This program announcement must be read in conjunction with the General Application Instructions, version CD26_01.

Program Announcement for the Defense Health Agency

Amyotrophic Lateral Sclerosis Research Program

Pilot Clinical Trial Award

Funding Opportunity Number: HT942526ALSRPPCTA

Pre-Application Due: June 24, 2026

Application Due: September 30, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

Section Shortcuts Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Amyotrophic Lateral Sclerosis Pilot Clinical Trial Award 2

Content

Before You Begin 2

Basic Information Summarizes the funding opportunity, funding details, submission deadlines and review dates

Eligibility Details eligibility factors for the applicant organization and Principal Investigator

Program Description Describes the program mission and intent of the Pilot Clinical Trial Award; provides key award information and considerations; and outlines funding details

Application Contents Presents the two-step application process and instructions for preparing a pre-application and full application

Submission Requirements Provides locations for application packages, instructions for submitting pre-applications and full applications, and describes application verification

Application Review Information Outlines the processes for application compliance review, pre-application and full application selection/notification, and risk assessment. Also, details the review criteria for pre-application screening and both tiers of the CDMRP application review process – Peer Review and Programmatic Review

Federal Award Notices Outlines what a successful applicant can expect if recommended for funding

Post-Award Requirements References policy requirements for funded research; outlines reporting requirements and restrictions related to Principal Investigator changes and institutional award transfers

Other Information Outlines criteria for administrative actions including application rejection, modification, withdrawal and withhold

Appendix 1 Includes a checklist for all full application components to facilitate application submission

Appendix 2 Acronym List

Appendix 3 Change Log

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Before You Begin

• Active SAM.gov, eBRAP.org and Grants.gov registrations are required for application submission. User registration for each of these websites can take several weeks or longer.

Each applicant must ensure their registrations are active and up to date prior to application preparation.

• Read this funding opportunity announcement in the order it is written before beginning to prepare application materials. It is the responsibility of the applicant to determine whether the proposed research meets the intent of this funding opportunity and that all parties meet eligibility requirements.

• To support application preparation, additional resources are available including an application process FAQ, a Guide for Intragovernmental & Intramural Applicants and a CDMRP Video Series detailing the application process.

Who to Contact for Support

This document uses internal links; you can go back to where you were by pressing the Alt + left arrow keys (Windows) or command + left arrow keys (Macintosh) on your keyboard.

Click to be taken to additional guidance and instructions within the General Application Instructions (GAI).

eBRAP Help Desk

301-682-5507 help@eBRAP.org

Questions regarding funding opportunity submission requirements, as well as technical assistance related to pre-application or intramural application submission.

Grants.gov Support Center

800-518-4726 International: 1-606-545-5035 support@grants.gov

Questions regarding Grants.gov registration and Workspace.

https://sam.gov/ https://ebrap.org/eBRAP/public/index.htm https://grants.gov/register https://cdmrp.health.mil/#:~:text=Frequently%20Asked%20Questions%20%C2%BB https://cdmrp.health.mil/#:~:text=Guide%20for%20Intragovernmental%20%26%20Intramural%20Applicants https://ebrap.org/eBRAP/public/Program.htm#:~:text=Journey%20of%20an,Tier%20Review%20Process mailto:help@eBRAP.org mailto:support@grants.gov https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

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1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Amyotrophic Lateral Sclerosis Research Program (ALSRP) Pilot Clinical Trial Award (PCTA) supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of amyotrophic lateral sclerosis (ALS). Projects may range from phase 1 to small-scale phase 2 trials.

Applications must address one of the following focus areas:

• Biomarker-Driven Interventions: Disease-modifying interventions, with mechanism-specific biomarkers to predict which clinical trial participants are likely to respond, demonstrate target engagement, and effects on the intended biological pathway.

• Clinical Care: Improving aspects of clinical care and symptom management for ALS.

Distinctive Features: Funding from this award mechanism must support a clinical trial. The clinical trial should begin no later than 12 months after the award date or 18 months for U.S.

Food and Drug Administration (FDA)-regulated studies.

Projects proposing a therapeutic intervention (drug, biologic, and/or device) must incorporate biomarkers specific to the intervention into the trial design.

