The lecture described below was delivered at the 28th DIA Euromeeting in Hamburg Germany, on April 7, 2016.
Medical Affairs Associate
SGS – Clinical Research
- Provide a practical approach on how to monitor benefit/ risk for established products
- Explain how this approach can be applied for different type of regulatory documents such as Addenda to Clinical Overviews (ACO), PSURs and Summary of Product Characteristics (SmPC) updates
Conducting/Implementing a benefit/ risk assessment can be very challenging for “old” established products. In previous decades clinical studies often did not meet the high standards of today’s evidence-based medicine. The reliability of the study results is unclear as many studies do not reflect actual clinical practice and are therefore difficult to translate. For other studies the numbers of patients are small, data on outcomes are limited or safety results are not reported.
Scientific assessment on benefit/ risk is conducted based on the best evidence available. To gather evidence for this kind of products, apart from review of internal company sponsored studies, searches can be organized in external scientific libraries by using targeted search criteria. All data obtained can then be assessed using a stringent evidence based systematic approach to establish whether or not there is conclusive evidence. This can also be put into the context of existing treatment guidelines if available.
The main objective of this presentation is to discuss how this approach can be applied for different type of regulatory documents that are to be prepared for established products and that involve up to date benefit risk assessments such as Addenda to Clinical Overviews (ACO), PSURs and Summary of Product Characteristics (SmPC) updates. Special attention will be paid to the referral, on the basis of Article 30 (2) of Directive 2001/83/EC for established products. For this type of products, there is an increased chance that over the years EU Member States have adopted different decisions on the content (e.g. different indications, contraindications or posology) causing a need for SmPC harmonization across the EU. Further insight will be provided how a scientific rationale can be built and documented that can accompany the proposal for the harmonised SmPC to be developed by a marketing authorization holder.