Targeted or Selective Safety Data Collection in Late Pre-authorisation and Post-authorisation Clinical Trials.

Last month, FDA released its final guidance "Guidance for Industry: Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and postapproval Clinical Investigations. One thing we noticed is that in the final version, the FDA changed its terminology from "Targeted Safety Data Collection" to "Selective Safety Data Collection".

“This guidance provides recommendations on when to consider selective safety data collection and how to do so to maintain a balance between eliminating the collection of data that will not be useful and collecting sufficient data to allow adequate characterization of the safety profile of a drug,” FDA says,

The final guidance significantly revised and finalized guidance originally released in 2012. In response to public comments requesting more detail and examples, FDA says the draft guidance was revised and reorganized to clarify what types of safety data and what circumstances may be appropriate for the selective collection, in addition to more detail on the draft guidance topics and additional information on safety data reporting issues.

Following the release of the draft guidance, FDA conducted the webinar to explain the main points of this guidance. The webinar and the slides can be found here.

While FDA has the explicit guidance on the targeted/selective safety data collection, EMA's position is less clear. EMA’s clinical trial directive does not explicitly require a complete collection of all AEs and other non-critical safety data. The communications with EMA suggest that it allows sponsors to target the collection of nonserious AEs and other non-critical safety data when appropriate in post-authorization studies.

The US Food and Drug Administration (FDA) on Thursday significantly revised and finalized guidance originally released in 2012 that will help the industry understand what types of safety data needs to be collected in late-stage premarket and postapproval clinical investigations.

In response to public comments requesting more detail and examples, FDA says the draft guidance was revised and reorganized to clarify what types of safety data and what circumstances may be appropriate for the selective collection, in addition to more detail on the draft guidance topics and additional information on safety data reporting issues.

Combining with the FDA guidance "Oversight of Clinical Investigations —A Risk-Based Approach to Monitoring", we see an effort from FDA to ease the burden in conducting the clinical trial and cut the cost of drug development. Over the years, the clinical trial protocol has become so complicated, a lot of data collected during the trial has little or no value to the objective of the study, and on-site monitoring and 100% source data verification has limited improvement in data quality, but are always implemented.

Fully adopting this two guidance may be quick in the government and academic sponsored clinical trials, but it will take some time for the clinical trials sponsored by the industry for the licensure purpose.

References:

Zachary Brenan 2016 "FDA Finalizes Guidance on Safety Data Collection for Late-Stage and Postapproval Trials"