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Decentralized clinical trials offer a wide range of benefits for medical device makers and the patients they serve.With that in mind, the FDA has released draft guidance for decentralized clinical trials to advance medical product development and research.
Decentralized clinical trials use locations other than traditional clinical trial sites for some or all of the trial-related activities. That means patients who might have previously needed to travel to research sites — their doctor’s office, for example, or a university hospital — can instead participate in trials at home or closer to home.
This allows a broader, more diverse representation of the population to take part in experimental medicine, helping to reduce gender, racial or socioeconomic inequality in medical care.
“The FDA has long considered the benefits of decentralized clinical trials. Advan…