DoD Grant Pre-Proposals: The Critical First Step

DoD Grant Pre-Proposals:

The Critical First Step

DoD Grant Preproposals:

The Critical First Step

Alan Peterson, PhD, Lt Col, USAF (ret)Aaron and Bobbie Elliott Krus Endowed Chair in Psychiatry

Department of Psychiatry, School of MedicineAssociate Director of Research, Military Health Institute

&

Stacey Young-McCaughan, RN, PhD, COL, USA (ret)

Professor, Department of Psychiatry

School of Medicine

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Overview

• Review of Department of Defense (DoD) research

grant preproposal preparation and submission

• Will help decipher/translate/define DoD acronyms

• How to find Program Announcements and Broad

Agency Announcements

• Review of sample preproposal application

• Unique DoD requirements

• How to partner with military collaborators

• Keys to success

• Ample time for Questions and Discussion

Brief Bio, Alan Peterson, PhD

• Retired USAF Clinical Health Psychologist

• Former Chair, Department of Psychology, Wilford

Hall Medical Center

• Conducted numerous applied clinical research

projects while on active-duty• DoD and NIH funding

• Retired from active duty and started at UT Health

Science Center in December 2005

• Director of STRONG STAR Consortium and

Consortium to Alleviated PTSD

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Brief Bio, Stacey Young-McCaughan, PhD

• Retired U.S Army Colonel & Army Nurse

• Former Chief, Dept of Clinical Investigation at BAMC

• Served as an Intergovernmental Personnel Act (IPA)

consultant to BAMC assisting with regulatory reviews.

• Former Deputy Director, USAMRMC CDMRP

• Former Consultant to the Army Surgeon General for

Nursing Research

• While on active duty, successfully obtained external

research funding (4 DoD & TriService Nursing Research

Program grants)

• Retired from Army and joined UTHSCSA in 2008

• Director of Research for STRONG STAR and CAP

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CDMRP Funding Announcementshttp://cdmrp.army.mil/funding/dmrdp.shtml

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http://cdmrp.army.mil/funding/dmrdp.shtml

Synopsis of FY16-17 Award Mechanisms

• Synopsis of Current Program Announcements

• Amyotrophic Lateral Sclerosis

• Bone Marrow Failure

• Breast Cancer

• Defense Medical Research and Development

Program

• Lung Cancer

• Ovarian Cancer

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Synopsis of FY16-17 Award Mechanisms

• Synopsis of Current Program Announcements

• Amyotrophic Lateral Sclerosis

• Bone Marrow Failure

• Breast Cancer

• Defense Medical Research and

Development Program (DMRDP)

• Lung Cancer

• Ovarian Cancer

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DMRDP Joint Program Committees

(JPCs)

• JPC-1: Medical Simulation & Information

Sciences

• JPC-2: Military Infectious Diseases

• JPC-5: Military Operational Medicine

• JPC-6: Combat Casualty Care

• JPC-7: Radiation Health Effects

• JPC-8: Clinical & Rehabilitative Medicine

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Synopsis of FY16-17 DMRDP Awards

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Sample Program Announcement

Department of Defense

Defense Health Program

Congressionally Directed Medical Research Programs

Defense Medical Research and Development Program

Joint Program Committee-2/

Military Infectious Diseases Research Program

Clinical Study Award

Funding Opportunity Number: W81XWH-17-DMRDP-MID-CSA

Catalog of Federal Domestic Assistance Number: 12.420

Military Medical Research and Development

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Submission & Review Dates & Times

• Pre-Application Deadline:• 5:00 p.m. Eastern time (ET), January 26, 2016

• Invitation to Submit an Application:• March 7, 2016

• Application Submission Deadline:• 11:59 p.m. ET, May 9, 2016

• End of Application Verification Period:• 5:00 p.m. ET, May 12, 2016

• Peer Review: July 2016

• Programmatic Review: August 2016

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Two Documents

• The Program Announcement is one of two

documents with instructions to prepare and

submit an application for this funding opportunity

• The second document, the General Application

Instructions, is available for downloading from

Grants.gov.

