PSI Webinar(s): Causal inference in Clinical Trials
Over the course of two sessions, a panel of 8 esteemed speakers will give an introduction to the topic, followed by a presentation of case studies & interactive panel discussion.
Our award for statistical excellence in the pharmaceutical industry is made jointly with the Royal Statistician Society (RSS) every year.
The aim of the award is to recognise an outstanding level of influence in the application of an existing statistical practice, or an innovation, that has strengthened the quality and efficiency of investigations in the pharmaceutical industry.
We look for entries that have demonstrated one or more of the following:
Nominees can be based anywhere in the world and do not need to be a member of PSI or the RSS. The award is presented at the annual PSI Conference.
Lisa Hampson was presented with the PSI / RSS Award for Statistical Excellence in the Pharmaceutical Industry. She was nominated for her work on: "Improving the assessment of the probability of success in drug development: A holistic framework encompassing statistical significance, regulatory approval, and market access". Distinguishing it from existing approaches, this framework adopts a broader definition of ‘success’ that bridges statistical significance, clinical relevance, benefit-risk assessments, regulatory alignment, and market access as well as technical development, quality and compliance considerations.
This approach was endorsed by the Novartis Innovation Management Board, chaired by the company’s CEO, in September 2020 and has since then formally been rolled out across the entire portfolio.
In 2022, the PSI/RSS award was presented to a team of biostatisticians and statistical engineers from the healthcare company Roche, in collaboration with the University of Bath. Their winning entry was focused on ‘Standard and reference-based conditional mean imputation (methodology and open-source software)’. The team comprising of Marcel Wolbers, Alessandro Noci, Paul Delmar, Craig Gower-Page, Sean Yiu (of Roche) and Jonathan W. Bartlett (of the University of Bath) were praised by the judges for their innovative approach.
The project addressed the need of trial statisticians in the pharmaceutical industry to fully align their analysis strategy with the targeted estimand and flexible missing data assumptions for clinical trials with continuous longitudinal outcomes. The team present a novel imputation procedure which is fully deterministic (i.e. free of Monte Carlo error) and provides treatment effect estimates consistent with the Bayesian approach as well as reliable frequentist and inference with accurate standard error estimation and type I error control. The companion open-source R package ‘rbmi’ is a flexible toolbox to implement these methods in practice.
Chrissie Fletcher, Chair of PSI, said: ‘The PSI/RSS Statistical Excellence in the Pharmaceutical Industry Award is a significant achievement and recognition of a new statistical innovation created to advance drug development. Well done to the team at Roche who have applied innovative statistical thinking to a common issue in clinical trials relating to missing data and also provided a new R package to implement the methodology.’
Stian Westlake, RSS CEO, added: ‘The team are to be congratulated for this outstanding piece of work which could potentially be a big game-changer for the industry.’
In 2023, Dr Satrajit Roychoudhury of Pfizer won the award for his significant impact in developing, implementing and disseminating efficient statistical methodology in four distinct areas:
For his work on COVID-19 vaccines, he has recognised the urgent need to evaluate and identify a vaccine, but also to enable communication of findings to end users. The end result was one of the first Bayesian Phase III trials that has led to regulatory approval. For many researchers, developing novel methodology ends with acceptance of a manuscript or when the methodology is used in practice. Dr Roychoudhury has gone well beyond that and made it his mission to also educate the wider community on these methods.
Chrissie Fletcher, chair of PSI, said: 'Many congratulations to Satrajit for this significant achievement and well deserved recognition for his statistical excellence in the Pharmaceutical Industry. It is truly outstanding to implement and disseminate efficient statistical methodology in not just one, but four, important and diverse areas. An amazing accomplishment, well done.'
Dr Andrew Garrett, president of the RSS, commenting on the news said: 'Congratulations to Satrajit who should be applauded for the breadth and depth of his contributions. His work on Covid-19 vaccines clearly illustrates impact - notably how Bayesian methods can be used in a confirmatory setting to support regulatory review and approval.'
Over the course of two sessions, a panel of 8 esteemed speakers will give an introduction to the topic, followed by a presentation of case studies & interactive panel discussion.
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