ICON’s safety surveillance services employ a robust signal detection and management framework to identify potential risks posed by medicinal products. A dedicated global team utilise the latest validated technology combined with tested procedures to ensure continuous monitoring of these products from clinical trials to the post-market phase.
A medicinal product must undergo safety surveillance through a strictly controlled clinical development process (which can continue after the product is licensed), to qualify for patient use. The net benefit of a potential medicinal product is dependent on mitigating any associated safety risks. Good Pharmacovigilance Practice provides an industry based, structured methodology for signal detection for the identification of risks for a medicinal product.
Pharmacovigilance regulations are implemented to ensure identification and monitoring of safety concerns, analysis of data and risk assessment in a continuous and systematic manner. The change in the European Union Clinical Trial Regulation has also impacted safety reporting measures in EEA member states, further strengthening safety protocol and surveillance for medicinal products. ICON’s processes follow these strict regulations in developing their safety surveillance plan based on the five-fold system of detection, validation, assessment, recommended action and communication of findings while ensuring signal prioritisation and tracking.
Signal detection pertains to the identification of potential safety issues associated with a medicinal product using qualitative and/or quantitative analysis of safety data from different sources. The validation process analyses the strength of available evidence, their clinical relevance and previous awareness of the association, which is followed by further assessment, signal to risk translation and benefit risk evaluation. Actions are recommended in the event of confirmation of a safety issue. Finally, the findings are communicated to the stakeholders.
The detection process can be divided into the following phases:
Generating Signal Detection Strategy
The strategy for detecting signals is based on the product safety profile, the available data sources, signal detection method and data output format. It also requires the involvement of a Safety Surveillance Team (SST) and implementation of a governance structure. Every product passes through this signal detection cycle, and the strategy helps in identifying the relevant clinical and safety data to be reviewed by the SST. Additionally, details associated with each phase in the safety surveillance process are available for reference.
Conducting Signal Detection Review
ICON uses SIGNET, a data visualisation tool, for safety surveillance and signal detection. It uses near real-time data, is cost-effective and time efficient. Raw clinical, safety and public data are ingested into the tool and the resulting visualisations help in identifying trends and areas of interest by allowing ‘slicing’ and ‘dicing’ of data.
Managing Signal Detection Findings
Based on signal detection findings a report is prepared. Validation and assessment of signals take place after signal detection findings are reported. The SST, which includes client representation, confirms signal validation and assessment criteria and conclusions, and proposes actions to manage and minimise safety risks associated with the product. ICON also uses Orbit™ to track the flow of activities related to detected signals and that of further actions resulting from signal assessment.
Overall, ICON processes for safety surveillance involve an extensive plan of managing the safety profile of medicinal products in accordance with country specific safety regulations for Sponsors and Market Authorisation Holders for a well-controlled product life-cycle that ensures drugs are safe for use.