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Upcoming Events

PSI VisSIG Wonderful Wednesdays

Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.

PSI Training Course: R for SAS Users

R is quickly gaining popularity within the pharmaceutical industry due to it being a very powerful object-orientated language, and is able to produce analyses and high quality graphics. This will be a hands-on interactive course and will utilise the RStudio Cloud development environment.

PSI VisSIG Webinar: Grammar of Graphics - theory to implementation

In this talk we'll introduce the Grammar of Graphics, which allows you to compose graphs by combining independent components, and the implementation of this theory in R -- the ggplot2 package.

PSI Webinar: Oncology Ted Style Talks (with interaction)

The format of this event will include Ted Talks by all of our speakers with the opportunity for us to have a discussion together after each of the presentations.

PSI EIWG Webinar: Estimands in Oncology - How and Why

A year on after the final ICH E9 estimands addendum was published, we bring estimands to life. Members of the Estimands in Oncology special interest group will describe how the estimand framework provides a common language to describe the diversity of patient journeys and why it is important to address the right question in clinical trials.

PSI Training Course: Data Monitoring Committees (DMCs)

This course will cover the essentials of DMC set up (roles and responsibilities, DMC charter, practical considerations), as well as discussing DMC case studies and the role of DMCs in adaptive trials and during the pandemic. In addition, there will be an interactive DMC workshop.

Special Interest Groups

AIMS

The Application and Implementation of Methodologies in Statistics (AIMS)

Benefit-Risk

The Benefit-Risk SIG was set up at the start of 2012 to help support those involved in this fast evolving area.

COVID-19

Providing a forum for sharing experiences of statistical and methodological issues relating to clinical trials impacted by COVID-19, clinical trials investigating new treatments for COVID-19 and diagnostic/antibody tests for COVID-19

Data Science

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.

Data Transparency

Sharing experiences and challenges of external patient level data sharing with particular focus on data privacy and anonymization processes.

Decision Making

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.

Historical Data

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?

HTA

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...

Neuroscience-Estimands

This SIG will connect the following two topics: general biostatistics Neuroscience community, and working groups on estimands & other topics in Neuroscience.

New Starters

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.

Oncology-Estimands

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.

Pre-clinical

To provide a forum to discuss the statistical issues involved in Regulatory and Investigative Toxicology.

Regulatory

The regulatory SIG co-ordinates regulatory activities across the European Pharmaceutical Statistical community and to engage with European Regulatory statisticians.

RWD

A special interest group to increase collaboration and enhance awareness of strategies and methodologies applied in the utilization of Real World Data in the pharmaceutical industry.

Small Populations

The SIG “Small populations” provides a forum for identifying and discussing statistical methodology related to clinical development of treatments in small populations, and for sharing experiences.

Subgroup Analysis

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).

Vaccines

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.

Visualisation

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.