TRANSCENDing the Status Quo
A patient in need of lifesaving treatment today may wait as long as 15 years for a new drug to advance from initial discovery to FDA approval. Researchers at the Helen Diller Family Cancer Center at the University of California, San Francisco and 19 other cancer centers across the United States will use TRANSCEND, a caBIG«-enabled bioinformatics platform, to power new clinical trials methods designed to shorten this timeline and speed the delivery of new therapies to women with advanced breast cancer. Over the next five years, the I-SPY 2 TRIAL is expected to examine as many as twelve promising drug candidates.
New Capabilities Provided by TRANSCEND
The flexible approach employed by I-SPY 2 requires rapid data collection and analysis. To meet this need, UCSF researchers worked with caBIG« and 3rd party software developers to create a comprehensive, scalable bioinformatics infrastructure known as TRANSCEND (TRANslational Informatics System to Coordinate Emerging Biomarkers, Novel Agents, and Clinical Data).
TRANSCEND leverages caBIG« tools and 3rd party open source products, such as an electronic health record (EHR) created by Tolven, which are connected via the caBIG« Integration Hub to achieve uniform data collection across the 20 participating sites and to ensure interoperability and compliance with standard biomedical terminologies such as SNOMED CT.
TRANSCEND also provides capabilities to ensure fast, widespread access to trial data. Traditionally, data are not released to researchers until after a trial concludes. However, authorized scientists will have access to de-identified tissue, image, and clinical data from trial participants within months (and in some cases within days) of the patient's completion of the protocol, via Web-based data integration portals that are supported by caIntegrator2. The USCF team worked closely with caIntegrator2 developers over the past year to ensure this new product could meet the needs of this novel trial.
"The investigators are extremely excited to use some of the enhanced analysis features the NCI has put into caIntegrator2," notes Meg Young, the Informatics Project Manager for TRANSCEND at UCSF.
Ken Buetow, Ph.D., adds, "This trial is one of the earliest real-world examples of a learning approach to healthcare that leverages powerful information technology, and we're very excited to be supporting the team at UCSF in this initiative."
TRANSCEND is now in production and the I-SPY 2 TRIAL has recruited its first patients.
While TRANSCEND was developed specifically for the I-SPY 2 trial, the software infrastructure, by design, can be modified to meet the needs of other trials going forward.
Says Dr. Buetow, "We are just starting to demonstrate the potential of this technology to reengineer the drug discovery process. Not only can the tools developed for USCF be adopted and adapted to power future trials, but caBIG« and other standards-based, interoperable platforms will ensure that the data generated by I-SPY 2 can be mined by other scientists to power future discovery. This is only the beginning."