A new guidance from the US Food and Drug Administration (FDA) on
risk-based approaches to monitoring clinical trials delineates how
drugmakers and clinical research organizations should oversee the
conduct of clinical studies, including the use of remote monitoring.
While trial sponsors have been free to determine how best to monitor
clinical studies conducted in disparate locations throughout the world
and advances in data gathering have made remote monitoring methods more
feasible, sponsors have traditionally seen site visits as more desirable
by FDA. This new guidance makes the case that this is not necessarily
true, and encourages the use of remote monitoring when appropriate,
based on factors including the study’s complexity.
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