Reuters recently reported that shifting clinical trial practices have the potential to lower prices for cancer drugs in the United States and abroad. Conventional drug development has stood by randomized trials with the classic ‘placebo’ or ‘control’ groups being compared with the substance in question to see if a drug actually worked. Though this is the standard for conventional drug development, it is a very expensive process that translates to higher prices during the patent protection in the US, as companies try to make up their development costs and generate profitable returns.
For drugs that target disorders with specific genetic traits, there are more effective alternatives that can translate to lower development costs. These alternatives include targeted clinical trials, which have shown remarkable results in recent news. For example, Roche’s Zelboraf, a drug that targets specific mutations in cancer cells, resulted in 8 out of 10 patients with a specific genetic makeup in an early-stage clinical trial having significant reduction in tumor size.
It is apparent that these targeted trials have huge potential to take advantage of the trends of increasing use of genetic testing in medicine today. With increasing FDA flexibility with regards to approval of breakthrough drugs, speeding up the approval process and improving its priority review system, 2013 has been a successful year for the development of pharmaceutical innovation.
- How new cancer drugs can skip randomised trials (themalaysianinsider.com)
- UPDATE 1-INSIGHT-How new cancer drugs can skip randomized trials (uk.reuters.com)
- ‘We won’t have to do those dinosaur trials.’ How new cancer drugs can skip randomized tests (theglobeandmail.com)