External Affairs

Chair: Kevin Carroll

External Affairs is PSI’s newest committee. Our remit is to promote, amongst members of the pharmaceutical industry and the general public, a proper understanding of risks, benefits and associated statistical issues as they relate to pharmaceutical research, development, manufacturing and marketing.

This will be achieved by:

  • A programme of interactions with the media, including the submission of letters and articles to learned and lay press and other media outlets.
  • A programme of activities designed to highlight to the pharmaceutical industry (e.g., companies and professional bodies) the importance of statistics and appropriate statistical methods.
  • A programme of activities designed to highlight to people and bodies of influence (e.g., political organisations and politicians, regulatory bodies) the importance of statistics and appropriate statistical methods.
  • Responding to requests for a PSI perspective on relevant statistical matters.
  • Responding to emerging statistical issues of public and/or industry significance with written or oral submissions.
  • Promoting interaction between PSI and its members and the media for example, by encouraging journalists to attend and participate in PSI events; by encouraging PSI committees to hold events that will attract journalists and interest the audiences they serve.

Latest News

The inaugural prize for statistical excellence in the pharmaceutical industry, awarded jointly by PSI and the Royal Statistical Society, was won by Dr Björn Bornkamp from Novartis, Basel, Switzerland.

Dr Bornkamp is an Expert Statistical Methodologist at Novartis and was nominated for his work on developing innovative statistical dose-finding methodology, in particular the development of the R package DoseFinding which has so far been downloaded more than 1,000 times in 2013.

Professor Dr Frank Bretz, who is the Global Head of the Statistical Methodology group at Novartis, and who submitted the nomination, said that Dr Bornkamp had 'worked tirelessly to develop a first-class software package that is not only an essential tool at Novartis, but one that is accessible from the Comprehensive R Archive Network (CRAN) and thus broadly available to the entire pharmaceutical statistics community'.

Dr Bornkamp obtained his PhD in Statistics from Dortmund University of Technology in 2009, studying Bayesian nonparametric shape constrained inference, and joined the Novartis Statistical Methodology group in Basel in 2010.  He was presented with the award at the ceremony in Newcastle on Tuesday, 3 September during the Royal Statistical Society's annual conference.

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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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