When performing relative safety assessment the safety profile of the pharmaceutical is assessed in comparison to the comparator(s) of the same or different therapeutic class and to the safety profile of non-pharmaceutical alternatives (when available).
It is important to carry out balanced assessments of the interventions, taking into account both beneficial and adverse effects, in order to support clinicians, policy makers and patients in making informed decisions. For this reason beneficial and adverse reactions/effects should be assessed with similar methodological rigour and accuracy. Although the importance of a balanced assessment is well recognised the assessment of adverse reactions/effects is still more troublesome than the assessment of benefits. In this guideline some important methodological issues concerning relative safety assessment have been addressed and recommendations were given.
Please find the guideline on safety at the bottom of this page.
This document is part of the JA1 Final Technical Report as Deliverable “D3-2 WP5_3a4_Safety”.
NOTE: For the full Technical Report, please follow this link.