External Affairs

Chair: Ray Harris

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.

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Future Events

A PSI Training Course on Improving Influence and Increasing Impact: Communication Skills for Industry Statisticians - Dates: 16 – 16 Sep, 2019

This 1-day course will lead participants, in a non-threatening and encouraging atmosphere through steps to focus on improving the key skills of making impactful verbal and written communications.

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PSI Webinar: Adaptive design: updated draft FDA guidance and its implications - Dates: 04 – 04 Jul, 2019

In September 2018 the FDA published a guidance on adaptive design for clinical trials of drugs and biologics, updating (not finalizing) its initial draft from February 2010. The main focus of the webinar will be to provide an overview of its main contents, which will be presented by Jürgen Hummel (PPD). In addition, Kaspar Rufibach (Roche) will introduce an open-source statistical software for adaptive designs, RPACT (an R package that enables the design and analysis of confirmatory adaptive clinical trials). Kit Roes will also comment on the guidance from a European Regulatory perspective, which will be followed by a brief panel discussion.

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