All pre-applications and applications are required to incorporate community collaboration, as described in Section 3.2.2, to optimize research impact.

Applications must include a detailed Regulatory Strategy plan that outlines the approach for obtaining regulatory approvals, if required, specifically for the funded portion of the study. In addition, applications must provide a separate Transition Plan that describes how the outcomes of the study will be advanced to the next phase of development, beyond the scope of the funded work.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $5.6 million (M) to fund approximately two Pilot Clinical Trial Award applications with total cost caps of $2.8M per award. The maximum period of performance is three years. It is anticipated that awards made from this FY26 funding opportunity will be funded with FY26 funds, which will expire for use on September 30, 2032. Awards supported with FY26 funds will be made no later than September 30, 2027.

Submission and Review Dates and Times

• Pre-Application (Preproposal) Submission Deadline: 5:00 p.m. Eastern Time (ET), June 24, 2026

• Invitation to Submit an Application: August 3, 2026

• Application Submission Deadline: 11:59 p.m. ET, September 30, 2026

• End of Application Verification Period: 5:00 p.m. ET, October 6, 2026

• Peer Review: November 2026

• Programmatic Review: January 2027

Announcement Type: Modified

Funding Opportunity Number: HT942526ALSRPPCTA

Assistance Listing Number: 12.420

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2. Eligibility Information

2.1. Eligible Applicants

2.1.1. Organization

Extramural and intramural U.S. Department of War (DOW) organizations are eligible to apply, including foreign and domestic organizations, for-profit and nonprofit organizations, and public or private entities.

2.1.2. Principal Investigator

Independent investigators affiliated with an eligible organization are eligible to be named as Principal Investigator (PI) on the application, regardless of ethnicity, nationality or citizenship status. An investigator may be named as PI on no more than three FY26 ALSRP applications across all award mechanisms, in any combination.

2.2. Cost Sharing

Cost sharing is not an eligibility requirement.

2.3. Other

Awards are made to eligible organizations, not to individuals. Refer to the GAI for additional recipient qualification requirements.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Index:~:text=Extramural%20Organization%3A https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=Intramural%20DOW%20Organization%3A%20A%20subset%20of%20intragovernmental%20organizations%3B%20refers%20specifically%20to%20DOW%20organizations%2C%20including%20DOW%20laboratories%2C%20DOW%20military%20treatment%20facilities%2C%20and/or%20DOW%20activities%20embedded%20within%20a%20civilian%20medical%20center.

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3. Program Description

The Defense Health Agency Contracting Activity (DHACA) is soliciting applications to this funding opportunity using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). The CDMRP is the program office managing this FY26 funding opportunity as part of the Amyotrophic Lateral Sclerosis Research Program (ALSRP). The CDMRP is located within the Defense Health Agency Research and Development (DHA R&D), which is a part of the Department of Defense, DOD, herein referred to using the secondary title Department of War, DOW. Congress initiated the ALSRP in 2007 to provide support for research of high potential impact and exceptional scientific merit. Appropriations for the ALSRP from FY07 through FY25 totaled $309.4M. The FY26 appropriation is $40M.

The Vision of the FY26 ALSRP is to improve outcomes and find cures for people with ALS. The Mission is to fund and accelerate research that translates science into effective ALS treatments.

The program will prioritize applications that support the vision and mission of the FY26 ALSRP.

3.1. Award History

The ALSRP Pilot Clinical Award mechanism was first offered in FY22. Since then, 39 Pilot Clinical Trial Award applications were received, and 11 were recommended for funding.

3.2. Intent of the Pilot Clinical Trial Award

The FY26 ALSRP Pilot Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or symptom management of ALS. Proposed research projects must include clinical trials that address more than just safety of the intervention. Projects should also be designed to assess therapeutic efficacy, biological effects, and/or clinical outcomes, and may range from phase 1 to small-scale phase 2 trials.

Projects proposing a therapeutic intervention (drug, biologic, and/or device) must incorporate mechanism-specific biomarkers directly relevant to the intervention into the trial design. 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 12, 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.

