EMA Adopts ICH E19 Guidelines on Selective Safety Data Collection
The European Medicines Agency (EMA) has endorsed the International Council on Harmonization’s (ICH) guideline on ways to be more selective in collecting safety data in late-stage and postmarket trials.
The guideline, ICH E19, defines selective safety data collection as “the reduced collection of certain types of data in a clinical trial after thorough consideration of factors that would justify such an approach.”
The council’s recommendations for selectively gathering safety data mainly pertain to postmarket interventional trials, as comprehensive collection is usually expected in preapproval trials, but it does apply to late-stage preapproval trials in certain situations.
E19 presents both general considerations on participant safety, justifying selective safety data collection, data that may be appropriate for selective gathering, benefit-risk considerations and situations in which selective collection should be considered, as well as a section on actually implementing a streamlined safety data collection approach.
Per the guidelines, any selective safety data gathering strategy should be carefully designed and clearly described in the protocol, monitoring plan and statistical analysis plan, and references should be made to ICH E19. And because investigators may be unfamiliar with such an approach, it’s important that case report forms are well designed and investigators trained appropriately, the guideline says. The approach(es) should also be described in relevant documents when safety findings are presented.
The EMA is the first of the ICH member regulators to adopt the new guideline.
Read the full ICH E19 guidelines here: https://bit.ly/3T1QPOx.