PSI Scientific Committee Webinar - Longitudinal modelling: Time to take the next step?
Longitudinal data, i.e. data that arises from repeated observations of the variable over a period of time, has long been put forward as one way to improve to the efficiency of drug development. However, even though there is a rich statistical methodology for longitudinal data, there is no full, wholehearted uptake of these methods in pharmaceutical statistics..
A PSI Training Course on ICH for Statisticians
This course will give an overview of ICH guidelines for all statisticians in the setting of drug development trials and drug approval in the pharmaceutical industry.
PSI Webinar - Overview and awareness about quantitative decision-making in drug development
Quantitative methods to support decision-making in clinical drug development already exist, but may be unknown or unused by pharmaceutical companies.
PSI Webinar - Main statistical approaches for quantitative decision-making in drug development
We performed a survey among pharmaceutical companies, targeting people with different profiles (statisticians, non-statisticians and decision-makers) working at different stages of the clinical development (study level, development level or portfolio level).
PSI Training Course - Bayesian Practical Course using R and SAS
This practical training course will give a deep dive into performing Bayesian analyses in R and SAS. It is aimed at statisticians who need to be able to conduct Bayesian analyses as part of their day to day work. By the end of the course participants will be able to conduct their own analyses.
Medical Statistics Careers Event 2020
Our annual PSI Medical Statistics Careers Event, will be held at the De Montfort University in Leicester on Wednesday 4th March 2020.
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 from October 2020 to July 2021 to learn about 6 topics from experts in their field. The ITIT course will have 6 sessions in continental Europe and 3 - 4 sessions in the UK. It promises to be a truly memorable course.
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.
The PSI / EFSPI Biomarkers Special Interest Group has been formed with the aim of developing knowledge and opinions within the statisticians about biomarker usage and the related statistical and study design techniques that are involved.
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...
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.
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.