3.2.1. Focus Areas for the PCTA

To meet the intent of the funding opportunity, applications to the FY26 ALSRP Pilot Clinical Trial Award must address one of the following focus areas. Applicants will be required to select either the Biomarker-Driven Interventions or the Clinical Care focus area:

Biomarker-Driven Interventions: Disease-modifying interventions, with mechanism-specific predictive and/or mechanism-specific pharmacodynamic biomarkers. Biomarker Driven Intervention trials should aim to de-risk and inform the design of more advanced trials by investigating safety, feasibility, biomarker application, and therapeutic efficacy in relevant patient populations. Clinical trials may be designed to evaluate promising drugs, biologics, or devices with anticipated therapeutic impact that are supported by strong scientific rationale and existing preliminary studies and/or preclinical data.

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Clinical Care: Improving aspects of clinical care and symptom management for ALS. Clinical Care focus area trials should aim to improve aspects of patient care and ALS symptom management.

3.2.2. Key Elements for the PCTA

• Impact:

○ Biomarker-Driven Interventions: The impact of these pilot clinical trials is not measured by how close the therapy is to approval at the end of the proposed work. Instead, it is based on whether the outcomes significantly de-risk and inform the design of future later-phase trials for the intervention under investigation. The potential impact may be global or limited to specific subpopulations of ALS patients or even individual patients.

○ Clinical Care: Trials designed to improve aspects of ALS clinical care and/or symptom management should have near-term impact on people living with ALS.

○ Future Efforts: Applications must clearly explain how the data generated from the proposed effort will inform the design of future trials or clinical care, and outline how the data will be utilized.

• Employing Community Collaborations to Optimize Research Impact Is Required.

Research funded by the FY26 ALSRP PCTA should be responsive to the needs of people with ALS, their families, and/or their care partners. Research teams are therefore required to establish and utilize effective and equitable collaborations and partnerships with community members to maximize impact potential of the proposed research. These collaborations are expected to facilitate accessible, efficient, and humane clinical trials. Pre-applications and applications to the FY26 ALSRP PCTA must incorporate a community collaboration to provide advice and consultation throughout the planning and implementation of the research project.

The Community Collaboration partners should have meaningful and ongoing input on all aspects of the project, which can include needs assessment, planning, research intervention design, implementation, evaluation, and dissemination. Interactions with other team members should be well integrated and ongoing, not limited to attending seminars and semi-annual meetings. Examples of community collaborations include:

○ Person(s) Living With ALS, Family Member(s) and/or Care Partners(s): The research team includes persons with ALS, their family members, or care partner (past or present) as a project advisor who will provide advice and consultation throughout the planning and implementation of the research project.

○ Partnership With a Community-Based Organization: The research team establishes a partnership with at least one community-based organization that provides advice and consultation throughout the planning and implementation of the research project.

Community-based organizations may include advocacy groups, service providers, policymakers, or other formal organizational stakeholders. Conflicts of interest should be avoided.

○ Community Advisory Board: A community advisory board is composed of multiple community stakeholders and can take many forms, from a board of people living with ALS, their family members, or care partners to a coalition of community-based organizations, or any combination thereof. As with people living with ALS and organizational partners, the community advisory board provides advice and consultation throughout planning and implementation of the research project.

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FY26 Amyotrophic Lateral Sclerosis Pilot Clinical Trial Award 8

When developing applications for the ALSRP PCTA mechanism, the ALSRP strongly encourages applicants to provide sufficient evidence to demonstrate the following key considerations:

• Availability of, and access to, the study population.

• Intervention access and availability.

• Study team composition appropriate for the proposed research.

• Statistical considerations, data management and analysis plans appropriate for the proposed research.

3.2.3. Other Important Considerations for the PCTA

The ALSRP aims to improve the health, care, and well-being of military Service Members, Veterans, their families, and the American public affected by ALS. Scientific research indicates a relationship between ALS and military service, showing a higher incidence of ALS among Veterans. However, the reasons for this increased incidence remain unknown. Knowledge, information, products, or technologies gained from the proposed research should advance research that is of significance to Service Members, Veterans and/or their Families.

Funding from this award mechanism must support a clinical trial. Preclinical research is not supported in this funding opportunity.

Applicants seeking funding for research that does not meet the definition of a clinical trial should consider other FY26 ALSRP funding opportunities that may be more appropriate for such research.

