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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EventsFuture Events


  • Expert Working Group on Confidentiality of Interim Results - Dates: 11 May, 2017

    The PSI/EFSPI expert working group on Confidentiality of Interim Results are planning to meet face to face on 11 May.
  • Estimating Sample Sizes in Clinical Trials - Dates: 28 – 29 Jun, 2017

    The three most important aspects of a clinical trial are: design, design and design. A sample size estimate is just one aspect of a clinical study design. The course describes calculations for sample size estimation in the design of clinical trials. It will be highlighted how the objectives of a clinical trial will impact on sample size calculations. The course is a practical course and all methods will be illustrated with examples and case studies.
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