Slicker drug trials for personalised therapies–can they bring costs down?

In Clinical Development, Market Access, Regulation & Government by Tim Peplow

New personalised cancer therapies have been barrelling their way through clinical trials – including orphan drugs such as Zelboraf and Tafinlar, which target specific mutations in a genetic subset of melanoma patients. Referring to Stivarga, a gastrointestinal cancer drug which gained FDA approval based on a single clinical trial of 250 patients, a cancer specialist told Reuters that the drug’s approval “was like a land-speed record.”

Do personalised medicines such as Zelboraf, Tafinlar and Stivarga justify changing the way some drugs are put through clinical trials? If we removed the need for randomized controlled trials, and approved drugs based on the results of single-arm studies in the specific subsets of patients that these drugs are designed to treat, could we reduce the cost of drug development and ultimately reduce the cost of drugs to payers? If clinical trials – a very expensive part of drug development – become slimmer, slicker and more streamlined, can drug costs come down?

Read more at Reuters >

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