An informational resource for preparing an application, the Human Subject Research Resource, is available on the CDMRP website.

The proposed clinical trial is expected to begin no later than 12 months after the award date or 18 months after the award date for studies regulated by a regulatory agency. Unless otherwise noted, for the purposes of this funding opportunity, regulatory agency refers to the U.S. Food and Drug Administration (FDA) or any equivalent international regulatory agency.

If an Investigational New Drug (IND) application, Investigational Device Exemption (IDE), or equivalent, is required, a regulatory application must be submitted to the relevant regulatory agency by the Pilot Clinical Trial Award application submission deadline. The regulatory application should be specific to the product and indication to be tested in the proposed clinical trial.

All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of clinical and preclinical research, such as those described in the STROBE, CONSORT, SPIRIT and ARRIVE 2.0 guidelines.

Applications from investigators within the DOW and applications involving multidisciplinary collaborations among academia, industry, the DOW, the U.S. Department of Veterans Affairs (VA) and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, their Families and the American Public. If the proposed research relies on access to unique resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://cdmrp.health.mil/#:~:text=Human%20Subject%20Research%20Resource https://www.strobe-statement.org/ https://www.nature.com/articles/s41591-025-03635-5#:~:text=SPIRIT%20and%20CONSORT%20are%20evidence,relevant%20empirical%20evidence%20where%20possible https://www.nature.com/articles/s41591-025-03668-w?fromPaywallRec=false https://arriveguidelines.org/arrive-guidelines

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3.3. Funding Instrument

The funding instrument for awards made under the program announcement will be grants

(31 USC 6304).

3.4. Funding Details

Period of Performance: The maximum period of performance is three years.

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $2.8M. If indirect cost rates have been negotiated, indirect costs are to be budgeted in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

All direct and indirect costs of any subaward or contract must be included in the direct costs of the primary award.

The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum three years.

The appropriateness of the budget for the proposed research will be assessed during peer review.

Direct Cost Restrictions: For this award mechanism, direct costs:

May be requested for (not all-inclusive):

• Travel in support of multi-institutional collaborations.

• Costs for one investigator to travel to two scientific/technical meetings per year. The intent of travel to scientific/technical meetings should be to present project information or disseminate project results from the ALSRP Pilot Clinical Trial Award.

• Research subject compensation and reimbursement for trial-related out-of-pocket costs (e.g., travel, lodging, parking, costs associated with caregiving, and resources/equipment to enable participation).

Must not be requested for:

• Costs for travel to scientific/technical meeting(s) beyond the limits stated above.

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4. Application Contents and Format

4.1. Application Overview

Application submission is a two-step process requiring both a pre-application submitted via the Electronic Biomedical Research Application Portal (eBRAP) and a full application submitted through eBRAP or Grants.gov. Depending on the submission portal, certain aspects of the application will differ.

Intramural DOW organizations submitting a full application should follow instructions for submission through eBRAP.

Extramural organizations submitting a full application must follow instructions for submission through Grants.gov.

4.2. Pre-Application Components

Pre-application submissions must include the following components.

Upload documents as individual PDF files unless otherwise noted. Files must comply with the formatting guidelines listed in the GAI.

• Preproposal Narrative (three-page limit): The Preproposal Narrative page limit applies to text and non-text elements (e.g., figures, tables, graphs, photographs, diagrams, chemical structures, drawings) used to describe the project. Inclusion of URLs that provide additional information to expand the Preproposal Narrative and could confer an unfair competitive advantage is prohibited and may result in administrative withdrawal of the pre-application.

The Preproposal Narrative should include the following:

○ Rationale: Describe in detail the scientific rationale for the study. Provide a brief literature review and analysis. Describe the preliminary studies and/or preclinical data that led to the development of the proposed clinical trial.

○ Clinical Trial: Describe the clinical intervention and phase of clinical trial proposed.

Applications submitted under the Clinical Care focus area must describe a clinical trial to improve aspects of clinical care and symptom management. All applicants must describe a plan for project readiness by the application deadline with respect to availability of and access to clinical reagents and experimental therapeutics that meet regulatory compliance guidelines, availability of and access to appropriate subject population(s), and submission of an IND or IDE application to the FDA, if applicable.

