Drugs

Guide on ‘Selective’ Drug Safety Data Collection

FDA has posted a final guidance entitled “E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials.” The International Council for Harmonization guidance provides recommendation on the use of selective safety data collection that may be applied in specific pre-approval or post-approval late-stage clinical trials.

“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,” the guidance says. “By tailoring the method and streamlining the approach to safety data collection, it may be possible to carry out clinical trials with greater efficiency.”

To illustrate the concept, the guidance describes an example where a drug being studied has well-characterized safety data, such as where hypoglycemia is a known adverse drug reaction and routine blood glucose monitoring is recommended in labeling. “In a clinical trial utilizing selective safety data collection, blood glucose should be monitored in the same way it would be monitored in clinical practice; however, the data do not need to be recorded in the case report form or reported to the sponsor as long as they are not stipulated in the protocol and not associated with a serious adverse event,” it says. “Blood glucose levels and hypoglycemia would be recorded in the case report form, however, if they are stipulated in the protocol, e.g., as an adverse event of special interest, deemed to be clinically relevant, or associated with serious adverse events.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome