Introduction To Industry Training Course 2020
The ITIT course will take 25 delegates new to the industry on a complete drug development experience from discovery to marketing. They will visit 6 companies to learn about 6 topics from experts in their field. The ITIT course will have 3 sessions in continental Europe and 3 sessions in the UK. The start of the 2020-2021 course will be delayed until face-to-face meetings with up to 30 people are permitted and companies are allowing travel again.
PSI Webinar: Patient preference studies
In this webinar you will hear an introduction to what a patient preference study is as well as an overview of where this type of study can inform regulatory decision making. This will be followed by 2 examples looking at potential approaches to eliciting patient preference.
PSI Vaccine SIG Webinar: Statistical Topics on COVID-19 Therapeutic and Vaccine Clinical Trials
We are delighted to be joined by Frank Harrell who will present 'Sequential Bayesian Designs for Rapid Learning in COVID-19 Therapeutic Trials'; and also by Dean Follmann, who will present on 'Statistical Aspects of COVID-19 Vaccine Trials'. Join us for this insightful and highly topical webinar.
Joint PSI, EFSPI & ASA BIOP Webinar: Estimands
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on this topic to date.
Special Interest Groups
The Application and Implementation of Methodologies in Statistics (AIMS)
The Benefit-Risk SIG was set up at the start of 2012 to help support those involved in this fast evolving area.
Bridging Data Science knowledge and expertise across various groups and functions within the pharmaceutical industry to increase collaboration, awareness, knowledge sharing and enhance drug development. We’ll encourage the development of new statistical and machine learning methods and approaches as well as in novel applications of the well-established methods.
Sharing experiences and challenges of external patient level data sharing with particular focus on data privacy and anonymization processes.
The Quantitative Decision-making Special Interest Group (QDM SIG) was formed in October 2017. It is a group of statisticians from industry and academia, with experience and interests in statistical methods for quantitative decision-making in drug development.
What is the state of the art regarding approaches to incorporate historical data into the formal design and analysis of clinical trials, Which statistical methods should we use to make historical and current data comparable, What are the regulatory requirements necessary for the acceptance of historical data in drug approval?
The purpose of the Healthcare Technology Assessment SIG is to provide statisticians working in the Pharmaceutical Industry engaged in Health Technology Assessments, and others in related fields of research...
This SIG will connect the following two topics: general biostatistics Neuroscience community, and working groups on estimands & other topics in Neuroscience.
A special interest group to facilitate networking amongst ‘new starters’ (statisticians and programmers) working in medical research - the pharmaceutical industry, Contract Research Organisations and Clinical Trial Units. The group will organise between one and three events per year to achieve this. Networking will be facilitated through three types of event – symposia, development and social.
The draft addendum of the ICH E9 guideline on Statistical Principles for Clinical Trials was released in August 2017 and introduced an estimand framework. In February 2018, Evgeny Degtyarev from Novartis and Kaspar Rufibach from Roche started an informal working group to discuss how to implement the draft addendum in oncological clinical trials.
Subgroup analysis is routinely conducted in drug development, in various settings; one key aspect is the regulatory requirement to demonstrate consistency of treatment effect across a pre-defined set of subgroups (e.g., ICHE5, E9, E17).
To provide a forum to discuss the statistical issues involved in Regulatory and Investigative Toxicology.
Creating a professional platform for statisticians in the Pharmaceutical industry, Regulatory agencies and Public Health organizations working on the research and development of vaccines to understand how best to apply methodologies.
Effective visualisation of data should belong to the core skills of statisticians as it represents an essential tool in exploring data as well as explaining data.