Regulatory

Chair: Anna Berglind        Vice Chair: Christoph Gerlinger

The purpose of the regulatory committee is to provide the Biostatistical viewpoint on regulatory issues. This includes promoting best practise, reviewing regulatory policy and guidelines, driving debate on future guidance, and engaging with statisticians in European regulatory agencies. 

The committee meets approximately every 2 months by teleconference/webex and face to face once or twice a year.

The regulatory committee will achieve its aims by:

  1. Review of draft regulatory guidelines.
  2. Expert groups.For areas of major interest, the committee will form expert groups to discuss issues with the aim of forming an industry consensus to drive debate on future regulatory policy.
  3. Communication with the membership of the EFSPI organisations.
  4. Meetings with statisticians in regulatory agencies.
  5. Cross-industry initiatives.

Composition
The committee members are:  Julie Anderson, Anna Berglind, Timothy Clark, Maylis Coste, Erika Daly, Anne Danniau, Daniel Evans, Chrissie Fletcher, Christoph Gerlinger, Kerry Gordon, Jürgen Hummel, Teppo Huttunen, Melanie Jones, Frances Lynn, Robin Mukherjee, Carol Reid, Kaspar Rufibach, Antony Sabin, Florian Voss, and Heike Wöhling.

Link to PSI organogram (updated every year with annual report, members only access)

Committee resources
Committee operating guidelines | Committee resources folder 

Achievements 2017


General
During 2017 the regulatory committee held six regular committee meetings, as well as meetings with the EMA’s Biostatistics Working Party (BSWP) and the MHRA statisticians. The committee coordinated the review of several regulatory guidance documents (more detail below). Committee members have contributed to EMA and industry workshops, as well as webinars, on topics such as estimands, first-in-human trials, and clinical trial transparency and anonymization. In addition; members of the committee helped organize the 2nd EFSPI workshop on regulatory statistics held in Basel as well as the regulatory hot topic session at the PSI conference in London.

Expert Groups
Two regulatory expert working groups have been active during 2017: the expert group on confidentiality of interim results was established following the 2016 meeting with the BSWP. This group has authored recommendations that were shared with the BSWP in 2017, and that will be shared further via a position paper. In addition, the expert group on subgroups continued the work on developing a best practice for subgroup analysis, and is currently finalizing a paper on the topic to be submitted to Pharmaceutical Statistics.

Meetings with statisticians from regulatory agencies
The EFSPI/PSI regulatory committee met with the EMA’s BSWP on October 27, 2017. Topics discussed included: confidentiality of interim results, non-proportional hazards as it relates to time to event endpoints, real world evidence in rare diseases, statistical assessment of quality attributes, and innovation in clinical trial design.

On November 20, 2017, the regulatory committee met with the MHRA statisticians in London. Topics discussed included: umbrella and basket trials, inconsistencies between hypothesis tests and estimates, statistical assessment of quality attributes, estimands, pragmatic clinical trials and the use of real world evidence/data generated in clinical practice in regulatory decision making, risk based monitoring, and Bayesian methods for incorporating historical data into paediatric trials.

Guidelines
The regulatory committee collated comments on the following documents during the year:

Special thanks to Bruno Boulanger, Maylis Coste, Erika Daly, Christoph Gerlinger and Alan Phillips for collating comments on behalf of the committee.  


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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