Real World Data

The Real World Data SIG (formerly Epidemiology and Drug Safety SIG) has now been in operation since 2008 and continues to provide a forum for discussing statistical issues relating to Real World Data and Drug Safety across the pharmaceutical industry. Our objective is to discuss methodological aspects related to real world evidence generation and form a consensus on the best statistical practice in various areas of Pharmaco-epidemiology and Drug Safety.

Purpose

The purpose of the Real World Data Special Interest Group (RWD SIG) is to provide statisticians working in the Pharmaceutical Industry engaged in Real World Data Analysis, and others in related fields of research, an opportunity to:

  • Maintaining a strong alliance within the "statistics community" to respond to industry-wide issues regarding RWD and Drug safety
  • Collaborate and discuss strategies and methodology being applied in this area of research
  • Exchange information and share case studies and statistical/analytical challenges faced in RWD research
  • Keep abreast of new research and methodological developments
  • Promote and highlight opportunities for statisticians to make a positive impact in RWD
  • Interact with key opinion leaders in RWD research
  • Organize and/or participate in workshops related to RWD.

Steering committee:

The RWD SIG Steering Team consists of 7 members:

 

Name

Company

Dr George Quartey

Genentech (Chair)

Dr Maurille Feudjo-Tepie

Amgen

Dr Joseph Kim

IMS Health

Dr Jixian Wang

Celgene

Nilani liyanage

Ipsen

Dr Jonathan Alsop

Numerus Ltd

Arlene Gallagher

MHRA

In addition to the Steering Committee the RWD SIG mailing list contains over 100 other individuals (both PSI/EFSPI members and non-members) who have been involved in SIG events or have requested to be included on email updates sharing SIG events and relevant related materials that may be of interest. If you would like to be added to our affiliate’s mailing list, please email Dr George Quartey (quarteyg@gene.com), or go to the SIG area on the PSI or EFSPI website.

Latest News

The RWD SIG spent a great deal of time collaborating and sharing experiences of RWD and Safety research.

Plans for 2014 include:

  • New RWD Analytics Handbook for Statisticians ( due Q3 2014)
  • One-Day Scientific Meeting on “Post Authorization Safety and Effectiveness Studies: Regulatory-Industry Perspectives and Challenges”at Amgen Uxbridge planned for 21st October 2014.

Key topics to be discussed include:

  • Recent Changes in EU Legislations: PASS and PAES (Dr Andrew Thompson-MHRA)
  • PASS and PAES Process: Who are reviewers, What is their perspective and How it is organized, how do they react to Practical challenges such as market penetration issues etc. (Dr Jim Slattery-EMA)
  • Some reflections on how industry can organize themselves to rise to these new demands–[Dr Andrew Roddam (GSK) and Dr Jamie Robinson (Roche)].
  • Methodological Challenges in conducting PASS/PAES effectively [Dr Maurille Feudjo-Tepie (Amgen)]
  • PAES/PASS data Opportunities and Challenges and How the CPRD can optimally be used to answer some of these questions/requests[ (Arlene Galagher-MHRA)]

 

Latest News


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EventsFuture Events


  • 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.
  • PSI One Day Meeting: Estimands – Examples for Statisticians! - Dates: 27 – 27 Sep, 2017

    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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