Development of a qualification plan for the virtual reality functional capacity assessment tool - short list (vrfcat-SLX) (DDT COA #000004)

Active Cooperative Agreement Awarded Last action

Award ID
U01FD008424
Recipient
Awarding agency
Obligated
$749,908

Award facts

Assistance listing
93.103 Food and Drug Administration Research
Completion date 71% complete
Originally
Funding agency
Center for Drug Evaluation and Research Food and Drug Administration, Department of Health and Human Services
Place of performance
Tucson, AZ 85718, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Nearly 7 million people in the united states are living with alzheimer's disease (ad). As people with ad progress through the stages of this disease, their ability to function independently and carry out activities of daily living (e.g., household chores and personal care) decreases due to cognitive impairment progressing to dementia, leading to increased burden on caregivers and the US healthcare system. However, a psychometrically sound, publicly available measure of cognition-dependent day-to-day functioning for persons with ad has not been recognized by FDA as fit-for-purpose for use in early-stage ad drug development. We propose the preparation and submission of a qualification plan (QP) to support the qualification of the virtual reality functional capacity assessment tool-short list (vrfcat-SLX) as a performance outcome (perfo) measure of cognition-dependent day-to-day functioning in people diagnosed with biomarker-positive, clinical stages 2 and 3 ad. A measure of day-to-day functioning was accepted into the center for drug evaluation and research's (cder's) clinical outcome assessment (COA) qualification program under DDT #000004 on october 12, 2016. The pro consortium's cognition working group selected the vrfcat-SLX as the measure for qualification as IT has has qualitative evidence supporting its content validity. A confirmatory qualitative study is underway in people with biomarker-positive, clinical stages 2 and 3 ad. Next, a quantitative evidence strategy will be prepared, supported by a study protocol and statistical analysis plan (SAP) used to develop a qualification plan (QP). The next step in the qualification process will be submission of the QP to FDA to support qualification of the vrfcat-SLX for use in ad drug development. Our approach includes 4 aims. For aim 1, we will convene an advisory panel of clinicians and patient participants to provide recommendations on study design to increase the feasibility of our proposed strategy and to review the study protocol and other study documents. For aim 2, we will prepare a description of the proposed quantitative evidence generation strategy (including development of a protocol and SAP) designed to assess the vrfcat-SLX's measurement properties. For aim 3, we will develop the QP by compiling the evidence from literature and qualitative data from two cognitive interview studies and using the protocol and SAP to complete the relevant sections of the QP, following FDA's COA QP content outline. Aim 4 will involve compiling and submitting the QP with all necessary appendices and attachments. The goal of this project will be a publicly available perfo measure for assessing cognition-dependent day-to-day functioning in clinical trials for people with biomarker-positive, clinical stage 2 and 3 ad. Qualifying the vrfcat-SLX will fill a critical GAP in the measurement of day-to-day functioning in ad treatment trials.

Transactions

Action Obligated Date
Amendment $0
Amendment $0
Amendment $0
Amendment $110,722
Amendment $110,722
Amendment -$110,722
Amendment -$110,722
Amendment $249,962
Amendment $249,962
Original award $249,984

Subawards

Subrecipient Amount Awarded
Eresearchtechnology, Inc. Clario (ERESEARCHTECHNOLOGY, INC) will support the development of a Qualification Plan for the VRFCAT-SLx that is ready for submission to the FDA COA… $199,372
WCG Clinical, Inc. WCG will support the development of a Qualification Plan for the VRFCAT-SLx that is ready for submission to the FDA COA Qualification Program is detailed below:… $114,726

Quick answers

Who received award U01FD008424?

U01FD008424 was awarded to The Critical Path Institute by FDA Office of Acquisition and Grant Services (Food and Drug Administration) on September 1, 2024.

How much is award U01FD008424 worth?

$749,908 has been obligated on U01FD008424.

Which agency awarded U01FD008424?

FDA Office of Acquisition and Grant Services (Food and Drug Administration) awarded U01FD008424, with funding from Center for Drug Evaluation and Research (Food and Drug Administration).

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