ESIG of the Month - August 2021

Sep 8, 2021, 09:35 AM

The Regulatory European Special Interest Group (ESIG) is probably the longest serving ESIG, although it was predominantly referred to as a committee until the end of 2020. We have a total of 20 members from 8 countries and 17 companies, and our purpose is to co-ordinate regulatory activities across the European Pharmaceutical Statistical community and to engage with European Regulatory statisticians (here is the link to our page). It is probably fair to say that the COVID-19 pandemic has stretched out colleagues in Regulatory Agencies, and as a result we have seen fewer regulatory guidelines being issued (as either draft or final). This has not reduced our activities, though, and here are some key ones coming up:

Jointly with the Biopharmaceutical Section of the American Statistical Association (ASA) we are jointly organising a webinar on Complex Innovative Designs (CID) in practice. This will be held on 21 October (14.00 – 16.00 BST), with speakers from the FDA, Novartis and GSK. If you are interested, then please find further information and a link to the registration page here.

We typically meet annually with both the MHRA statisticians and the EMA Biostatistics Working Party for an exchange of statistical topics important for both regulators and industry. The EMA has scheduled this again for 29 October and asked us and other statistical stakeholder organisations for topics. We indicated that we would like to discuss the Danish Data Analytics Center and the future plans of BSWP to analyse data, decentralised trials and the use of historical / synthetic control arm data, but have not received any further information yet on the agenda of the meeting. We will feed back on this meeting afterwards.

Finally, several of our members were on the scientific and organisational committee for the 6th EFSPI Regulatory Statistics Workshop held online between 13 and 15 September, covering decentralised trials, complex innovative designs and real world data. We hope many of you were amongst the >1000 registered attendees and enjoyed the event.

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