○ Impact in the Intended Population: Describe how the outcomes of the therapeutic approach will de-risk, improve, and accelerate the design of anticipated later phase trials of the intervention under investigation (Biomarker-Driven Intervention focus area) or will improve aspects of ALS clinical care and symptom management (Clinical Care focus area). Describe how the intervention itself offers significant potential impact for individuals affected by ALS. Projects may have outcomes that focus on specific subpopulations of ALS patients. Identify the community collaboration partner(s) and describe how the proposed research question or study design was informed by the ALS community collaborator(s).

○ Use of Biomarkers: For investigation of novel therapeutic approaches, describe the use of predictive, and/or pharmacodynamic biomarkers to improve trial design, patient https://ebrap.org/eBRAP/public/index.htm https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#Appendix2:~:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_Grants:~:text=IV.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20GRANTS.GOV https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_eBRAP:~:text=V.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20eBRAP

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FY26 Amyotrophic Lateral Sclerosis Pilot Clinical Trial Award 11 selection, efficiency, and interpretation. Not required for applications submitted to the Clinical Care focus area.

• Pre-Application Supporting Documentation: The items to be included as supporting documentation for the pre-application must be uploaded as individual files and are limited to the following:

○ References Cited (one-page limit): List the references cited (including URLs if available) in the Preproposal Narrative using a standard reference format that includes the full citation (i.e., author[s], year published, reference title, and reference source, including volume, chapter, page numbers, and publisher, as appropriate).

○ List of Abbreviations, Acronyms and Symbols: Provide a list of abbreviations, acronyms, and symbols used in the Preproposal Narrative.

○ Key Personnel Biographical Sketches: All biographical sketches should be uploaded as a single combined file. Biographical sketches should be used to demonstrate background and expertise through education, positions, publications, and previous work accomplished.

4.3. Full Application Components

Applicants must receive an invitation to submit a full application. Uninvited full application submissions will be rejected.

Each application submission must include the completed full application package for this program announcement. See Appendix 1 for a checklist of the full application components.

(a) SF424 Research & Related Application for Federal Assistance Form (Grants.gov submissions only):

IMPORTANT: When completing the SF424 R&R, enter the eBRAP log number assigned during pre-application submission into Block 4a – Federal Identifier.

(b) Attachments:

Each attachment of the full application components must be uploaded as an individual file in the format specified and in accordance with the formatting guidelines in the GAI.

○ Attachment 1: Project Narrative (15-page limit): Upload as “ProjectNarrative.pdf”.

Describe the proposed project in detail using the outline below. It should be evident that the proposed study meets the definition of a clinical trial.

– Background: Describe in detail the scientific rationale for the study. Provide a review and analysis of the available literature and completed/ongoing studies relevant to the proposed clinical trial.

▪ Describe the preliminary studies and/or preclinical data that support the proposed clinical trial. If preliminary data are provided, the details should be clearly described with statistics.

▪ Summarize key preclinical pharmacological findings, dosage studies and other clinical studies (if applicable) that examine the safety and stability (as appropriate) of the intervention.

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▪ Provide a summary of other relevant ongoing, planned or completed clinical trials, and describe how the proposed study differs.

If the proposed clinical trial was initiated using other funding prior to this application, explain the history and background of the clinical trial and declare the source(s) of prior funding. Identify the specific portions of the study that will be supported with funds from this award.

– Intervention: Identify the intervention to be tested. Include the following components, as applicable: intervention type (drug, device, behavioral, surgical, etc.), complete name and composition, source, general concept of design, administration route. Indicate who holds the intellectual property rights to the intervention, if applicable, and how the PI has obtained access to those rights, along with access to the intervention itself, for conduct of the clinical trial. As applicable, appropriate letters of commitment should be provided in Attachment 2, Supporting Documentation, demonstrating the study team’s access to the intervention(s) for the duration of the clinical trial. Describe how the intervention addresses current clinical needs and how it compares with currently available interventions and/or standards of care.

– Objectives, Specific Aims and Hypotheses: Describe the purpose of the proposed study with detailed objectives. State the hypothesis/research question to be tested in the proposed clinical trial, and detail the specific aims that will address the hypothesis/research question.

