Clinical trial success impacts drug development and economy
The success rate of clinical trials for breast cancer drugs can increase by almost 50% when biological markers are used, according to new research from the University of Toronto Mississauga.
“It’s been increasingly difficult for pharmaceutical companies to bring new drugs to market,” says Jayson Parker, a faculty member in the Department of Biology and medical biotechnology analyst at the University of Toronto. “On average, about 80% of drugs fail at some point in the clinical trial process.”
To determine how often breast cancer drugs were brought to market, the researchers examined clinical trial drug development programs from 1998 to 2012. Included in the study were programs involving advanced and metastatic breast cancer as well as patients who were exposed to taxanes and anthracycline.
“We found that only 14% of drugs that undergo human testing for advanced and metastatic breast cancer are eventually approved,” says Parker. “This is worse than the average for the industry as a whole.”
Parker and colleagues sought to test the hypothesis that, in the era of personalized medicine, biological markers could be used to improve clinical trial success rates and help bring more drugs to market faster. Therefore, the research team examined the clinical trial success rates for breast cancer drugs targeting the HER2 biomarker.
Upon comparison of clinical trials that targeted patients with the HER2 biomarker with trials that did not, the research team found the success rate of drug development increased from 15% to 23%.
Furthermore, the study results showed that using the HER2 biomarker in the design of clinical trials resulted in a cost savings of 27%. Thus, improving the success rate of clinical trials also has an economic impact. “This can means millions of dollars in cost reduction for a clinical trial,” says Parker.
Although these findings may be limited to the HER2 biomarker in breast cancer, Parker says the results are encouraging. “This is the first study that has made a systematic comparison between patients with and without a biomarker,” he says. “It provides us with concrete initial evidence that the use of a biomarker can help improve clinical trial success rates in breast cancer. We are now exploring whether this finding holds true for other biomarkers in other cancers.
Source: University of Toronto.