Several quantitative methodologies have been proposed to support decision-making in drug development. In particular, MultiCriteria Decision Analysis (MCDA) is a useful tool to assess the benefit-risk balance of medicines according to the performances of the treatments on several criteria, accounting for the preferences of the decision-makers regarding the relative importance of these criteria. The EMA Benefit-Risk Methodology Project suggested that it is one of the most comprehensive among the quantitative methodologies they considered, and it is also recommended by several highly profiled expert groups. While MCDA requires the exact elicitation of the weights of the criteria according to the preferences of the decision-makers, extended versions of MCDA have been proposed, such as Stochastic Multicriteria Acceptability Analysis (SMAA) and Dirichlet SMAA, where the weights are considered as random variables to account for some uncertainty in the weight assignment.
This webinar proposes a very concrete illustration of MCDA and of the extended models SMAA and Dirichlet SMAA using case-studies. We will present how to derive a benefit-risk utility score for each treatment, how to compare several treatments, how to present the results and how to conduct sensitivity analyses. The differences between the models will be highlighted, and some R code will be presented and shared after the presentation.
About the Presenter: Gaelle Saint-Hilary
Gaelle Saint-Hilary works in statistics for the pharmaceutical industry since 2006. She is currently completing a PhD on “Quantitative Decision-Making in Drug Development”, sponsored by Servier, at the Polytechnic University of Turin (Italy). Before that, she worked as biostatistician in the industry, first at Servier for 5 years and then at Novartis Oncology for 4 years. She was responsible for the clinical development and the licensing of medicinal products in neuropsychiatry and leukemia, and her main scientific interests were benefit-risk assessment, network meta-analyses, multiple test procedures, simulation models of time-to-event data and survival analysis in presence of intercurrent events. The development and the promotion of quantitative methods for drug benefit-risk assessments is one of the major topics she considers during her PhD, with the final goal of enhancing decision-making throughout the drug life-cycle.
About the Presenter: Stephanie Cadour
Graduated in 2011, Stéphanie Cadour works as a biostatistician at Servier (France) since then. She was initially responsible for the statistical aspects of phase II and III clinical studies conducted in the therapeutic areas of neuropsychiatry and diabetes. She is now working on early phase studies in the field of oncology. In parallel of these activities, Stephanie developed skills on meta-analyses as well as on quantitative approaches for benefit-risk assessment on which she has been working on since 2011.
An opportunity to meet statisticians from across the pharmaceutical industry in a relaxed and informal setting. An exciting program of events and a chance to work in small groups on a data analysis challenge. Lunch provided.
A Non-PSI Event - Protecting confidentiality and privacy in clinical trial and medical data sets
We are increasingly living in a data driven world. Data are collected in many different ways for a variety of purposes. As such, concerns around protecting the privacy of individuals have increased in recent times.
A PSI Training Course - Practical Approaches to Designing Adaptive Clinical Trials
This hands-on course will provide a deep dive into 4 software packages used to design adaptive clinical trials.
The course will start by providing a general overview of adaptive designs, explaining the different type of adaptations possible and the benefits of each design. Following this, participants will be given the opportunity to have a go at designing trials in R (using RPACTS), EAST, FACTS, and nQuery.
PSI Training Course - Bayesian Practical Course using R and SAS
This practical training course will give a deep dive into performing Bayesian analyses in R and SAS. It is aimed at statisticians who need to be able to conduct Bayesian analyses as part of their day to day work. By the end of the course participants will be able to conduct their own analyses.
This webinar will address operational issues of paramount importance within the healthcare industry with a view to using statistics for the benefit of patients. In attending this webinar, you'll hear more about work being conducted to address some operational issues we face in the health care industrys e.g. patient rectuitment, drug supply and meeting NHS 18 week targets.
PSI Toxicology SIG workshop – 16th and 17th March 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 firstname.lastname@example.org if you have suggestions. Full details will be circulated in the coming weeks.
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…
Non-proportional hazards and applications in immuno-oncology
Designs of clinical trials with time to event primary endpoints usually rely on hazards being constant over time. A major challenge in immuno-oncology is the delayed onset of benefit with such therapies and the presence of non-proportional hazards. The impact of this needs to be accounted for in sample size calculations, analysis methodology and reporting. At this meeting, we will examine possible strategies to handle such features, which may not be fully known when the trial is initiated.
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 6 sessions in continental Europe and 3 - 4 sessions in the UK. It promises to be a truly memorable course.