The UK MHRA and Health Canada have collaborated to publish guidance to improve the safety of patients in clinical trials through improved quality of the periodic safety reports known as Development Safety Update Reports (DSURs).
The guidance will improve the safety surveillance of clinical trial participants in the UK.
About DSURs
DSURs review the safety of medicinal products used in clinical trials and are produced every year. Currently, even though trial sponsors will have conducted assessments regarding safety concerns, these detailed safety assessments are not always included in the DSUR. This makes it difficult for some regulators to find out if all safety concerns have been thoroughly investigated and whether appropriate measures have been taken to mitigate the risks associated with the use of the investigational medicinal products during a trial.
About the guidance
The joint MHRA/Health Canada guidance:
- will improve transparency and ask sponsors to explain in the region-specific information section how they assessed the data included in the DSUR
- builds on relevant existing international standards, including the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance E2F, the Council for International Organisations of Medical Sciences (CIOMS) Working Group VII as well as each country’s relevant clinical trial legislation.
By increasing DSUR transparency requirements globally:
- patient safety is safeguarded
- regulators can monitor how safely medicines are being investigated.
This joint guidance with Health Canada reflects the UK effort to demonstrate how international collaboration contributes to international research, patient safety and global public health.
Source: MHRA website