USA – FDA draft guidance paves way for more real-world, point-of-care clinical trials

The US Food and Drug Administration (FDA) on Tuesday issued a draft guidance [Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice] that’s intended to pave the way for using data from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 travel visa applications, not to mention exams or procedures needed to inform standard randomized clinical trials (RCTs). Data from routine clinical practice has also sometimes been used to support the approval of new indications for approved drugs, as seen with FDA’s 2020 nod of tocilizumab (Genentech’s rheumatoid arthritis drug Actemra) for treatment of hospitalized COVID-19 patients, based on UK clinical practice data.

More information on the Regulatory Focus Website.