– Study Design: Describe the proposed clinical trial in sufficient detail to evaluate its appropriateness and feasibility, relating to both the scientific success of the study and setting reasonable expectations of what study participants will experience.

Consult appropriate guidelines to ensure relevant aspects of rigorous and reproducible research are adequately planned for and, ultimately, reported.

▪ Describe the type of study to be performed. Outline the proposed clinical trial methodology and study variables in sufficient detail to demonstrate a clear course of action and justification. Describe the interaction with the human subject, including the study intervention that they will experience, and include the dose and administration route. Provide sufficient detail in chronological order for a person not involved in the study to understand what the study participant will experience.

▪ Provide a schedule (e.g., flowchart or diagram) of study intervention(s), evaluation(s), and follow-up procedures, including, if applicable, the biospecimen that will be collected, the collection schedule and amount. Describe measures to ensure consistency of dosing (e.g., active ingredients for nutritional supplements, rehabilitation interventions). Define each arm/study group of the proposed trial, if applicable, and describe how group assignment will occur. Include a description of controls, as appropriate. Specify the approximate number of study participants to be enrolled. Indicate whether subjects, clinicians, data analysts, and/or others will be blinded during the study. Describe any other measures to be taken to reduce bias.

▪ Define all endpoints/outcome measures relevant to the objectives of the study;

explain why they were chosen; and describe how, when and where they will be measured. Include all evaluations that will be made for study purposes. If questionnaires or other research data collection instruments will be used, include

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FY26 Amyotrophic Lateral Sclerosis Pilot Clinical Trial Award 13 a copy of them in Attachment 2, Supporting Documentation. Describe the reliability and validity of the selected endpoints/outcome measures and evaluations, along with the applicable quality standards. Explain how the results of evaluations and/or data collection instruments will be used to meet the objectives of the study (or to monitor safety of human subjects).

▪ Briefly describe the study population and the inclusion and exclusion criteria that will be used to meet the needs of the proposed clinical trial. Additional details should be provided in Attachment 6, Study Population Recruitment and Safety Plan.

▪ Applications involving artificial intelligence should include details regarding the specific platforms and approaches they intend to implement.

– Statistical Plan and Data Analysis: Describe the statistical model and data analysis plan with respect to the study objectives. Ensure sufficient information is provided to allow for a thorough evaluation of statistical calculations during review of the application. A Biostatistician may be recruited to peer review the application.

▪ Include a complete power analysis to demonstrate that the proposed clinical trial’s anticipated sample size is appropriate to meet the objectives of the study.

Describe all clinical and statistical justifications and assumptions that support the sample size calculations. Explain any anticipated subgroup analyses and demonstrate that such analyses will be appropriately powered.

▪ Describe the strategy for how sex will be considered as a biological variable. This strategy should include a brief discussion of what is currently known regarding sex differences in the applicable research area. Clearly articulate how sex as a biological variable will be factored into the data analysis plan and how data will be collected and disaggregated by sex. Refer to the CDMRP Directive on Sex as a Biological Variable in Research for additional information.

– Pitfalls and Mitigation Strategy: Describe potential challenges and discuss alternative methods/approaches that may be employed to overcome them.

○ Attachment 2: Supporting Documentation: Combine and upload as a single file named “Support.pdf”.

There are no page limits for these components unless otherwise noted. Include only components described below; inclusion of items not requested or viewed as an extension of the Project Narrative will result in the removal of those items or may result in administrative withdrawal of the application.

References Cited: List the references cited in the Project Narrative using a standard reference format (include URLs, if available).

List of Abbreviations, Acronyms and Symbols: Provide a list of abbreviations, acronyms and symbols.

Facilities, Existing Equipment and Other Resources: Describe the facilities and equipment available for performance of the proposed project; include any additional facilities or equipment proposed for acquisition at no cost to the award. Indicate whether government-furnished facilities or equipment are proposed for use. If so, reference the original or present government award under which the facilities or equipment items are now accountable. There is not a standardized form for this information.

https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Amyotrophic Lateral Sclerosis Pilot Clinical Trial Award 14

Publications and/or Patents: Include a list of relevant publication URLs and/or patent abstracts. If articles are not publicly available, then copies of up to five published manuscripts may be included in Attachment 2. Extra items will not be reviewed.

