Best Practices for Informing Benefit-Risk and Communicating Safety Information

Recent advances in analysing and reporting clinical trial safety data have not yet led to clearer communication of safety profiles in prescribing information. Adverse drug reactions are often presented as simple percentages without sufficient context on timing, exposure, severity, reversibility, background risk, or clinical relevance, limiting informed benefit–risk decision-making.

A landscape review explores drug safety communication, benefit–risk judgement under uncertainty, and decision-making safeguards used in other high-consequence fields. Findings suggest that many communication challenges stem from upstream decision-making issues, including poorly framed questions, hidden assumptions, value judgements, and insufficient challenge. These cannot be addressed through improved presentation alone.

The project aims to enhance how safety information supports benefit–risk decisions by identifying ways to communicate safety findings more clearly, meaningfully, and transparently. It evaluates how safety data are summarised and contextualised to better reflect the underlying evidence and clinical relevance. The project also considers structured benefit–risk frameworks, estimands, and aggregated safety assessments across studies. Deliverables focus on practical communication principles, illustrative examples, and consensus recommendations that stakeholders can apply directly.

Katarina Hedman, AstraZeneca

maiLkhedman@gmail.com

Nicola Newton, PHUSE Project Coordinator

nicky@phuse.global