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Award Information• The FY17 JPC-2/MIDRP CSA is intended to

support military relevant early phase clinical trials

and in vitro diagnostic medical device clinical

investigations with the potential to have a major

impact on the prevention, screening, diagnosis,

and/or treatment of combat-related or trauma-

induced wound infections.

• Funding from this Program Announcement must

support a clinical trial or medical device testing

and may not be used for preclinical research

studies19

Partnering PI Option• A Partnering PI Option structured to

accommodate up to three PIs who will each

receive a separate award

• One partner is identified as the Initiating PI

• Others as the Partnering PI(s)

• All partners should collaborate in the

development and submission of the proposed

research project.

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DoD Collaboration and Alignment

Encouraged

• Relevance to the health care needs of the military

Service Members, Veterans, and/or other Military

Health System beneficiaries is a key feature of

this award

• Therefore, PIs are strongly encouraged to

collaborate, integrate, and/or align their research

projects with DoD and/or Department of Veterans

Affairs (VA) research laboratories and programs

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Use of Military and VA Populations

or Resources

• If the proposed research plan involves access to

military and/or VA population(s) and/or

resource(s), the PI is responsible for establishing

access

• If possible, access to target military and/or VA

population(s) and/or resource(s) should be

confirmed at the time of application submission

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Use of Military and VA Populations

or Resources

• A letter of support, signed by the lowest ranking

person with approval authority, should be

included for studies involving military Service

members, Veterans, military- and/or VA-

controlled study materials and military and/or VA

databases.

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Funding

• Applications submitted with a single PI or under

the Partnering PI Option have the same funding

limits

• The maximum period of performance is 3

years.

• The anticipated total costs budgeted for the

entire period of performance will not exceed

$2.5 million.

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Tabs 1 & 2 Application Information

• electronic Biomedical Research Application

Portal (eBRAP)

• Contact information for PI

• UTHSCSA Business Official

• Alternate submitted

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Tabs 3: Collaborators and Key

Personnel

• Enter the name, organization, and role of all

collaborators and key personnel associated with

the application

• Important: You cannot add new collaborators

and key personnel after the submission of the

preproposal

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Tabs 4: Conflicts of Interest

• List all individuals other than collaborators and

key personnel who may have a COI in the review

of the pre-application or application

• Include those with whom the PI(s) has a personal

or professional relationship

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Preproposal Narrative Formatting• Three-page limit

• Font Size: 12 point, not condensed.

• Font Type: Times New Roman.

• Spacing: Single space or no more than six lines

of type within a vertical inch (2.54 cm).

• Page Size: No larger than 8.5 inches x 11.0

inches (21.59 cm x 27.94 cm).

• Margins: At least 0.5 inch (1.27 cm) in all

directions.

• Headers and Footers: Should not be used. Pre-

existing headers and footers on required forms

are allowed. 28

Preproposal Narrative

• The Preproposal Narrative should include

the following:

• Research Plan

• Personnel

• Impact

• Military Benefit

• Alignment with Focus Areas

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Preproposal Narrative• Research Plan

• State the ideas and reasoning on which the

clinical trial/testing is based. Clearly specify

which type (e.g., drug, device, behavioral) of

clinical trial/testing is being proposed and

indicate the phase of trial and/or class of

device and regulatory status as appropriate.

Concisely state the project’s objectives and

specific aims

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Preproposal Narrative• Personnel

• Briefly state the qualifications of the PI(s) and

key personnel to perform the described research

project.

• Impact

• State explicitly how the proposed work will have

an impact on research and patient care for

combat-related or trauma-induced wound

infection. Describe how the study will accelerate

the movement of promising

treatments/devices/assays into clinical practice. 31

Preproposal Narrative• Military Benefit

• Describe how the proposed work will directly or

indirectly benefit military Service Members, Veterans,

and/or other Military Health System beneficiaries

affected by combat-related or trauma-induced wound

infections.

• Alignment with Focus Areas• Explain how the proposed work addresses at least

one of the FY17 JPC-2/MIDRP CSA Focus Areas:• Therapeutics

• Rapid detection of pathogens and/or anti-microbial drug

resistance markers.

