News

ESIG of the Month - October 2021

Oct 15, 2021, 10:28 AM

Why do we have a Data Sharing ESIG?
Clinical data has greater use beyond the original trial. These data can be used to further increase our scientific understanding of diseases and their treatment for the benefit of future patients. Dataset re-use is increasingly becoming part of good trial practice e.g. use of historical control arm data for planning, adding together the findings from many trials, and doing methodology work to improve the way we do future trials. Alongside this, clinical trial documents are increasingly required to be open to access to the public within the regulatory framework (e.g. EMA Policy 70, EU CTR).  All this is challenging, as both the data privacy and the regulatory framework continue to evolve.

Who are we?
This ESIG comprises statisticians (both from pharma and academia) and some policy experts who are working or have interest in the data re-use, data privacy and data sharing space.

What’s our purpose?
1. Promote an understanding of the challenges and responsibility organisations and statisticians have when re-using or sharing clinical data.

2. Improve understanding, implementation and data privacy concepts within the context of clinical trial data sharing.

3. Influence and shape the environment and policies regarding clinical data sharing.

4. Collaborate with other groups and stakeholders in this area.

Want to know more?
Check out the resources we have on our ESIG page.

Would you like to join us?
New members are welcome! If you’re interested in finding out more please contact Rebecca Sudlow or Mimmi Sundler for further information.

Upcoming Events

PSI VisSIG Wonderful Wednesday Webinar Series

This is a good opportunity to develop your knowledge by thinking through a practical example, practicing how to apply graphics principles, and developing your coding skills.

PSI Book Club

PSI are running a book club! We will be reading and discussing non-technical books which are relevant to our roles.

PSI Scientific Meeting: Adaptive Designs and their Application

Join us to here about some hot topics in the area of adaptive designs and associated methods. There will be a mixture of cutting edge methodology and real world applications. Along with the opportunity for plenty of discussion and sharing of ideas and opinions!

PSI Scientific Meeting: Decentralised Clinical Trials

In this event we will hear from expert speakers on the statistical and operational challenges and considerations of decentralised clinical trials, the promise of digital health data and wearable technology, as well the regulatory perspective to such studies

PSI Vaccines SIG Webinar: Assessing Population Level Vaccine Effectiveness Under Different Study Designs

This presentation provides a brief description of the herd protective effects of the oral cholera vaccines, as an example, that have been evaluated for herd protection in various study settings, leveraging the geographic information system (GIS) tools for analyses.

PSI Webinar Series: Showcasing R use in Pharma

Talks in these webinars will cover general frameworks for app development, regulatory submissions using R and case studies of using R Shiny in both operational and methodological settings.

PSI Careers - MEDMathS: Medicine Empowered by Data, Maths and Statistics

In just 1 hour, learn about the field of medical statistics and how it plays a crucial role in developing ground-breaking new medicines, vaccines and healthcare products.

Joint PSI & EFSPI HTA SIG Webinar: Statistics in EU HTA - PICOs, Estimands & More

The EU regulation on Health Technology Assessment (HTA) is coming into force from 2025! But why should pharmaceutical statisticians care? Join our webinar to find out more…

PSI Medical Statistics Careers Event

Our annual PSI Medical Statistics Careers Event, will be held in person at GSK House in Brentford, London on Wednesday 7th December 2022, and will feature live presentations from new starters, a panel discussion with industry representatives, and an exhibition session.

Latest Jobs

Apprentice Biostatistician

The Apprentice Biostatistician splits their time between working for Parexel and performing studies with a university to obtain a MSc in Statistics over a period of three years.

Manager Biostatistics (m/f/x)

Manager Biostatistics is responsible, under supervision, to provide statistical support to Medical Affairs (MA) and Health Economics and Outcome Research (HEOR) /Health Technology Assessment (HTA).

Manager Statistical Programming (m/f/x)

For our headquarters in Munich we are seeking highly qualified candidates to apply for Manager Statistical Programming (m/f/x).

Medical Statistics Apprentice

As an Apprentice Statistician within Labcorp Drug Development, you will play an integral role in supporting all aspects of study support functions for our testing and development work.