Letters of Support (two-page limit per letter is recommended): Provide individual letters signed by collaborating individuals and/or organizational officials demonstrating that the PI has the support and resources necessary for the proposed work for the duration of the proposed clinical trial. Letters from the PI’s Department Chair, or appropriate organization official, should also confirm that the PI(s) meet eligibility criteria. If applicable, provide a letter of support, signed by the lowest-ranking person with approval authority, confirming participation of intramural DOW collaborator(s) and/or access to military populations, databases or DOW resources.

If applicable, provide a letter of support signed by the VA Facility Director(s), or an individual designated by the VA Facility Director(s), confirming access to VA patients, resources and/or VA research space.

Research Sharing Plan: Describe the type of data or research resources (e.g., bio-specimen, analysis tool/software, training material) to be made publicly available as a result of the proposed work. Describe the mechanism (e.g., direct sharing, repository, mixed mode) by which data and resources generated during the period of performance will be shared with the research community and other affected communities, including clinical trial participants. Include the name of the repository(ies) where scientific data and resources arising from the proposed clinical trial will be archived, if applicable. Identify and provide the rationale for any data or resources that will not be shared (e.g. for intellectual property, feasibility, cost, or other considerations). The plan should also protect participant privacy, confidential and proprietary data, and performer/third-party intellectual property. Provide a milestone plan for disseminating data/results including when data and resources will be made available to other users. In cases where the study participant could potentially derive medical or other benefit from the information, explain whether the results of screening and/or study participation will be shared with the participant or their primary care provider, including results from any screening or diagnostic tests performed as part of the study.

Do not submit a copy of the National Institutes of Health (NIH) Data Management and Sharing Plan or duplicate the Data Management Plan, which will be requested only after a recommendation for funding is made.

Refer to the CDMRP Directive on Sharing Data and Research Resources for more information about the CDMRP’s expectations for making data and research resources publicly available.

Questionnaires and Other Research Data Collection Instruments: Include a copy of the most recent version of questionnaires, data collection forms, rating scales, interview guides or other instruments. This should include any drafts that are currently in use or underdevelopment. For each instrument, describe how the information collected is related to the objectives of the study. Describe how and when the instrument(s) will be administered. Describe how the instrument(s) will be adapted to the subject population, if applicable.

https://ebrap.org/eBRAP/public/Program.htm#:~:text=Directive%20on%20Sharing%20Data%20and%20Research%20Resources

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Amyotrophic Lateral Sclerosis Pilot Clinical Trial Award 15

○ Attachment 3: Technical Abstract (one-page limit): Upload as “TechAbs.pdf”.

Write the technical abstract using the outline below. Clarity and completeness within the space limits are highly important.

Background: Present the scientific rationale behind the proposed research project.

Clearly define the goals of the effort/study.

Hypothesis/Objective(s): State the objective of the proposed clinical trial and the hypothesis/research question to be addressed.

Specific Aims: State the specific aims of the study.

Study Design: Briefly describe the study design, including appropriate controls.

Clinical Impact: Briefly describe how the proposed clinical trial will have a significant impact on the research field and/or treatment or management of ALS.

Relevance to Military Health: Briefly describe how the proposed research is relevant to Service Members, Veterans and their Families.

○ Attachment 4: Lay Abstract (one-page limit): Upload as “LayAbs.pdf”.

The lay abstract should address the points outlined below in a manner that is readily understood by readers without a background in science or medicine. Avoid overuse of scientific jargon, acronyms and abbreviations. Do not duplicate the technical abstract.

Summarize the objectives and rationale for the proposed research.

Describe the intervention(s).

What ALS population will the research help, and how will it help them?

What are the potential clinical applications and potential risks of the anticipated outcomes?

Describe the ultimate applicability and impact of the proposed study and the anticipated outcomes to advancing ALS research, patient care and/or quality of life.

Describe the potential benefit of the proposed study and the anticipated outcomes to Service Members, Veterans and/or their Families.

○ Attachment 5: Statement of Work (six-page limit): Upload as “SOW.pdf”.

Refer to eBRAP for the Suggested SOW Format.

