The US Food and Drug Administration (FDA) recently opened for comment until 26 August a guideline from the International Council for Harmonisation (ICH) on how to collect safety data in some late-stage pre-approval or post-approval studies when the safety profile of a drug is sufficiently characterized.
The 10-page draft of E19, endorsed by the ICH Assembly on 3 April, is part of efforts to reduce the burden on study participants while facilitating studies that can advance public health.
The guideline notes the types of safety data where it may be appropriate to limit or stop collection, which could include non-adverse events, routine laboratory tests, information on concomitant medications, physical examinations (including vital signs) or electrocardiograms. But the guideline also describes the types of safety data that should always be collected, including deaths, serious or significant adverse events, overdoses and several other categories.
“When sponsors choose to implement selective safety data collection for a clinical study, a scientific justification should be provided,” the guideline says, noting specific factors that would be appropriate in making such a determination. Such factors could help speed to market a medicinal product under investigation that has received a marketing authorization from a regulatory authority in the same indication as the one under investigation…