This talk will review the main methodology topics discussed in 2017 by the European network of regulatory statisticians, as planned in the Biostatistics Working Party 2017 work plan but also new topics that will need further attention in 2018. Specific time will be dedicated in this presentation to key subjects, including:
The implementation of the draft Addendum on estimands and sensitivity analysis in clinical trials by regulatory statisticians and non-statisticians;
Examples of Bayesian methods found in company proposals and an update the EMA Reflection Paper on Extrapolation;
An introduction to the EMA draft reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development, currently under public consultation.
Frank Pétavy is head of Biostatistics and Methodology Support (ad interim) at the European Medicines Agency. His Office provides statistical and methodology support to the Agency’s key processes for the development and evaluation of medicines, and actively collaborates with statisticians of EU national medicines agencies within the CHMP Biostatistics Working Party, including the development of methodology guidelines. As an EU representative, he is a member of the ICH E9(R1) Expert Working Group that is drafting the Addendum on estimands and sensitivity analysis in clinical trials.
Before the EMA Frank held a number of statistical positions over 14 years in the pharmaceutical industry (IPSEN, GSK, Amgen), covering all aspects of drug development from compound selection to post-marketing trials, in Spain and the UK. He first studied mathematics and physics in Paris and he completed a post-graduate diploma in statistics at Ecole Nationale de la Statistique et de l'Analyse de l'Information, with a specialisation in clinical trial methodology and epidemiology (Rennes, France)
Andrew Thomson is a statistician at the EMA Office of Biostatistics and Methodology Support, joining in 2014. He supports the methodological aspects of the assessments of Marketing Authorisation Applications, as well as Scientific Advice, and methodological aspects of Paediatric Investigational Plans. He has worked extensively on the methodological aspects of the EMA Reflection Paper on the use of extrapolation of efficacy in paediatric studies.
Prior to the EMA, he worked at the UK regulator, the Medicines and Healthcare product Regulatory Agency. Here he worked initially as a statistical assessor in the Licensing Division, assessing Marketing Application Authorisations and providing Scientific Advice to companies. After rising to Senior Statistical Assessor, he moved to the Vigilance and Risk Management of Medicines Division, to be Head of Epidemiology. Here he managed a team of statisticians, epidemiologists and data analysts providing support to the assessment of post-licensing observational studies and meta-analyses.
Thomson has a PhD from the London School of Hygiene & Tropical Medicine � thesis title “Design and analysis issues with Cluster Randomised Trials when the outcome is binary and the number of clusters is small�, an MSc from University of Southampton and an MA in Mathematics from Cambridge University. He also spent 2 years working at Imperial College London, in the Small Area Health Statistics Unit specialising in the use of Bayesian Spatial Smoothers.