Medical Images HTML and Clinical Trial Remote Collaboration

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 U S spending on clinical trials was approximately $ billion Over the past decade the efficiency of clinical trials has been improved by electronic data capture EDC systems whose use has increased from to from to While medical imaging plays an important role in clinical trials often serving as the basis for 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 worldandapos s first andquot zero footprintandquot 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 andquot cloud based imaging corelab of the futureandquot that provides support for all imaging corelab activities We propose that by moving imaging corelabs out of their traditional andquot brick and mortarandquot environments and into the andquot cloudandquot medical images can be interpreted from anywhere in the world within minutes rather than weeks Moving corelabs to andquot the cloudandquot 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 the study population thereby reducing the number of patients needed to detect treatment effects trial durations and trial costs 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 andquot cloud based imaging corelab of the futureandquot where medical images can be interpreted from anywhere in the world resulting in reduced patient safety risks shorter trial durations and lower costs