• Rapid detection of biomarkers32

Preproposal Supporting

Documentation

• 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• Author[s]

• Year published

• Title of reference

• Source of reference

• Volume

• Chapter

• Page numbers

• Publisher33


Documentation

• List of Abbreviations, Acronyms, and

Symbols

• Provide a list of abbreviations, acronyms, and

symbols used in the Preproposal Narrative.

• Key Personnel Biographical Sketches

• Five-page limit per individual (DoD format)

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Documentation

• Quad Chart

• Complete the Quad Chart as instructed

• The Quad Chart template and instructions are

available on eBRAP

(https://ebrap.org/eBRAP/public/Program.htm).

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Insert Project Title HereInsert ERMS/Log Number and Task Title Here

Insert Award Number Here

Insert a picture or graphic

here, with a caption, that

represents the proposed

work

PI: Insert PI Name Here Org: Insert Recipient Organization/Contractor Name Here Award Amount: $$$$$$$

Study/Product Aim(s)•••••

Approach

Free text.

Goals/Milestones (Example)CY15 Goal – System demonstration

Functionality tests of integrated firmware and software

CY16 Goals – System validation

Investigate earplug designs based on collected features Complete formal attenuation and comfort trials of earplugsCY17 Goal – Production readiness

Validate design architecture for digital ear canal

volumetric shape capture and data workflowCY18 Goal – Navy suitability testing Field test on aircraft carrier flight deck

Comments/Challenges/Issues/Concerns• If timelines change, comment here. • If off by more than one quarter in spending, comment

here.Budget Expenditure to DateProjected Expenditure:Actual Expenditure:

Updated: (place date of last update)

Timeline and Cost

Activities CY 15 16 17 18

Text (Major aim/study/milestone)

Estimated Budget ($K) $000 $000 $000 $000




Accomplishment: Place a description of the latest scientific accomplishment here. Limit the comments to three lines or less to make them fit; be succinct. These comments are valuable since they show progress.

PI: Daniel J. Taylor, Ph.D. Org: University of North Texas

Study Aims• Determine if treating both PTSD and sleep disturbances (insomnia and nightmares),

with both Cognitive Processing Therapy (CPT) and Cognitive Behavioral Therapy for Insomnia and Nightmares (CBTI&N) results in greater PTSD symptom reduction than CPT only.

• Determine if the sequencing of CPT and CBTI&N results in differential effects on PTSD symptom reduction.

• Determine if selected biomarkers a) predict PTSD and sleep response, b) mediate treatment outcomes, c) respond to treatment.

Approach

Randomized controlled trial of 222 active duty and recently discharged Veterans with PTSD, insomnia, and nightmares comparing three 12-week interventions.

1. CBTI&N+CPT: CBTI&N followed by CPT2. CPT+CBTI&N: CPT followed by CBTI&N

3. CPT: CPT followed by additional CPTThe primary outcome measure will be PTSD severity (CAPS-5 scores) assessed at baseline and post-treatment.

Goals/MilestonesCY15 Goal –Launch Grant

Finalize Interventions

Obtain IRB approval from UTHSCSA, UNT, BAMC, Duke, HRPO

Train and certify therapists not already certified

Purchase equipment

Adapt and finalize data storage system

Begin recruitment, randomization, treatment, & data collection

CY16 Goals – Recruit, randomize, treat, collect and score data

Continue recruitment, randomization, treatment, & data collection

CY17 Goal – Recruit, randomize, treat, collect and score data

Continue recruitment, randomization, treatment, & data collection

CY18 Goal – Recruit, randomize, treat, finalize data, report results

Complete recruitment, treatment, and assessments.

Analyze data and disseminate results

Timeline and Cost


Finalize treatment manuals & train

staff; ensure fidelity to treatment

Obtain initial IRB approvals & maintain

regulatory compliance

Recruit, randomize & treat patients

Finalize data & report results

Est. Budget ($K) VA

DoD

$258

$581

$265

$518

$272

$578

$150

$440

Estimated Award Amount:

