Drugs

ICH Presentation on Selective Safety Data Collection

The International Council for Harmonization (ICH) has released a presentation outlining its finalized guidance entitled “A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials (E19).” The guideline provides recommendations on the use of selective safety data collection that may be applied in specific late-stage clinical trials (pre-approval or post-approval).

“Selective safety data collection refers to the reduced collection of certain types of data in a clinical trial after thorough consideration of factors that would justify such an approach,” ICH says. “By tailoring the method of safety data collection, it may be possible to carry out clinical trials with greater efficiency by streamlining the approach to data collection. This may facilitate the conduct of large-scale efficacy and safety clinical trials with large numbers of participants and long-term follow-up.”

The guideline also describes the types of data that may be acceptable for selective safety data collection and data that should generally be collected to ensure patient safety. Additionally, it provides examples of how selective safety data collection can be accomplished in a drug development program, and it describes “practical considerations” in the design and conduct, and the complexities for data analyses, of such trials.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome