDP Clinical Trial Award-Regenerative Medicine, Pain, Sensory System (CTA-RPS) is intended to support early phase clinical trials with the potential to have a major impact on treatment of combat-related injuries in the areas of pain, restoration of sensory systems (balance, hearing, and vision), and regenerative medicine technologies. All studies must be responsive to the health care needs of military service members and veterans, and all applications must specifically and clearly address the military relevance of the proposed research; however, the use of military populations in the clinical trial 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 injuries of the extremities, skin, sensory systems, or craniomaxillofacial area due to trauma. 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 device trials. Phase III clinical trials are not allowed. Projects of interest are those focused on testing and translating investigational interventions already proven in relevant definitive animal models, moving them into advanced clinical development. Funding from this award mechanism must support a clinical trial and cannot be used for preclinical research studies. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
301-682-5507
Email:help@cdmrp.org |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | W81XWH-12-DMRDP-CTA-RPS |
| Funding Opportunity Title: | Defense Medical Research and Development Program Clinical Trial Award – Regenerative Medicine, Pain, Sensory System |
| 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: | 5 |
| Assistance Listings: | 12.420 — Military Medical Research and Development |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Apr 20, 2011 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Aug 25, 2011 |
| Archive Date: | Sep 24, 2011 |
| Estimated Total Program Funding: | $15,300,000 |
| 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: | The DMRDP Clinical Trial Award � Regenerative Medicine, Pain, Sensory System (CTA-RPS) is intended to support early phase clinical trials with the potential to have a major impact on treatment of combat-related injuries in the areas of pain, restoration of sensory systems (balance, hearing, and vision), and regenerative medicine technologies. All studies must be responsive to the health care needs of military service members and veterans, and all applications must specifically and clearly address the military relevance of the proposed research; however, the use of military populations in the clinical trial 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 injuries of the extremities, skin, sensory systems, or craniomaxillofacial area due to trauma. 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 device trials. Phase III clinical trials are not allowed. Projects of interest are those focused on testing and translating investigational interventions already proven in relevant definitive animal models, moving them into advanced clinical development. Funding from this award mechanism must support a clinical trial and cannot be used for preclinical research studies. A clinical trial 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. All applications should address at least one of the following Focus Areas: Regenerative Medicine: Proposed research should address strategies to promote tissue repair and reconstruction through the use of stem cells, progenitor cells, growth factors, biomaterials, and/or immunomodulation. The overall goal is to enable a patient�s own body to regenerate and/or repair lost or damaged tissue without significant scarring/fibrosis, with a return to normal function of the regenerated tissues. Studies addressing single tissue or composite tissue loss involving skeletal muscle, bone, nerve, vasculature, cartilage, and associated connective tissues in the following combat-related areas are of interest: � Burns ○ Off-the-shelf tissue-engineered composite skin substitute that is capable of being delivered in a single application for the treatment of full-thickness burns comprising greater than 40% of the body surface area that are unable to be closed during a single operation using autologous skin grafting. ○ Protein-based biomaterials delivered as a topical treatment to support the survival of damaged cells and tissues, and limit burn injury conversion of partial-thickness burns. ○ Burn therapy delivered as an intravenous infusion to limit burn injury progression and enhance healing in mid- to deep-second degree burns in critical areas and/or in burns comprising greater than 20% of the body surface area. ○ Burn therapy delivered as a topical treatment to limit burn injury progression and enhance healing in mid- to deep-second degree burns requiring debridement. ○ Point-of-care skin cell sprayer technology for treatment of full-thickness burns comprising greater than 40% of the body surface area that are unable to be closed during a single operation using autologous skin grafting. � Limb and Digit Injury ○ Cellular therapy for the treatment and consequences of large muscle volume loss and/or defects due to compartment syndrome, to restore both muscle volume and function and support neovascularization of regenerated muscle tissue. ○ Off-the-shelf material composed of extracellular matrix proteins for the treatment and consequences of massive musculotendinous volume loss and/or defects in a given compartment due to trauma that restores both muscle volume and function through growth of new functional skeletal muscle tissue. ○ Off-the-shelf nerve guide conduit composed of synthetic biodegradable biomaterials for repair of nerve gaps up to 8 cm in length in motor or mixed peripheral nerves. ○ Allogenic epineural nerve guide conduit for repair of nerve gaps up to 8 cm in length in motor or mixed peripheral nerves. ○ Tissue-lined stents for segmental peripheral arterial defects composed of a combination of nitinol or a synthetic biodegradable biomaterial and tissue with a shelf-life greater than three months. � Scarless Wound Healing ○ Wound therapy delivered as an intravenous infusion to promote wound healing and limit scarring after burns or trauma when challenged with ischemia-reperfusion. ○ Topical wound treatment for the management of partial- to full-thickness dermal wounds and scar contracture that promotes wound healing and limits scarring after burns or trauma. ○ Point-of-care autologous cellular therapy for the management of partial- to full-thickness dermal wounds and scar contracture. Pain: Research in the area of pain should include early phase clinical trials of novel pharmaceuticals or devices with the potential for significant impact on the alleviation of pain in wounded warriors. Novel analgesics are sought for the full spectrum of acute and chronic pain resulting from combat-related injuries. Preference will be given to those battlefield analgesics that allow the wounded warrior to remain alert enough to defend themselves. Vision: Projects of interest include early phase clinical trials of novel pharmaceuticals and devices focused on restoration and rehabilitation of vision loss resulting from combat-related injuries in the following areas: � Treatment of traumatic combat-related injuries to ocular structures and the visual system ○ Treatments for blast injury to ocular structures ○ Primary and alternative treatments for lid/adnexal/orbital/ocular injuries ○ Treatments for burn injury to ocular structures ○ Treatments to slow/stop loss of vision � Diagnosis, treatment, and mitigation of visual dysfunction associated with Traumatic Brain Injury (TBI) and combat-related injuries ○ Treatments for TBI-associated visual dysfunction ○ Treatment of traumatic optic neuropathy ○ Methods to test for visual dysfunction in the presence of cognitive impairment ○ Treatment for cellular dysfunction and loss following pre-chiasmal traumatic optic neuropathies � Vision Restoration ○ Regeneration of the visual system ○ Visual prosthetics ○ Rebuilding optic nerve and other ocular tissue following traumatic injury � Ocular Diagnostics ○ Clinical validation for diagnostic tools including injury classification, biomarkers, imaging, and electrodiagnostics � Vision Rehabilitation Strategies ○ Rehabilitation strategies and therapies to achieve �return to duty� status ○ Strategies and techniques for rehabilitation following restoration of eyesight ○ Treatment for low vision/no vision ○ Neural stimulation strategies for sensory substitution and vision repair ○ Treatments for binocular vision disorders Hearing and Balance: Research of interest includes early phase clinical assessments of restorative and rehabilitative technologies and strategies that are intended to support a full recovery to pre-injury functional capability (i.e. that of a deployable warfighter). Device, biological, and pharmaceutical-based technologies will be considered. Also included are clinical validation trials of diagnostic tools, particularly those that would provide information to support treatment strategy selection. Studies to support clinical practice guidelines for the application of existing and novel medical products will also be considered. Focus Areas in hearing and balance include: � Diagnostics ○ Objective diagnosis and characterization of tinnitus ○ Diagnosis and characterization of vestibular dysfunction � Intervention/Treatment ○ Treatment of tinnitus ○ Restoring and rehabilitating balance disorders, particularly using portable means ○ Therapeutic (drug/biologic) delivery methods for restoring hearing loss and vestibular function ○ Restoration of hearing loss ○ Treatment of central auditory processing disorders The CTA-RPS seeks applications for well-controlled clinical trials that are responsive to the above Focus Areas. Each application should propose only one clinical trial with a distinct study design. If the study proposed involves the use of a drug that has not been approved by the U.S. Food and Drug Administration (FDA) for its investigational use, an Investigational New Drug (IND) application to the FDA may be required and must be submitted to the FDA prior to grant submission. If the proposed study involves an Investigational Device that has not been approved or cleared by FDA for its investigational clinical use, the study may be required to comply with FDA Investigational Device Exemption (IDE) regulations. If applicable, the IDE application must be submitted prior to the grant submission. The Government reserves the right to withdraw funding if an IND or IDE required for conduct of the proposed research has not been acquired within 6 months of the award date. The following are important aspects of submission to the CTA-RPS: � The proposed clinical trial is expected to begin no later than 12 months after the award date. � The proposed intervention to be tested should offer significant potential impact for individuals with relevant injuries. � Inclusion of preliminary data relevant to the proposed research project is required. � The proposed research project should also be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature. � The application should demonstrate documented availability of and access to the drug/compound, device, and/or materials needed. � The application should demonstrate availability of and access to a suitable human subject population that will support a meaningful outcome for the study. The PI should discuss how accrual goals will be achieved, and how standards of care may impact the study population. � The proposed clinical trial should include clearly defined and appropriate endpoints. � The application should 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. � The application should include a study coordinator(s) who will guide the clinical 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. � The application should describe the clinical and regulatory expertise of the study team, including past experience with regulated medical product development. Partnerships between clinicians and bioengineers are encouraged. � The application must provide evidence of an existing IND/IDE or submission of an IND/IDE application, if applicable, by the time of the CTA-RPS submission. If the IND/IDE is not received within 6 months of the award date, the Government reserves the right to revoke funding. � The application should include a Transition Plan that describes a clear path to develop the trial product and how the project will continue to the next level 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:
PA HELP: 301-619-7079; cdmrp.pa@amedd.army.mil
eReceipt HELP: 301-682-5507; help@cdmrp.org Email:cdmrp.pa@amedd.army.mil |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | W81XWH-12-DMRDP-CTA-RPS |
| Funding Opportunity Title: | DoD Medical Research and Development Program Clinical Trial Award – Regenerative Medicine, Pain, Sensory System |
| 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: | 5 |
| Assistance Listings: | 12.420 — Military Medical Research and Development |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Apr 20, 2011 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Aug 25, 2011 |
| Archive Date: | Sep 24, 2011 |
| Estimated Total Program Funding: | $15,300,000 |
| 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: | The DMRDP Clinical Trial Award � Regenerative Medicine, Pain, Sensory System (CTA-RPS) is intended to support early phase clinical trials with the potential to have a major impact on treatment of combat-related injuries in the areas of pain, restoration of sensory systems (balance, hearing, and vision), and regenerative medicine technologies. All studies must be responsive to the health care needs of military service members and veterans, and all applications must specifically and clearly address the military relevance of the proposed research; however, the use of military populations in the clinical trial 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 injuries of the extremities, skin, sensory systems, or craniomaxillofacial area due to trauma. 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 device trials. Phase III clinical trials are not allowed. Projects of interest are those focused on testing and translating investigational interventions already proven in relevant definitive animal models, moving them into advanced clinical development. Funding from this award mechanism must support a clinical trial and cannot be used for preclinical research studies. A clinical trial 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. All applications should address at least one of the following Focus Areas: Regenerative Medicine: Proposed research should address strategies to promote tissue repair and reconstruction through the use of stem cells, progenitor cells, growth factors, biomaterials, and/or immunomodulation. The overall goal is to enable a patient�s own body to regenerate and/or repair lost or damaged tissue without significant scarring/fibrosis, with a return to normal function of the regenerated tissues. Studies addressing single tissue or composite tissue loss involving skeletal muscle, bone, nerve, vasculature, cartilage, and associated connective tissues in the following combat-related areas are of interest: � Burns ○ Off-the-shelf tissue-engineered composite skin substitute that is capable of being delivered in a single application for the treatment of full-thickness burns comprising greater than 40% of the body surface area that are unable to be closed during a single operation using autologous skin grafting. ○ Protein-based biomaterials delivered as a topical treatment to support the survival of damaged cells and tissues, and limit burn injury conversion of partial-thickness burns. ○ Burn therapy delivered as an intravenous infusion to limit burn injury progression and enhance healing in mid- to deep-second degree burns in critical areas and/or in burns comprising greater than 20% of the body surface area. ○ Burn therapy delivered as a topical treatment to limit burn injury progression and enhance healing in mid- to deep-second degree burns requiring debridement. ○ Point-of-care skin cell sprayer technology for treatment of full-thickness burns comprising greater than 40% of the body surface area that are unable to be closed during a single operation using autologous skin grafting. � Limb and Digit Injury ○ Cellular therapy for the treatment and consequences of large muscle volume loss and/or defects due to compartment syndrome, to restore both muscle volume and function and support neovascularization of regenerated muscle tissue. ○ Off-the-shelf material composed of extracellular matrix proteins for the treatment and consequences of massive musculotendinous volume loss and/or defects in a given compartment due to trauma that restores both muscle volume and function through growth of new functional skeletal muscle tissue. ○ Off-the-shelf nerve guide conduit composed of synthetic biodegradable biomaterials for repair of nerve gaps up to 8 cm in length in motor or mixed peripheral nerves. ○ Allogenic epineural nerve guide conduit for repair of nerve gaps up to 8 cm in length in motor or mixed peripheral nerves. ○ Tissue-lined stents for segmental peripheral arterial defects composed of a combination of nitinol or a synthetic biodegradable biomaterial and tissue with a shelf-life greater than three months. � Scarless Wound Healing ○ Wound therapy delivered as an intravenous infusion to promote wound healing and limit scarring after burns or trauma when challenged with ischemia-reperfusion. ○ Topical wound treatment for the management of partial- to full-thickness dermal wounds and scar contracture that promotes wound healing and limits scarring after burns or trauma. ○ Point-of-care autologous cellular therapy for the management of partial- to full-thickness dermal wounds and scar contracture. Pain: Research in the area of pain should include early phase clinical trials of novel pharmaceuticals or devices with the potential for significant impact on the alleviation of pain in wounded warriors. Novel analgesics are sought for the full spectrum of acute and chronic pain resulting from combat-related injuries. Preference will be given to those battlefield analgesics that allow the wounded warrior to remain alert enough to defend themselves. Vision: Projects of interest include early phase clinical trials of novel pharmaceuticals and devices focused on restoration and rehabilitation of vision loss resulting from combat-related injuries in the following areas: � Treatment of traumatic combat-related injuries to ocular structures and the visual system ○ Treatments for blast injury to ocular structures ○ Primary and alternative treatments for lid/adnexal/orbital/ocular injuries ○ Treatments for burn injury to ocular structures ○ Treatments to slow/stop loss of vision � Diagnosis, treatment, and mitigation of visual dysfunction associated with Traumatic Brain Injury (TBI) and combat-related injuries ○ Treatments for TBI-associated visual dysfunction ○ Treatment of traumatic optic neuropathy ○ Methods to test for visual dysfunction in the presence of cognitive impairment ○ Treatment for cellular dysfunction and loss following pre-chiasmal traumatic optic neuropathies � Vision Restoration ○ Regeneration of the visual system ○ Visual prosthetics ○ Rebuilding optic nerve and other ocular tissue following traumatic injury � Ocular Diagnostics ○ Clinical validation for diagnostic tools including injury classification, biomarkers, imaging, and electrodiagnostics � Vision Rehabilitation Strategies ○ Rehabilitation strategies and therapies to achieve �return to duty� status ○ Strategies and techniques for rehabilitation following restoration of eyesight ○ Treatment for low vision/no vision ○ Neural stimulation strategies for sensory substitution and vision repair ○ Treatments for binocular vision disorders Hearing and Balance: Research of interest includes early phase clinical assessments of restorative and rehabilitative technologies and strategies that are intended to support a full recovery to pre-injury functional capability (i.e. that of a deployable warfighter). Device, biological, and pharmaceutical-based technologies will be considered. Also included are clinical validation trials of diagnostic tools, particularly those that would provide information to support treatment strategy selection. Studies to support clinical practice guidelines for the application of existing and novel medical products will also be considered. Focus Areas in hearing and balance include: � Diagnostics ○ Objective diagnosis and characterization of tinnitus ○ Diagnosis and characterization of vestibular dysfunction � Intervention/Treatment ○ Treatment of tinnitus ○ Restoring and rehabilitating balance disorders, particularly using portable means ○ Therapeutic (drug/biologic) delivery methods for restoring hearing loss and vestibular function ○ Restoration of hearing loss ○ Treatment of central auditory processing disorders The CTA-RPS seeks applications for well-controlled clinical trials that are responsive to the above Focus Areas. Each application should propose only one clinical trial with a distinct study design. If the study proposed involves the use of a drug that has not been approved by the U.S. Food and Drug Administration (FDA) for its investigational use, an Investigational New Drug (IND) application to the FDA may be required and must be submitted to the FDA prior to grant submission. If the proposed study involves an Investigational Device that has not been approved or cleared by FDA for its investigational clinical use, the study may be required to comply with FDA Investigational Device Exemption (IDE) regulations. If applicable, the IDE application must be submitted prior to the grant submission. The Government reserves the right to withdraw funding if an IND or IDE required for conduct of the proposed research has not been acquired within 6 months of the award date. The following are important aspects of submission to the CTA-RPS: � The proposed clinical trial is expected to begin no later than 12 months after the award date. � The proposed intervention to be tested should offer significant potential impact for individuals with relevant injuries. � Inclusion of preliminary data relevant to the proposed research project is required. � The proposed research project should also be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature. � The application should demonstrate documented availability of and access to the drug/compound, device, and/or materials needed. � The application should demonstrate availability of and access to a suitable human subject population that will support a meaningful outcome for the study. The PI should discuss how accrual goals will be achieved, and how standards of care may impact the study population. � The proposed clinical trial should include clearly defined and appropriate endpoints. � The application should 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. � The application should include a study coordinator(s) who will guide the clinical 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. � The application should describe the clinical and regulatory expertise of the study team, including past experience with regulated medical product development. Partnerships between clinicians and bioengineers are encouraged. � The application must provide evidence of an existing IND/IDE or submission of an IND/IDE application, if applicable, by the time of the CTA-RPS submission. If the IND/IDE is not received within 6 months of the award date, the Government reserves the right to revoke funding. � The application should include a Transition Plan that describes a clear path to develop the trial product and how the project will continue to the next level 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:
PA HELP: 301-619-7079; cdmrp.pa@amedd.army.mil
eReceipt HELP: 301-682-5507; help@cdmrp.org Email:cdmrp.pa@amedd.army.mil |
Related Documents
Folder 88473 Full Announcement-1 -> dmrdp_fy12_cta-rps_pa_final for posting.pdf
Packages
| Agency Contact Information: | 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 | PKG00048990 | Apr 19, 2011 | Aug 25, 2011 | View |
Package 1
Mandatory forms
88473 RR_SF424_1_2-1.2.pdf
88473 PerformanceSite_1_4-1.4.pdf
88473 RR_Budget-1.1.pdf
88473 RR_KeyPersonExpanded_1_2-1.2.pdf
Optional forms
88473 RR_SubawardBudget30-1.2.pdf
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