FDA Adopts ICH E19 Guidelines on Selective Safety Data Gathering
In an effort to improve the efficiency of late-stage and post-approval trials, the FDA has endorsed the International Council for Harmonization’s (ICH) E19 guidelines, which offer considerations for selectively collecting safety data, in final guidance published Monday.
In the view of the FDA, selective safety data collection — the reduced collection of certain safety data after careful, thoughtful consideration — can lead to greater productivity in trials and enable larger-scale research efforts. The ICH E19 guidelines, titled “A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials,” mainly pertains to safety data in interventional post-approval trials but may be applicable in phase 3 trials in certain instances.
In situations where there is strong understanding and documentation of a drug’s safety profile, gathering comprehensive safety data may only add limited clinical knowledge, the FDA’s final guidance explains. In these circumstances, a more thought out and selective safety data gathering approach may be useful.
“By tailoring the method and streamlining the approach to safety data collection, it may be possible to carry out clinical trials with greater efficiency. This may facilitate the conduct of large-scale efficacy and safety clinical trials with large numbers of participants and long-term follow-up,” the FDA said.
The guidance goes into general principles, such as on justifying selective safety data collection, ensuring the safety of participants, data that should generally be collected and benefit-risk factors to consider when selectively gathering data, as well as sections on implementing a more selective approach, practical considerations and how ICH E19 should be considered alongside other guidances and regulations.
The EMA was the first ICH regulatory agency member to endorse the ICH E19 guidelines, doing so at the end of November (CenterWatch Weekly, Nov. 30).
Read the final guidance here: https://bit.ly/3VTADjW.