Novartis Tapping EDC to Reduce Research Errors, Trim Costs

Widespread use of electronic data capture (EDC) technology is helping Novartis Pharmaceuticals cut down on errors during the clinical trial process and achieve research savings approaching $100 million annually.

Presenting data at Clinical Trials Congress in Philadelphia, biostatistical expert Sylva Collins said Novartis has used EDC to rapidly collect and assess data in 400 trials involving 130,000 patients.

Since eschewing paper records and going nearly 100-percent EDC with its trials since the end of 2003, Novartis has been able to reduce erroneous data by nearly 93 percent, said Collins, Novartis' global head of advanced clinical systems. Data queries with errors have been reduced from 51 per 1,000 data points to 3.7 per 1,000, said Collins.

Collins credits EDC for saving Novartis nearly $100 million in 2003. The median time it takes to lock data with EDC is four days, where back in the days of using paper, it was 10 weeks, she noted. Nearly all of Novartis' new Phase II and Phase III clinical trials use EDC, and more than 60 percent of Phase I trials and some postmarketing trials incorporate EDC features as well.