FDA loosens clinical trial guidelines


According to Outsourcing-Pharma.com:

    The US Food and Drug Administration (FDA) has signalled it will soon allow a new “adaptive” approach to clinical trials in order to streamline drug testing and speed drugs to market.

    The changes are designed to help the pharmaceutical industry save millions of dollars in drug development costs - which are currently skyrocketing - by saving time, preventing the number of study failures, and reducing the number of study participants required by over 30 per cent.

Among the proposed changes are allowing clinical trial sponsors to check results halfway through and modify the design of the trial to better their odds of getting better results, or cancelling the study if the results aren't looking so good. Of course, some are concerned that this approach could lead to trouble, saying the current guidelines are there to decrease the chance of bias. The FDA is looking to address those concerns, according to the article.

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