ESIG of the month - May 2022

May 26, 2022, 13:58 PM

Real World Data SIG

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 (
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.

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