A visual safety risk evaluation tool in early clinical phases

Dynamic evaluation of safety risks across all stages of clinical development, including early trial phases, has become the norm with the evolution of risk management in pharmacovigilance. The need for practical tools directly applicable to early clinical assessment prompted the authors to pilot the customization of a common risk matrix to support proactive safety risk evaluation based on multiple dimensions. Once defined for their research area, the tailored safety risk matrix was applied to visualize a series of known risk profiles and examples, along with projected risk mitigation effects. This two-fold visualization on one simple graph (risks positioning, and effect of risk mitigation of those positions) was found to be particularly relevant in multi-disciplinary safety discussions during early clinical development stages. The visual tool provides useful snapshots of projected safety risk profiles, facilitating communication with multiple stakeholders involved in decisions throughout early clinical development. With the prospect of a simple visual instrument to add to their existing risk management toolbox and processes, clinical teams are also provided with a basic blueprint to apply and tailor based on risk dimensions related to their own research area.