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

DoD Amyotrophic Lateral Sclerosis, Pilot Clinical Trial Award

The FY22 ALSRP Pilot Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of ALS. Projects may range from phase 1 to sma...

80
match
Deadline 1424 days ago Location Alabama Type grant Level Federal Closed posted Mar 16, 2022
✦ AI Summary
  • Who can apply: Federal-level applicants (see eligibility for details).
  • Funding amount: total funding pool ~$9,600,000.
  • Next deadline: July 28, 2022.
  • Issued by: Defense Health Agency Contracting Activity - DHACA.
How was this generated?

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.

AI-generated. Always verify with the official source.

Deadline
1424 days ago
Jul 28, 2022
Total pool
$9.6M

About this opportunity

The FY22 ALSRP Pilot Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of ALS. Projects may range from phase 1 to small-scale phase 2 trials and should aim to de-risk and inform the design of more advanced trials by investigating application, and therapeutic efficacy in relevant patient populations. Clinical trials may be designed to evaluate promising devices with anticipated therapeutic impact that is supported by strong scientific rationale and existing preclinical data. Potential impact is not whether a therapy is ready at the conclusion of the trial, but rather if the outcomes will improve and accelerate future larger trials. Applications submitted to this award can have outcomes that focus on specific subpopulations of ALS patients or potentially even individual patients.Applicants not investigating a therapeutic, but proposing a clinical trial to optimize established ALS clinical care, must submit under a lower total direct cost Clinical Care Tier. Types of efforts that will be supported under this tier include but are not limited to optimization of respiratory care strategies, improvements to approved devices and assistive technologies, and/or specific symptom management strategies. The capacity for near-term impact on patient care is an important component of the Clinical Care Tier.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. For more information, a Human Subject Resource Document is provided at https://cdmrp.army.mil/pubs/pdf/Human%20Subjects%20Resource%20Document.pdf. Principal Investigators (PIs) seeking funding for a preclinical research project should consider one of the other FY22 ALSRP program announcements being offered. For information about these award mechanisms, see https://cdmrp.army.mil/funding/alsrpThe requested budget for the clinical trial must be justified and appropriate to the scope proposed. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Funding for therapeutics must include plans to generate compelling biomarker data. pharmacodynamic biomarkers are critical to improving trial design, patient interpretation. Applicants must clearly describe a biomarker-driven approach and its potential to de-risk and improve the design of anticipated later-stage trials. For further description, see Attachment 13: Biomarker Statement. 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.For further information on early-phase clinical trial design and biomarker their use in ALS clinical trials, it is recommended that applicants consult the following resources:• Food and Drug Administration (FDA) Guidance Document – “Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry.” September 2019. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/amyotrophic-lateral-sclerosis-developing-drugs-treatment-guidance-industry• Verber NS, Shepheard SR, Sassani M, et al. 2019. Biomarkers in motor neuron disease: A state of the art review. Frontiers in Neurology (10):291 https://www.frontiersin.org/articles/10.3389/fneur.2019.00291/full• van den Berg LH, Sorenson E, Gronseth G, et al. 2019. Revised Airlie House consensus guidelines for design and implementation of ALS clinical trials.

Funding agency

Tags

Want help applying?

Our specialists will check your eligibility, prepare the application, and walk you through every step — for free. Create a free account →

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.

Apply on agency site
Tip from our team:

Read the agency's eligibility checklist before you start — it's almost always shorter than the full NOFO and will tell you in 90 seconds whether to keep going.

Need help getting in touch with the right agency contact?

Create a free account and our specialists will guide you through the application end-to-end.

Source documents

View on agency site
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 ID338706
PostedMar 16, 2022

Frequently asked questions

No FAQs yet.

Have a question about this fund? Sign in to open a ticket about this fund.