Both Cochrane and Regulatory agencies work for better healthcare. The structures of the organisations and the mandates are different, but their objectives are the same. An intensified dialogue and understanding of the needs, expectations and possibilities could save duplicate work and utilise complementary and collaborative effort. This session aims at promoting a constructive dialogue between Cochrane and the European Medicines Agency.
David Tovey, Editor in Chief, Cochrane
Harald Herkner, Medical University of Vienna, Cochrane, PRAC-EMA
Hans-Georg Eichler, Senior Medical Officer European Medicines Agency
A strategic regulatory viewpoint: The role of meta-analysis in current drug licencing and future strategies (benefit risk assessment tools, adaptive licensing, specific requirements for individual patient data meta-analysis, stakeholders' interests and legal framework for data exchange). How does meta-analysis fit into contemporary concepts such as personalised medicine and comparative effectiveness?
What could Cochrane add, what could Cochrane learn from that?
Christoph Male, Paediatrician/Researcher at Medical University of Vienna, Paediatric Committee-EMA
A paediatrician's viewpoint: The role of meta-analysis in paediatric investigation plans and the extrapolation of adult population results for paediatric applications; Do eligibility criteria in clinical studies and meta-analyses contribute to knowledge gaps in paediatric pharmacotherapy? Is it sufficient to include 'children' into studies or should we be more 'age specific' in the regulatory context, for systematic reviews and in clinical practice. Is there relevant clinical heterogeneity in terms of disease spectrum, drug response or relevant outcomes to suggest separate paediatric meta-analyses?
How could the Cochrane Collaboration contribute, what could we learn from that?
Stephen Evans, Professor at the London School of Hygiene and Tropical Medicine, Independent expert member to the PRAC at the EMA, CIOMS Working Group X on "Considerations for applying good meta-analysis practices to clinical safety data within the biopharmaceutical regulatory process".
The drug safety viewpoint: Are there differences in meta-analytical approaches between regulatory and Cochrane?What are the methodological challenges of rare events, drug safety issues, observational data, large datasets or unpublished data. Do we need to advance meta-analytical methods to meet regulatory needs of drug safety? Can standard meta-analytical procedures fit into the narrow timelines of the regulatory system? Can the practised conservativism be justified for drug safety issues from a regulatory perspective?
How could the Cochrane Collaboration fit into that, what could we learn from that?
What can the Cochrane Collaboration contribute, what does the Cochrane Collaboration expect from Regulatory Agencies? What would be in an ideal world? What are the barriers? What could we change immediately, mid-term, long term? Where is a realistic potential for a collaborative effort?