“Risk based monitoring (RBM) refers to a nascent change in the way that we design clinical trials of new drugs and devices and how we manage those trials to reduce risk to patient safety and data integrity. Proponents also argue the approach will bring cost savings. Given that drug development in particular is a very long and costly process (estimates vary wildly but 1BN US Dollars is a commonly quoted number to get a drug to market) new methods that can save time and money always create noise in the clinical trials world.”

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