Integrated Data Analysis

EFSPI/PSI SIG on Integrated Data Analysis (IDA)

  • The aims of the IDA SIG are to:
  • Keep abreast of current methodology and practice in the integration of data in the areas of
    • Efficacy assessment in Phases II and III;
    • Evaluation of Safety;
    • Network Meta-Analysis;
    • Sharing of clinical trial data on the part of the industry,
  • Develop new methodologies or practices where needed.
  • Write position papers and engage in public debate by making presentations at public meetings and conferences.

The IDA SIG was formed at the end of 2013 and has members from many different pharmaceutical companies. There are currently six working groups looking at the following topics:

  1. Analysis of rare events in safety data (led by David Ohlssen, Novartis, and Sally Hollis, Astra Zeneca).
  2. Safety labelling of drugs (led by Brenda Crowe, Eli Lilly).
  3. Active safety surveillance using large integrated data networks (led by Andrew Bate, Pfizer).
  4. Improving decision making at the Phase II/III transition point (led by Georgina Bermann, Novartis).
  5. Network Meta Analysis (led by Chrissy Fletcher, Amgen and Byron Jones, Novartis).
  6. Data Sharing and Transparency (led by Byron Jones, Novartis).

The chairman of the IDA SIG is Byron Jones (Novartis) who can be contacted at byron.jones@novartis.com

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  • Statistics Fundamentals for Clinical Trials for Non-Statisticians (or ‘How to speak stats in a day!’) - Dates: 14 – 14 Nov, 2017

    This is a 1-day course, aimed to introduce statistics to people who work on Clinical Trials, but who are not Statisticians. No previous knowledge of Statistics is assumed as we start right at the beginning with the basics. Many practical examples are given and the emphasis is on application and understanding rather than the equations and the technical background.
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    The PSI Scientific Committee have put together this one day meeting to provide Statisticians with real world examples of how Estimands have been defined. Presenters will give their insight into discussions with colleagues, working groups and regulators and there will be plenty of opportunity to ask your questions on defining an Estimand.
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