Historical Data SIG

Objectives

Many approaches for designing and analyzing clinical trials using historical (or other external study) data have been proposed in the recent past. For example, proposals have been made for bridging studies, the combination of randomized and non-randomized evidence, and also for more general problems such as across-phases probability of success calculations. In addition, the ever-increasing number of patient registries and databases for routinely collected data, and recent data sharing initiatives (e.g., TransCelerate), further underline the importance of these approaches. However, there are still many open questions concerning the role which clinical trials that use such data can have in drug development. In our opinion, the three most important questions are:

  • What is the state of the art regarding approaches to incorporate historical data into the formal design and analysis of clinical trials?
  • Which statistical methods should we use to make historical and current data comparable?
  • What are the regulatory requirements necessary for the acceptance of historical data in drug approval?

The scope of this SIG is to provide some answers to the above questions through a variety of activities. These will include:

  • Publishing reviews of the available methods, sources of historical data and case studies.
  • Collaborating with experts to refine and possibly extend the available methods.
  • Interacting with regulators to obtain a better understanding of their requirements.
  • Providing trainings, workshops and talks.
  • Promoting good practice through templates for study protocols and statistical analysis plans.


Who we are

Name Company/Institution
Nicky Best (co-lead)
 GSK
Simon Wandel (co-lead)  Novartis
Byron Jones (Chair)  Novartis
Lisa Hampson
 Novartis
Sebastian Weber  Novartis
Frank Fleischer  Boehringer Ingelheim
Nelson Kinnersley  Roche
David Dejardin
 Roche
Ros Walley  UCB
Adrian Mander  MRC Cambridge
Graeme Archer  GSK



How to get in touch


Contact:
Byron Jones (Novartis)
Email: byron.jones@novartis.com



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EventsFuture 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.
  • 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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