By Allison Proffitt 

 

June 27, 2014 | Twenty percent of Phase II clinical failures from 2008-2010 were because of drug safety issues, making safety not only a concern to the patient, but huge cost driver for drug developers. 

 

In AstraZeneca’s Oncology Innovative Medicines department, researchers watched for safety red flags, but only on static reports on clinical result data. The reports weren’t flexible enough to easily answer specific queries on the data (e.g., asking specific trial population-level questions about suspected drug adverse reactions), so scientists performed ad-hoc analyses as ‘one-off’ efforts by taking paper-based static reports, manually reproducing data values in tools like Microsoft Excel and storing report outputs in presentations created using Microsoft PowerPoint. 

 

It wasn’t a good solution. So AstraZeneca and their partner, Tessella, built a better tool to watch ongoing trials. The solution won the pair a 2014 Bio-IT World Best Practices Award in Clinical & Health IT. 

 

“Real-time Analytics of Clinical Trials (REACT) is an informatics system that provides a suite of interactive visualizations for use by study teams during ongoing clinical trials,” the team wrote in their Best Practices submission. “REACT provides insight at both population and subject-specific levels in areas of safety, drug tolerability, efficacy and clinical data capture, whilst retaining the integrity of trial results and the privacy of subjects.”

 

The strength of the REACT system is in visualization. 

 

“It’s about visual, almost pictorial view of events,” explained Anne Westcott, director of AstraZenceca’s Oncology and Infection Business Delivery Unit. “It’s about the speed, simplicity, of understanding those results. And it’s about collaboration. No trial is run in the exact same way. Trials deviate as we’re going forward.”  

 

The system was built by a team of specialists from various areas of AstraZeneca, and “user stories” were collected from study teams to drive functionality. To ensure that each set of requirements was well-formed, unambiguous, fully-specified and feasible for implementation, a Tessella business analyst with both software development skills and a biomedical informatics background was employed

 

The solution was implemented as a Java Extract, Transform and Load (ETL) engine, an Oracle database, TIBCO Spotfire Automation Services for analysis file creation and a Spotfire Webplayer visualization layer. The Tibco Spotfire suite of software components was used to provide interactive visualizations to a user community, and the Spotfire Webplayer component allows visualizations to be securely hosted to a specific user-group, accessible through a web-browser without the need to download any specialized software.  

 

Four analysis types, each with a set of visualizations, make up the REACT Visualization Modules: Drug Safety, in the REACT Safety module; Drug Tolerability, in the REACT Tolerability module; Drug efficacy in the REACT Oncology module; and Clinical study protocol deviations in the REACT Operational module. 

 

Feedback on the platform has been very positive. At the end of 2013, $1.2M had been invested the REACT system and 120 users have been trained. REACT has actively monitored 1150 clinical trial subjects from 23 clinical trials from 9 drug programs. 

 

Developers started working on REACT in the middle of 2012. The first production version of REACT was completed in early 2013; one further version was released towards the end of 2013; and at least one more major software version is planned for release in 2014. The company is committed to further development: investments of $1.84M and $1.35M are planned for 2014 and 2015, respectively.

 

“Initially we were very much focused on oncology; it’s been more of a therapy area approach [than a geographic rollout],”Westcott said. “Our goals for what we call version 3 is that we could be introducing it across therapy areas.”  

In terms of user support, Westcott said patient safety teams and clinical directors have been very happy with the tool. “The other people we’re working with closely are principle investigators at the research sites, where we have the trials going on,” she said. They are also finding value in REACT. 

 

“There are lots of benefits that come out of REACT that are not just the obvious ones like being able to see the profiles for safety and efficacy. Those are things like rapid communication between different parts of the team. Some of our trials will be carried out over more than one trial site. Because of the visual nature of REACT, it really helps with communication among the principle investigator community as well,” Westcott said. 

 

“The REACT project has demonstrated that effective collaboration between different disciplines can drive production of innovative software,” the entry authors said. “The REACT project drew on experts both from within AstraZeneca and from specialist organizations such as Tessella. We believe that our model of prototype-driven agile development should be adopted for developing solutions to complex problems within the drug-development industry.”