Medical Images, HTML5, and Clinical Trial Remote Collaboration

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$279,636.00
Award Year:
2013
Program:
STTR
Phase:
Phase I
Contract:
1R42HL117397-01A1
Award Id:
n/a
Agency Tracking Number:
R42HL117397
Solicitation Year:
2013
Solicitation Topic Code:
NHLBI
Solicitation Number:
PAR09-221
Small Business Information
5003 SOUTHPARK DR., SUITE 140, DURHAM, NC, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
194348913
Principal Investigator:
ROBERTJUDD
(919) 668-3539
robert.judd@duke.edu
Business Contact:
ROBERTJUDD
(919) 668-3539
robert.judd@duke.edu
Research Institute:
DUKE UNIVERSITY MEDICAL CENTER

DUKE UNIVERSITY
2200 W Main St., Suite 820
DURHAM, NC, 27705-
() -

Abstract
DESCRIPTION (provided by applicant): Medical drugs and devices are regulated by the U.S. Food and Drug Administration (FDA) based on data from multicenter clinical trials. In 2010, U.S. spending on clinical trials was approximately 25 billion. Over the past decade the efficiency of clinical trials has been improved by electronic data capture (EDC) systems, whose use has increased from 38% to 61% from 2006 to 2011. While medical imaging plays an important role in clinical trials, often serving as the basisfor study end-points and/or safety evaluations, few f any EDC systems integrate imaging corelab workflows such as image quality assurance, site queries, and reporting of end-point analyses. Heart Imaging Technologies (Heart IT) developed the world's firstzero footprint medical image viewer, WebPAX, which displays diagnostic-quality images in a bare bones web browser. Recently, several leading vendors of EDC systems have invited HeartIT to enter into partnerships to integrate WebPAX image uploading and viewing into their EDC products. In this project we propose to create a cloud-based imaging corelab of the future that provides support for all imaging corelab activities. We propose that by moving imaging corelabs out of their traditional brick-and-mortar environments and into the cloud , medical images can be interpreted from anywhere in the world within minutes rather than weeks. Moving corelabs to the cloud will not only improve corelab workflows, but will also improve communication between the corelab and the other clinical trials stakeholders such as the CRO, the data safety and monitoring board (DSMB), the sponsor, and the FDA. In addition, making images available rapidly will enable new trial designs that reduce site-to-site variability of thestudy population, thereby reducing the number of patients needed to detect treatment effects, trial durations, and trial costs. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Medical drugs and devices are regulated by the U.S. Food and Drug Administration (FDA) based on data from multicenter clinical trials. Over the past decade the efficiency of clinical trials has been improved by electronic data capture (EDC) systems. While medical imaging plays an important role in clinical trials, often serving as the basis for study end-points and/or safety evaluations, few if any EDC systems integrate imaging corelab workflows. We propose to create a cloud-based imaging corelab of the future , where medical images can be interpreted from anywhere in theworld, resulting in reduced patient safety risks, shorter trial durations, and lower costs.

* information listed above is at the time of submission.

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