Title: To use, or not to use, non-concurrent controls? “When and how to use” – these are the questions!
Date: February 24, 2022. 4pm to 7pm CET
EU-PEARL organized a webinar to discuss multi-stakeholder perspectives on challenges and opportunities for the use of non-concurrent control data in platform trials.
Augmenting control groups with non-concurrent controls can substantially improve the efficiency of platform trials but comes with the risk to introduce bias due to time trends. In this webinar, EU–Pearl representatives presented their work on frequentist and Bayesian statistical approaches to incorporate non-concurrent controls in platform trials and reviewed the current regulatory guidance on this topic. Furthermore, academic, industry and regulatory/HTA representatives shared their perspectives and experiences. In a panel discussion, risks of bias, the potential of statistical methods to adjust for these, and the regulatory acceptability of the approaches were discussed.
There was a general agreement that whether to use non-concurrent control data in platform trials is a question of bias-variance trade-off. Methodological work on the different approaches can make underlying assumptions transparent. This gives a sound basis for interdisciplinary decision-making on the choice of control groups in platform trials.
The presentation slides and recorded webinar are now available on the website.
Speakers, panellists and chairs:
- EU-PEARL members: Marta Bofill Roig (Medical University of Vienna), Scott Berry (Berry Consultants), Katharina Hees (PEI), Ursula Garczarek (Cytel), Yevgen Tymofyeyev (Janssen), and Martin Posch (Medical University of Vienna).
- Academia and public: Robert Beckman (Georgetown University Medical Center), Stephen Senn, Matt Sydes and Max Parmar (University College London), and James Wason (Newcastle University).
- Industry: Lisa Hampson (Novartis), Olivier Collignon (GSK), Olga Marchenko (Bayer), Kert Viele (Berry Consultants), and Peter Mesenbrink (Novartis).
- Regulators / HTA: Daniel Rubin (FDA, US), Julia Saperia (MHRA, UK), Ralf Bender (IQWIG, DE), Florian Klinglmüller (AGES, AT), and Andrew Thomson (EMA).