VA: $945,287; DoD: $2,116,906; Total: $3,062,193

CBTI&N

CBTI&N

Post-Treatment

Screening & Baseline

Randomization

CPT

CPT 12 W

eeks

3-Month Follow-up

CPT

CPT

Interim Assessment

6-Month Follow-up

Treatment Of Comorbid Sleep Disorders and PTSD

Updated: 29 APRIL 2015

PI: Meghan McDevitt-Murphy, PhD. Org: The University of Memphis

Goals/MilestonesCY 15 Goals

Obtain regulatory approvals

Hire and train staff

Pilot test EMA technology

Initiate data collection using EMA method

CY 16 Goals

Continue to conduct EMA study

Conduct follow up interviews

CY 17 Goals

Complete data collection of EMA sample

Collect follow up interview data

Develop and Pilot test time allocation questionnaire

Data cleaning, data analysis

CY 18 Goals

Data analysis Submit manuscripts based on findings

Timeline and Cost

Estimated Award Amount:

VA: $248,881 ; DoD: $661,757; Total: $910,638

A Behavioral Economic Analysis of PTSD Using Ecological Momentary Assessment

Updated: 29 APRIL 2015


Regulatory approvals & staff training

Study Recruitment

Data collection

Data Cleaning & Dissemination of

Findings

Estimated Budget ($K) VA

DoD

$72

$205

$74

$202

$76

$202

$26

$52

Study Aims1. Utilize EMA data to examine the temporal relations between

activity engagement and PTSD.

2. Create metrics reflecting categories of behavior al activity that

are meaningful to PTSD and may predict disability.

3. Develop a self-report questionnaire to measure these

behaviors.

ApproachConduct a “proof of concept” study using EMA technology to continuously monitor the behavioral activity patterns of combat veterans with PTSD in their natural environments to develop behavioral economic models predicting PTSD symptoms and co-occurring behaviors based on metrics of behavior allocation, broadly defined toward engagement or avoidance.

Preproposal Screening Criteria• To determine the technical merits of the pre-

application and the relevance to the mission of

the DHP and JPC-2/MIDRP, pre-applications will

be screened based on the following criteria:

• Research Plan

• Personnel

• Impact

• Military Benefit


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Preproposal Screening Criteria• Research Plan

• How well the rationale, objectives, and specific

aims support the research idea

• To what degree the proposed project

addresses the intent of the award mechanism

and addresses an important problem relevant

to combat-related or trauma-induced wound

infections

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Preproposal Screening Criteria

• Personnel

• How well the qualifications and expertise of the

PI(s) and key personnel are appropriate to

perform the proposed research project.

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Preproposal Screening Criteria• Impact

• How well the clinical trial/testing addresses an

important problem relevant to combat-related or

trauma-induced wound infection prevention and/or

management, and antimicrobial countermeasures

• If successful, how the outcomes will improve our

capabilities to prevent, screen, diagnose, and/or

treat combat-related or trauma-induced wound

infections

• To what degree the clinical trial/testing will

accelerate the movement of promising

treatments/devices/assays into clinical practice. 42

Preproposal Screening Criteria• Military Benefit

• To what degree the proposed clinical

trial/testing will directly or indirectly benefit

military Service members, Veterans, and/or

other Military Health System beneficiaries

affected by combat-related or trauma-induced

wound infections.


• How well the project addresses at least one of

the FY17 JPC-2/MIDRP CSA Focus Areas.

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How to find Focus Areas?• Go to the Program Announcement

• FY17 JPC-2/MIDRP CSA Focus Areas

• Therapeutics

• Rapid detection of pathogens and/or anti-

microbial drug resistance markers

• Rapid detection of biomarkers

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CDMRP Help Desk• Questions related to Program Announcement

Funding Opportunity content or submission

requirements as well as questions related to the

submission of the pre-application through eBRAP

should be directed to the CDMRP Help Desk,

which is available Monday through Friday from

8:00 a.m. to 5:00 p.m. ET. Response times may

vary depending upon the volume of inquiries.

• Phone: 301-682-5507

• Email: [email protected]

If selected to submit full application,

may have limited time

• Invitation to Submit an Application:• March 7, 2016

• Application Submission Deadline:• 11:59 p.m. ET, May 9, 2016

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Questions and Discussion

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DoD Grant Pre-Proposals: The Critical First Step

Documents

Transcript of DoD Grant Pre-Proposals: The Critical First Step