FDA Seeks Comment on ICH Guideline on Optimizing Safety Data Collection
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.
The guideline also lists examples of when selective safety data collection may be considered, such as when it’s a new indication of an approved drug or if it’s a demonstration of superiority when non-inferiority has been demonstrated.
Changes to a selective safety data collection approach may be warranted in some circumstances, the guideline notes, such as when there is a postmarketing safety signal or there’s a concern from a data monitoring committee.
The guideline further describes methods of implementation, such as when selective safety data collection is done for all patients in a study, when it’s for a specific subset of a population or when comprehensive safety data is collected for the initial portion of a study but then selective data is collected afterward.
Mary Thanh Hai, director of the Office of Drug Evaluation II at FDA, said in April that ICH’s expert working group plans to meet next fall to review public comments on E19, and in June 2021, the guideline is slated to reach Step 4.
E19 OPTIMISATION OF SAFETY DATA COLLECTION