One Framework to Rule them All
If regulators worldwide are to make good decisions in the face of complex risk–benefit profiles, a transparent and systematic approach is needed. I believe our ‘universal framework’ could be the answer.
Sam Salek |
For many years, the area of benefit–risk assessment of pharmaceutical products was almost a taboo – there was no transparency, no audit trail, and no systematic approach. Compared with 15 years ago, there is now a more systematic approach being taken in many regulatory agencies. High-profile tragedies involving approved drugs, such as Vioxx, have led to revised legislation and a new emphasis on benefit–risk assessment. But there are still many regions where these complex decisions come down to a single individual. We did a survey as recently as 2013 to find out whether regulators were using any specific criteria/model when assessing benefit and risk – we found that qualitative approaches still dominate (1).
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