ICH has released a new E series guideline for consultation: ICH E19 – Optimisation of Safety Data Collection
Objective of the Guideline
This Guideline is intended to provide internationally harmonised guidance on an optimised approach to safety data collection in some late-stage pre-approval or post-approval studies when the safety profile of a drug is sufficiently characterised. Optimisation of safety data collection using a selective approach may improve the efficiency of clinical studies while reducing the burden to study participants. Adoption of an internationally harmonised approach to selective safety data collection may facilitate global participation in clinical studies.
Regulators and industry have a shared interest in reducing the burden to study participants while facilitating the conduct of studies that could yield important new medical knowledge and advance public health. Although safety monitoring of patients during clinical studies remains critically important, unnecessary and burdensome data collection may serve as a disincentive to participation in clinical studies, e.g., frequent and time-consuming patient visits; laboratory tests; and/or physical examinations.
Knowledge about a medicinal product’s safety profile continually evolves as safety data accumulates. Throughout the course of medicinal product development and subsequently while the drug is marketed, sponsors collect extensive safety-related data, including all vital signs, laboratory data, and adverse events. In the later stages of drug development, and if the safety profile is well-understood and documented, comprehensive collection of all safety data may provide only limited additional knowledge of clinical importance. In such circumstances, a more selective approach to safety data collection may be adequate and optimal, as long as the study objectives and the welfare of study participants are not compromised.
Importantly, sponsors and investigators should ensure that routine patient care is not compromised by the selective safety data collection approach outlined in this Guideline. It is recognised that safety monitoring serves to protect individual study participants and will continue to be performed as per standard of care.
Scope of the Guideline
This guidance is intended to apply to collection of safety data during the late-stage development of medicinal products in interventional and non-interventional studies, in the post-approval setting and, for specific cases, in the pre-approval setting.
In the pre-approval setting, comprehensive safety data collection is expected in order to elucidate frequency, severity, seriousness, and dose-response of adverse events, including potential differences across subsets, e.g., demographic; concomitant illnesses; and/or concomitant therapy. However, even before approval of a new medicinal product, if there is agreement with regulatory authorities that sufficient safety data are available or are being collected in ongoing late-stage studies, selective safety data collection may be appropriate in certain studies.