In an effort to save lives and money in the expensive healthcare field, a University of Chicago Booth School of Business professor and a Ph.D. student have devised a way to expedite the trial phase of pharmaceuticals development.
John R Birge, Jerry W and Carol Lee Levin Professor of Operations Management, and Vishal Ahuja, a Ph.D. student, wrote their results in ‘Fully Adaptive Designs for Clinical Trials: Simultaneous Learning from Multiple Patients,’ a working paper that they are revising for publication.
The researchers see a possible way to shorten clinical trials, which have increased in length by 70 per cent from 1995 to 2005, while the cost for a single trial has surged to as much as $100 million. Birge and Ahuja hope to change the status quo which is based on an agrarian model from the 1920s that was used to analyse crop yields to a more responsive method.
Though the research must still move from mathematical model to reality, which would require FDA approval after the paper is published, the researchers, when studying data from a 2008 trial on stents that were used to treat stroke patients, detected the potential of adaptive trials to save time, money and lives over traditional trials.
Birge and Ahuja found that, had the trial used their model, 17 failures could have been prevented. In the traditional study, which involved 451 patients, participants who received the stent were more than twice as likely to have a second stroke or die as those who received conventional treatments. Five people who received the stents died, and 46 trial participants had experienced a stroke or died within 30 days of receiving treatment.
The research currently works best with diseases and treatments when effects reveal themselves quickly, says Elbert Huang, Director of the University of Chicago’s Centre for Translational and Policy Research of Chronic Diseases, and works less well when effects manifest themselves more slowly, as with diabetes.
Birge and Ahuja are working to address that challenge, and are studying doctors who treat diabetes to understand how they determine the best sequences of treatments to offer patients. They are using data from a large, government-funded study that Huang is overseeing, which is investigating what drugs doctors have prescribed for roughly 500,000 diabetes patients treated through the US Department of Veterans Affairs.
EP News Bureau – Mumbai
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