Opportunity Information: Apply for HT9425 23 ALSRP PCTA
The DOD Amyotrophic Lateral Sclerosis (ALS) Pilot Clinical Trial Award (FY23 ALSRP PCTA; opportunity number HT9425 23 ALSRP PCTA) is a Department of Defense funding opportunity administered through the U.S. Army Medical Research Acquisition Activity (USAMRAA) to speed the launch of early-stage clinical trials that could meaningfully change how ALS is treated or managed. The core emphasis is on rapid, well-justified studies that generate decision-quality evidence to guide the next steps, rather than on completing a full development program within the award period. In practical terms, the program is looking for trials that reduce uncertainty and help the field move faster into larger, more definitive studies by showing whether an approach is safe, feasible, measurable with appropriate biomarkers, and suggestive of benefit in the right patient population.
Projects supported under this award typically fall in the phase 1 to small, early phase 2 range. The intent is to support trials that can answer high-value questions such as: is the intervention safe enough to continue development, can the protocol and recruitment approach work in the real-world ALS setting, do proposed biomarkers perform as expected in patients, and is there a signal of therapeutic efficacy that justifies a larger, more expensive, and more time-intensive trial. The interventions may include drugs, biologics, or devices, but they need to be backed by a strong scientific rationale and supported by preliminary clinical experience and/or solid preclinical data. The program frames "impact" as the ability of the trial results to improve and accelerate future trials (for example, by validating endpoints, identifying responsive subgroups, establishing dosing or device parameters, or demonstrating feasibility across sites), not whether the therapy is ready for widespread clinical use at the end of the project.
The opportunity also recognizes the heterogeneity of ALS and explicitly allows outcomes and designs that focus on specific ALS subpopulations, and in some cases even highly individualized approaches, provided the trial remains clinically meaningful and capable of informing subsequent research or care. This flexibility can be important for testing targeted therapies, genotype- or phenotype-informed approaches, or biomarker-defined cohorts where a one-size-fits-all trial is unlikely to be informative.
In addition to trials of new or emerging therapeutics, the announcement includes a separate pathway for studies that are not testing a novel therapeutic but are instead optimizing established ALS clinical care. These applications must be submitted under a Clinical Care Tier with a lower allowable total direct cost. The types of projects envisioned here include practical, patient-centered efforts such as improving respiratory care strategies, refining or enhancing approved devices and assistive technologies, developing or testing symptom management strategies, and evaluating telemedicine or care-delivery models. For this tier, near-term impact on patient care is a major consideration, meaning the program expects the work to be positioned to produce actionable improvements in how care is delivered or how patients are supported in the relatively immediate future.
From an administrative standpoint, the opportunity is categorized as discretionary funding and uses grant and/or cooperative agreement mechanisms. It is listed under CFDA 12.420 and is open to an unrestricted range of applicants (meaning any entity type may apply, subject to any eligibility clarifications in the full text). The FY23 posting was created on February 8, 2023, with an original closing date of July 13, 2023. The listing indicates an expected number of awards of three, and the award ceiling is shown as 0 in the source data, which typically signals that applicants should rely on the detailed announcement for budget limits and tier-specific caps rather than the high-level summary field.Apply for HT9425 23 ALSRP PCTA
- The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DOD Amyotrophic Lateral Sclerosis, Pilot Clinical Trial Award" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
- This funding opportunity was created on Feb 08, 2023.
- Applicants must submit their applications by Jul 13, 2023. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 3 candidate(s).
- Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
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FAQs: DOD Amyotrophic Lateral Sclerosis (ALS) Pilot Clinical Trial Award (FY23 ALSRP PCTA)
What is the FY23 ALSRP Pilot Clinical Trial Award (PCTA)?
The FY23 ALSRP PCTA is a Department of Defense funding opportunity (opportunity number HT9425 23 ALSRP PCTA) administered through the U.S. Army Medical Research Acquisition Activity (USAMRAA). It is designed to speed the launch of early-stage ALS clinical trials that could meaningfully change how ALS is treated or managed.
What is the main goal of this award?
The main goal is to support rapid, well-justified early clinical studies that generate decision-quality evidence to guide next steps in development. The emphasis is on reducing uncertainty and helping the field move faster into larger, more definitive trials, rather than completing an entire development program within the award period.
What clinical trial phases are typically supported?
Projects supported under this award typically fall in the phase 1 to small, early phase 2 range.
What kinds of questions should a supported trial be able to answer?
The program is looking for trials that can answer high-value questions such as whether an intervention is safe enough to continue development, whether the protocol and recruitment approach are feasible in real-world ALS settings, whether proposed biomarkers perform as expected in patients, and whether there is a signal of therapeutic efficacy that justifies a larger follow-on trial.
What does the program mean by "decision-quality evidence"?
In this context, decision-quality evidence means results strong enough to guide clear next steps, such as whether to advance to a larger study, adjust dosing or device parameters, refine endpoints, focus on specific patient subgroups, or validate biomarker approaches.
What types of interventions are eligible for the main clinical trial pathway?
Interventions may include drugs, biologics, or devices. They are expected to be supported by a strong scientific rationale and backed by preliminary clinical experience and/or solid preclinical data.
Is the award intended to bring a therapy to widespread clinical use by the end of the project?
No. The program frames impact as how well the trial results can improve and accelerate future trials, not whether the therapy is ready for widespread clinical use by the end of the project period.
How does the opportunity define "impact"?
Impact is defined in terms of whether trial results can improve and accelerate subsequent research and clinical trials. Examples include validating endpoints, identifying responsive subgroups, establishing dosing or device parameters, demonstrating feasibility across sites, or providing evidence that supports a larger, more definitive study.
Does the program allow trials focused on specific ALS subpopulations?
Yes. The opportunity explicitly recognizes ALS heterogeneity and allows outcomes and designs focused on specific ALS subpopulations. It can also accommodate highly individualized approaches as long as the trial remains clinically meaningful and capable of informing subsequent research or care.
Are genotype- or phenotype-informed trial designs allowed?
Yes. The flexibility described in the announcement can support targeted therapies and genotype- or phenotype-informed approaches, including biomarker-defined cohorts, when a one-size-fits-all trial would be unlikely to be informative.
Are biomarkers an important part of this funding opportunity?
Biomarkers are specifically called out as an area the program wants to evaluate in patients. Proposed trials may aim to determine whether biomarkers perform as expected and whether they can help make trials more informative or efficient.
Does the opportunity include support for studies that are not testing a new therapeutic?
Yes. The announcement includes a separate pathway called the Clinical Care Tier for studies that do not test a novel therapeutic but instead focus on optimizing established ALS clinical care.
What kinds of projects fit the Clinical Care Tier?
The Clinical Care Tier is intended for practical, patient-centered projects such as improving respiratory care strategies, refining or enhancing approved devices and assistive technologies, developing or testing symptom management strategies, and evaluating telemedicine or care-delivery models.
What is the key evaluation emphasis for the Clinical Care Tier?
For the Clinical Care Tier, near-term impact on patient care is a major consideration. The work is expected to be positioned to produce actionable improvements in how care is delivered or how patients are supported in the relatively immediate future.
Are budget limits the same for the main pathway and the Clinical Care Tier?
No. The Clinical Care Tier has a lower allowable total direct cost. The listing also shows an award ceiling of 0 in the source data, which typically indicates applicants should rely on the detailed announcement for budget limits and any tier-specific caps rather than the high-level summary field.
What funding mechanisms are used for this opportunity?
The opportunity uses grant and/or cooperative agreement mechanisms.
How is this opportunity categorized from a funding standpoint?
It is categorized as discretionary funding.
What is the CFDA number for this opportunity?
The listing is under CFDA 12.420.
Who is eligible to apply?
The opportunity is open to an unrestricted range of applicants, meaning any entity type may apply, subject to any eligibility clarifications in the full announcement text.
Which agency administers this award?
It is a Department of Defense opportunity administered through USAMRAA (U.S. Army Medical Research Acquisition Activity).
When was the FY23 posting created and what was the original closing date?
The FY23 posting was created on February 8, 2023, and the original closing date was July 13, 2023.
How many awards were expected?
The listing indicates an expected number of awards of three.
What does it mean that the award ceiling is shown as 0 in the listing?
An award ceiling shown as 0 in summary source data typically signals that the budget cap is not captured in that high-level field and that applicants should consult the full announcement for the actual budget limits and any tier-specific caps.
What makes a trial a strong fit for this program, based on the description?
A strong fit is an early-stage clinical trial that is rapid and well-justified, designed to reduce uncertainty, and capable of generating evidence that clearly informs next steps. Fit is strengthened when the study can realistically assess safety, feasibility, biomarkers, and early signals of benefit, and when results would directly improve or accelerate later trials or care strategies.
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| DOD Ovarian Cancer, Investigator-Initiated Research Award Apply for HT9425 23 OCRP IIRA Funding Number: HT9425 23 OCRP IIRA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
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