The United States (US) Food and Drug Administration (FDA) have asked for comments on a guideline from the International Council for Harmonisation (ICH) on how to collect safety data in certain late-stage pre-approval or post-approval studies when the safety profile of a drug is sufficiently characterised. The guideline is open for comment until 26th August 2019.
The draft guideline, which was approved by the ICH Assembly on 3rd April, aims to reduce the burden on study participants whilst facilitating studies to advance public health. The guideline outlines the various types of safety data where it may be appropriate to limit or stop collection, including non-adverse events, routine laboratory tests, and information on concomitant medications, physical examinations or electrocardiograms. It is important to note that the guidance also states the types of safety data that should generally be collected under all circumstances, such as deaths, serious adverse events or significant adverse events that led to an intervention.
The guidance states that “when sponsors choose to implement selective safety data collection for a clinical study, a scientific justification should be provided”, and specific factors that would be appropriate in making such a determination are outlined. These specific factors may help increase the speed to market of a medicinal product which is under investigation that has received a marketing authorisation from a regulatory authority in the same indication as the one under investigation.
Selective safety data collection may be considered in certain situations, for example when it is a new indication of an approved drug, or if it is a demonstration of superiority when non-inferiority has been demonstrated. In some circumstances, it may be appropriate to change a selective safety data collection approach, such as when there is a post-marketing safety signal or a concern from a data monitoring committee.
Methods of implementation are described in the guideline, for example when selective safety data collection is done for all patients in the study, when it is 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.
The director of the Office of Drug Evaluation II at the FDA stated in April that the ICH expert working group are planning to meet next autumn to review public comments on E19, and the aim is for the guideline to reach Step 4 in June 2021.
To read the ICH guideline E19 optimisation of safety data collection, please click here.