PSI Conference Webinar: Florence Nightingale, pigeon holes and mustard seeds: using data to improve health.
In 2020 we celebrate the bicentenary of Florence Nightingale’s birth and the need for statistical and data skills to improve health show no signs of abating. What lessons can we draw from Florence Nightingale to shape the future of statistics?
PSI Conference Webinar: Career Young Statistician Session
PSI presents 4 very different talks from 4 statisticians still lucky enough to be deemed young in their careers. Jack Keeler will speak on enrichment designs with survival data; Ruth Owen on methods to evaluate the benefit-risk trade-off in individual patients; Ines Reis will give a young statistician’s guide to regulatory statistics and Georgios Nikoladis will talk about Borrowing strength from indirect evidence in HTA. A session not to be missed!
Our Impact and the Future Focus of PSI - 2020 PSI AGM
Join us between Conference webinars to also hear about the key achievements from 2019, the impacts and adaptations stemming from COVID-19, and what there is to look forward to with PSI, through 2020 and beyond.
PSI Conference Webinar: In memory of Sally Hollis (former SIG Chair) - 'Data as an Asset, the re-use of data'.
On behalf of the data transparency SIG, 3 speakers give their input on why we must now regard our data as an asset due to data transparency, the essential principles that statisticians need to be aware of regarding clinical data and patient privacy, how data can be re-used responsibly and the work of the Global Digital health unit, which uses real world data to drive precision medicine across the UK healthcare economy.
PSI Conference Webinar: Intersection of Clinical Trials and Real World Data
Christen Gray, Kirsty Hicks and Elizabeth Williamson each speak on their work related to real world data. Topics include Comparing the impact of unmeasured confounding due to selection bias in external comparator studies using RWD, Advanced Analytics of Digital Data: A focus on sensor data, and how we can use RWD to emulate trials.
PSI Conference Webinar: Retire Statistical Significance (!) (?) - How do we know what we know?
Inferring what is likely to be true based statistical analysis of data is a very difficult task and certainly not as easy as computing a p-value for declaring H0 to be true or false based on an arbitrary cut-off value. This session will include the leaders from the two most prominent statistical societies in the world – The RSS (Deborah Ashby) and the ASA (Ron Wasserstein) – and moderated by Stephen Ruberg. Listen to their perspectives and sharpen your statistical thinking.
PSI Conference Webinar: PSI/RSS Prize Winners Session
Listen in to two talks from the 2019 PSI/RSS Prize Winners, Mike Smith and Jacquie Christie. Mike will speak on his thoughts on innovation. What is innovation? How do I innovate? Is it a skill that I can learn or improve on? Jacquie will talk about quantative decision making for clinical development in the work she and Graeme Archer produced which was deemed to be ‘at the cutting edge of revolutionising data driven decision making within the industry’.
PSI Conference Webinar: Impact of COVID-19 to estimands.
This webinar will focus on how the estimand framework can help us to pose and answer clinically relevant questions in the light of the COVID-19 pandemic. The case studies presented will illustrate how pre-specified estimands are impacted by the COVID-19 pandemic, and how methods for estimation including sensitivity analyses may need to be reconsidered to address missing data issues. This session brings together colleagues from the EFPIA/EFSPI estimand implementation working group and the Estimands in Oncology ESIG.
Introduction To Industry Training Course 2020
The ITIT course will take 25 delegates new to the industry on a complete drug development experience from discovery to marketing. They will visit 6 companies from October 2020 to July 2021 to learn about 6 topics from experts in their field. The ITIT course will have 3 sessions in continental Europe and 3 - 4 sessions in the UK. It promises to be a truly memorable course.
A PSI Training Course - R for SAS Users
This course is aimed at Statisticians and Programmers experienced in SAS, but little or no experience with R. An Introduction to R studio and the R language, statistical graphics, programming statistical models, simulations and more…
PSI Toxicology SIG Workshop
PSI Toxicology SIG workshop – 24th and 25th November 2020 The Toxicology SIG provides a forum for statisticians working in regulatory/investigative toxicology, as well as most other pre-clinical areas, to discuss issues and interact with one another. This 1.5-day workshop will involve approximately 20 statisticians, focusing on discussions around “best practice” in the statistical analysis of various data types. The afternoon of Day 1 will include a 4.5 hour Bayesian training course focused towards applications in toxicology/pre-clinical, provided by Prof. Dr. Katja Ickstadt and is included in the workshop fee. The cost will be £270 including VAT per delegate, inclusive of food and one night’s accommodation (and the training course). The workshop is being held at the Crowne Plaza Hotel, Heathrow. The agenda and topics that will be discussed are yet to be finalised, but please get in touch with email@example.com if you have suggestions. Full details will be circulated in the coming weeks.
Special Interest Groups
The Application and Implementation of Methodologies in Statistics (AIMS)
The Benefit-Risk SIG was set up at the start of 2012 to help support those involved in this fast evolving area.
Bridging Data Science knowledge and expertise across various groups and functions within the pharmaceutical industry to increase collaboration, awareness, knowledge sharing and enhance drug development. We’ll encourage the development of new statistical and machine learning methods and approaches as well as in novel applications of the well-established methods.
Sharing experiences and challenges of external patient level data sharing with particular focus on data privacy and anonymization processes.
The Quantitative Decision-making Special Interest Group (QDM SIG) was formed in October 2017. It is a group of statisticians from industry and academia, with experience and interests in statistical methods for quantitative decision-making in drug development.
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 purpose of the Healthcare Technology Assessment SIG is to provide statisticians working in the Pharmaceutical Industry engaged in Health Technology Assessments, and others in related fields of research...
A special interest group to facilitate networking amongst ‘new starters’ (statisticians and programmers) working in medical research - the pharmaceutical industry, Contract Research Organisations and Clinical Trial Units. The group will organise between one and three events per year to achieve this. Networking will be facilitated through three types of event – symposia, development and social.
The draft addendum of the ICH E9 guideline on Statistical Principles for Clinical Trials was released in August 2017 and introduced an estimand framework. In February 2018, Evgeny Degtyarev from Novartis and Kaspar Rufibach from Roche started an informal working group to discuss how to implement the draft addendum in oncological clinical trials.
Subgroup analysis is routinely conducted in drug development, in various settings; one key aspect is the regulatory requirement to demonstrate consistency of treatment effect across a pre-defined set of subgroups (e.g., ICHE5, E9, E17).
To provide a forum to discuss the statistical issues involved in Regulatory and Investigative Toxicology.
Creating a professional platform for statisticians in the Pharmaceutical industry, Regulatory agencies and Public Health organizations working on the research and development of vaccines to understand how best to apply methodologies.
Effective visualisation of data should belong to the core skills of statisticians as it represents an essential tool in exploring data as well as explaining data.