News

ESIG of the month - May 2022

May 26, 2022, 13:58 PM

Real World Data SIG

Overview
Created in March 2021, the RWD SIG aims to increase collaboration and enhance awareness of strategies and methodologies applied in the utilization of Real World Data in the pharmaceutical industry.

The objectives include facilitating the sharing of case studies and experiences in this area and identifying emerging news and trends. The SIG will collate and summarise publications, articles, presentations, training; organise/participate in workshops related to RWD; and aim to develop or highlight best practices.

Updates & Highlights

  • Use of Real-World Data (RWD) is often constrained by the type of endpoints considered. Particular limitations arise for Time-to-Event (TTE) endpoints where there are differences in missing events between trial data and RWD, definition of “time zero”, reporting bias, immortal time bias, among others. A poster was presented at EU ISPOR  2021 by the Methodology sub-team of the SIG: ISPOR - Leveraging Real-World Data for Time-to-Event Endpoints in Clinical Trials

  • The FDA Real-World Evidence (RWE) Framework was published in Dec. 2018, shedding some light on how Real-World Data (RWD) can be used to support regulatory decision making. In July 2021, tacrolimus was approved for Lung transplantation based solely on RWE and the involved parties shared their experience with statisticians in the pharmaceutical community: PSI RWD SIG Webinar: Real-World Evidence Submission - a Case Study in Lung Transplantation (psiweb.org)
News 2022
  • We will be launching the “Let’s Talk Re@l” corner. Watch out for discussions on RWD topics and event highlights.
  • Join us at the PSI conference and come meet the PSI RWD SIG team. The PSI RWD SIG session will be 10:30-12:00 on 14th June.

New members are welcome! If you’re interested in finding out more, please contact Josie Wolfram & Anny Stari for further information.

Upcoming Events

PSI Training Course: Introduction to Machine Learning

This course is aimed at clinical trial statisticians who are new to or with limited experience of machine learning. Attendees will learn about a range of topics in machine learning, including practical sessions in R.

Joint PSI/EFSPI Vaccine SIG Webinar: Statistical and Mechanistic Models for Correlates of Protection

This webinar will explore two different approaches to Correlates of Protection in vaccine development.

Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars

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 Webinar: Drug Development in Women's Health

The event will open with an overview on drug development in women’s health from a clinician perspective. This talk is followed by talks about statistical challenges when planning IVF studies and analysing the menstrual cycles.

PSI Webinar: Surrogacy

This webinar will provide an overview of surrogacy for licensing and reimbursement. In turn, the need of extensions of the SPIRIT and CONSORT statement will be defined and outlined, with case studies to support.

Joint PSI/EFSPI Pre-Clinical SIG Webinar: Virtual Control Groups in Toxicity Studies

Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.

Joint PSI/EFSPI Data Science SIG Webinar: Developing Digital Measures (Digital Biomarkers) in Drug Development – insights from Mobilise D consortium

We will share a brief overview of what Mobilise D is and why it is an important step stone in the development of digital biomarkers, and how Mobilise D outputs can be relevant for you.

PSI Career Young Virtual Event (Q2 2024)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

PSI Career Young Virtual Event (Q3 2024)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

PSI Introduction to Industry Training (ITIT) Course - 2024/2025

An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.

PSI Career Young Virtual Event (Q4 2024)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

Latest Jobs

Statistician, Data Science

We have exciting new opportunities available for Study Statisticians, Support Statisticians and Exploratory Statisticians at various levels.