Special Interest Groups

Our special interest groups (SIGs) are a forum for members to discuss topics of mutual interest, keep updated on developments in a particular area of industry, to organise events on their specialist field and/or to collaborate on developing the science of that field. Our current SIGs cover a wide range of topics as set out below. We also have a working party looking at the statistical implications of greater clinical trial data sharing and a group of volunteers providing a statistical briefing service on health stories in the lay media.

For further information on any of the SIGs, take a look at their pages on the website using the links below, or for general enquiries please contact Adam Crisp (adam.x.crisp@gsk.com) PSI Scientific Committee SIG liaison lead.

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.

Biomarkers

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.

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...

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.

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).

Toxicology

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

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.

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