USA – FDA draft guidance paves way for more real-world, point-of-care clinical trials

The US Food and Drug Administration (FDA) on Tuesday issued a draft guidance [Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice] that’s intended to pave the way for using data from research carried out during routine clinical practice to support drug approvals. FDA explained that during routine clinical practice, additional information is often gathered to support a wide range of purposes, for example in employment medical exams and trav...