Publicly Available Clinical Trial Safety Data: Review and a Call for Standardization and Improved Reporting Practices

Area of Science:

• Pharmacovigilance and Drug Safety
• Clinical Trial Data Transparency
• Regulatory Science

Background:

• Comprehensible reporting of clinical trial safety data is vital for stakeholders, including regulatory safety reporting.
• The consistency and completeness of safety event of interest (EOI) information in public sources are not well understood.
• This study assesses the availability and transparency of adverse event (AE) information in public clinical trial data.

Purpose of the Study:

• Examine the utility of public clinical trial data sources for signal detection.
• Evaluate the contextualization of serious or severe (grade ≥ 3) events of interest (EOI) rates.
• Assess the availability and transparency of adverse event (AE) information.

Main Methods:

• Conducted a structured review of 44 EOIs for ten medicinal products approved in the US and EU.
• Evaluated safety data from journal publications, ClinicalTrials.gov, FDA, EPARs, and product labeling.
• Assessed parameters including demographics, disease severity, SAE frequency, exposure-adjusted rates, and EOI identification clarity.

Main Results:

• Clinical summaries from Drugs@FDA and EPARs offered the most participant characteristic data.
• Most publications provided demographic and disease severity data; geography was less common.
• SAE frequency was generally available, except in product labeling; EOI information was most frequent in Drugs@FDA and EPARs.
• ClinicalTrials.gov lacked event adjudication details and exposure-adjusted rates.
• All sources frequently omitted treatment exposure duration and clear EOI identification methods; standardized queries were rarely used.

Conclusions:

• Public clinical trial data often lack the detail needed for contextualizing serious/severe EOI rates.
• Improved access to treatment exposure data and clearer EOI identification are essential.
• Enhanced availability of safety information supports pharmacovigilance and improves benefit-risk assessments.