DoD Amyotrophic Lateral Sclerosis, Therapeutic/Biomarker Pilot Trial Award — Defense Health Agency Contracting Activity - DHACA funding opportunity
Defense Health Agency Contracting Activity - DHACA · Federal agency

DoD Amyotrophic Lateral Sclerosis, Therapeutic/Biomarker Pilot Trial Award

The ALSRP Therapeutic/Biomarker Pilot Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of ALS. Clinical trials may be designe...

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Deadline 1802 days ago Location Alabama Type grant Level Federal Closed posted Feb 16, 2021
✦ AI Summary
  • Who can apply: Federal-level applicants (see eligibility for details).
  • Funding amount: total funding pool ~$9,600,000.
  • Next deadline: July 15, 2021.
  • Issued by: Defense Health Agency Contracting Activity - DHACA.
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The “key facts” mode pulls structured fields directly from the official source posting (amount, deadline, eligibility tags). The AI mode adds a short plain-English narrative on top, generated from the same source. Always verify with the agency before applying.

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Deadline
1802 days ago
Jul 15, 2021
Total pool
$9.6M

About this opportunity

The ALSRP Therapeutic/Biomarker Pilot Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of ALS. Clinical trials may be designed to evaluate promising devices with anticipated therapeutic impact that is supported by strong scientific rationale and existing preclinical data. Projects may range from Phase 1 to small-scale Phase 2 trials and should be designed to de-risk and inform the design of more advanced trials, by investigating application, and therapeutic efficacy in relevant patient populations. Funding from this award mechanism must support a clinical trial and the trial design must include plans to generate compelling biomarker data. Principal Investigators (PIs) seeking funding for a preclinical research project or standalone biomarker development should alternatively consider one of the other FY21 ALSRP Funding Opportunity Announcements. Biomarker development and characterization can include target engagement biomarkers, pharmacodynamic biomarkers to measure the biological effect of an investigational therapeutic, and/or predictive/cohort-selective biomarkers that indicate whether a specific therapy will be effective in an individual patient or patient subgroup. Applicants must clearly describe the biomarker(s) and its potential to de-risk and improve the design of anticipated later-stage trials. For further description, see Attachment 8: Biomarker Statement. 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. More information is provided in the Human Subject Resource Document at https://cdmrp.army.mil/pubs/pdf/Human%20Subjects%20Resource%20Document.pdf. The following are important aspects of the FY21 ALSRP Therapeutic/Biomarker Pilot Trial Award: • Impact: The outcomes of the proposed project should directly and substantially de-risk and inform the design of anticipated later phase trials of the intervention under investigation. The intervention itself must offer significant potential impact for individuals affected by ALS, to include genetic or phenotypic patient subpopulations. • Rationale: Both the anticipated therapeutic impact of the intervention and the proposed clinical trial outcomes must be supported by strong scientific rationale that is established through critical review and analysis of the relevant literature and preliminary data. • Preliminary Data: Inclusion of preliminary data relevant to the proposed clinical trial is required. • Access to Patient Population: The application must demonstrate access to a suitable patient population to accomplish the project goals within the proposed timeline. The application should include a discussion of how accrual goals will be achieved and how standards of care may impact the study population. • Access to Therapeutic: The application should include documentation attesting to the availability of 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 ( Quality System Regulation, Good Manufacturing Practice guidelines). • Trial Design: The proposed clinical trial design should include clearly defined objectives and appropriate endpoints/outcome measures, and comply with current Good Clinical Practice (GCP) guidelines. • Statistical Plan: The 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.

Funding agency

Defense Health Agency Contracting Activity - DHACA
Federal agency

Tags

Healthcare & Biotech Manufacturing Arts & Culture Education & Research Transportation & Logistics Science, Tech & Engineering (STEM)
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Who can apply

Eligibility details aren't on file yet — check the agency source link in the Documents tab for the latest rules.

Geographic eligibility

  • Alabama
  • Alaska
  • Arizona
  • Arkansas
  • California
  • Colorado
  • Connecticut
  • Delaware
  • Florida
  • Georgia
  • Hawaii
  • Idaho
  • Illinois
  • Indiana
  • Iowa
  • Kansas
  • Kentucky
  • Louisiana
  • Maine
  • Maryland
  • Massachusetts
  • Michigan
  • Minnesota
  • Mississippi
  • Missouri
  • Montana
  • Nebraska
  • Nevada
  • New Hampshire
  • New Jersey
  • New Mexico
  • New York
  • North Carolina
  • North Dakota
  • Ohio
  • Oklahoma
  • Oregon
  • Pennsylvania
  • Rhode Island
  • South Carolina
  • South Dakota
  • Tennessee
  • Texas
  • Utah
  • Vermont
  • Virginia
  • Washington
  • West Virginia
  • Wisconsin
  • Wyoming
  • District of Columbia

How to apply

We don't have application instructions on file yet — head straight to the official source.

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Source documents

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Canonical NOFO, application packet, and forms
No supplemental documents yet.

Direct downloads (NOFO PDFs, application forms, FAQs) will appear here once our team attaches them. For now, the agency site has the canonical packet.

Citation details

Source systemgrants.gov
Source ID331547
PostedFeb 16, 2021

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