PSI VisSIG Wonderful Wednesday Webinar Series
This is a good opportunity to develop your knowledge by thinking through a practical example, practicing how to apply graphics principles, and developing your coding skills.
The Regulatory ESIG discussed the implications for clinicals trials of the Russian attack on Ukraine. Most if not all international sponsors have stopped recruitment in both countries. Initially many statisticians felt that the situation is like a ‘COVID 2.0’. However, on closer inspection only some of the methodological issues are similar to COVID while others are new. To date it appears that the conduct of trials in Russia is largely unaffected by the war. In Ukraine however, trialists and sponsors do face a multitude of serious issues, e.g. destroyed source data, missing data, drastically increased rate of patients lost to follow up, patients switching centers or even countries, or investigators unable to answer queries or provide signatures.
The EMA has just published its “Points to consider on the impact of the war in Ukraine on methodological aspects of ongoing clinical trials” (for more information click here) with the following key points for statistics:
• Use the estimands framework to deal with events related to the regional crisis, i.e. revision of pre-specified estimand and/or addition of estimands may be warranted
• Intercurrent events related to the regional crisis to be addressed on the estimand level, i.e. hypothetical strategy to be considered
• Missing data due to the regional crisis to be dealt with on an estimation level, i.e. use of statistical methods aligned with the estimand of interest/MCAR assumption to be considered
• Sensitivity analyses may be required to assess the robustness of results to missing data assumptions.
To our knowledge no other health authority has published a guidance so far. In the experience of the discussants in the ESIG only a few trials of their respective companies were relevantly affected with some trials in Ukraine severely disturbed while others were virtually unaffected by the war. Hence, a trial-by-trial approach seems reasonable. All agreed that at the present state a solid documentation of the reasons for protocol deviations is key, as it is for COVID-19 related issues.
This is a good opportunity to develop your knowledge by thinking through a practical example, practicing how to apply graphics principles, and developing your coding skills.
In this talk, you will learn how to quickly explore your data in the web browser and how to create, collaborate and share interactive visualisations with others.
Dr Francq will discuss the need for analytical methods to deliver unbiased and precise results and talk in detail on confidence, prediction and tolerance intervals work in linear mixed models and the interpretation of statistical results. This will be followed by Q&A.
During this session you will explore how we best execute change within our roles, build your practical understanding of agile tools and techniques, and inspire you to experiment with the new ways of working to deliver your goals.
To understand how the estimand framework changed the development of clinical trials.
Aimed at Statisticians working on the design of Clinical Trials, participants will learn how to use Expected Power, Average Power, Predicted Power, Probability of Success and Assurance, and Bayesian Power when planning clinical trials.
The Apprentice Biostatistician splits their time between working for Parexel and performing studies with a university to obtain a MSc in Statistics over a period of three years.
We are actively looking to expand our team in Wokingham with a permanent position for a Biostatistician / Statistical Programmer.
We are looking for a Principal Statistician to be part of exciting work combing clinical trial data and biomarker data to support the future development of molecules within the therapeutic areas of obesity and NASH.
Biostatistics GLP-1 & CV 1 is seeking statisticians at Specialist and Principal level to be part of the biostatistics team responsible for Novo Nordisk’s large cardiovascular outcomes trials.
The position will be made to match the seniority of the candidate and for the right candidate we offer the opportunity to work mostly homebased from European locations.