For guidance on preparing the SOW, refer to the Example: Assembling a Clinical Research and/or Clinical Trial Statement of Work. Include milestones for data or research resource(s) sharing.

○ Attachment 6: Study Population Recruitment and Safety Plan (no page limit):

Upload as “StudyPopPlan.pdf”. Include the components listed below. A bioethicist may be recruited to peer review the application.

Enrollment Distribution: Provide anticipated enrollment table(s) with the proposed enrollment distributed on the basis of sex, race, and ethnicity using the Public Health Service (PHS) Inclusion Enrollment Report. The enrollment table(s) should be appropriate to the objectives of the study.

Inclusion/Exclusion Criteria: List the inclusion and exclusion criteria for the proposed clinical trial. If limiting inclusion by age, race, ethnicity or sex, provide https://ebrap.org/eBRAP/public/Program.htm#:~:text=Suggested%20SOW%20Format https://ebrap.org/eBRAP/public/Program.htm#:~:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:~:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:~:text=n/a-,Public%20Health%20Service%20Inclusion%20Enrollment%20Report https://ebrap.org/eBRAP/public/Program.htm#:~:text=n/a-,Public%20Health%20Service%20Inclusion%20Enrollment%20Report https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=%C2%B7-,Statement%20of%20Work%3A,-Attach%20as%20%E2%80%9CSOW https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Technical%20Abstract%3A,-Attach%20as%20%E2%80%9CTechAbs https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Lay%20Abstract%3A,-Attach%20as%20%E2%80%9CLayAbs

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Amyotrophic Lateral Sclerosis Pilot Clinical Trial Award 16 strong rationale based on justification from scientific literature, preliminary data or other relevant considerations. List and describe any evaluations (e.g., laboratory procedures, history or physical examination) that are required to determine eligibility/suitability for study participation and the diagnostic criteria for entry.

Describe how the study population represents the population anticipated to benefit from the intervention.

Study Population Availability: Demonstrate that the research team has access to the proposed study population at each site. Describe the approximate number, pertinent demographic information and other relevant characteristics of the study population at each enrollment site. Indicate whether the actual size of available study population may be affected by ongoing clinical trials that compete for the same population. If the proposed research involves access to military and/or VA patient populations and/or DOW or VA resources or databases, describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Also include a plan for obtaining any required data sharing, memorandum of understanding, or other agreements required to access and publish data. Refer to the GAI, Appendix 4, for additional considerations.

Recruitment and Retention Process: Explain methods for identification of potential study participants (e.g., medical record review, obtaining sampling lists, health care provider identification). Describe the recruitment process in detail; address who will identify potential study participants, who will recruit them, and what methods will be used to recruit them. Describe any special care (e.g., personal care assistance, transportation due to side effects of study intervention impairing ability to drive) or equipment (e.g., thermometers, telemedicine equipment) needed for human subjects enrolled in the study. If study participants will be compensated, include a detailed description of and justification for the compensation plan. Describe the methods that will be employed to retain participants within the study. Discuss past efforts in recruiting and retaining study participants for previous clinical trials (if applicable).

Address any potential barriers to accrual and plans for addressing unanticipated delays, including a mitigation plan for slow or low enrollment or poor retention.

Estimate the potential for participant loss to follow-up and how such loss will be handled/mitigated. Indicate whether the study team has considered barriers to clinical trial participation and, if applicable, how the team aims to mitigate or overcome these barriers.

Women and Minorities Recruitment/Retention Strategy: Describe the strategy for recruitment, enrollment and retention specific to women and minorities in the clinical trial appropriate to the objectives of the study.

Informed Consent Process: Specifically describe the plan for obtaining informed consent from study participants; include information regarding the timing and location of the consent process. If minors or other populations that cannot provide informed consent are included in the proposed clinical trial, describe the plan to obtain assent (agreement) from those with capacity to provide it, or a justification for a waiver of assent. Appendix 6 of the GAI contains additional considerations unique to DOW-sponsored research.

Risks/Benefits Assessment:

▪ Foreseeable risks: Clearly identify all study risks, including potential safety concerns and adverse events. Address special precautions to be taken by the human subjects before, during, and after the study (e.g., medication washout…