Webinar Topic
Understanding the Crisis around the P-Values: Statistical Methods for the 21st Century.
Webinar Date & Time
28 May 2019 from 10:00 AM to 11:30 AM (CEST)
Webinar Overview
In literature there are more and more publications raising concerns about the interpretation and misuse of the p-values, in some cases to support decision-making. This is known as the “reproducibility crisis” and it is a primary concern for the biomedical research and pharmaceutical industry.
The purpose of the webinar is to explain the very meaning of the “reproducibility crisis” and the concerns surrounding the p-value and the hypothesis testing as expressed in the recent articles published by Nature and American Statistician, among other journals.
The ultimate objective is to provide a critical understanding of the ongoing crisis and anticipate changes.
- Does it impact the way all decisions are made within the pharmaceutical industry?
- Are some areas more impacted than others?
- Is it more a concern for early research or for clinical development?
- How are the regulatory authorities reacting to the concerns about p-value?
- What is likely going to happen in the next 10 years with that respect?
- Should you be concerned about this reproducibility crisis?
This informative session will help to evaluate risks and opportunities.
There will be a chance to introduce the value of Bayesian biostatistics and its concepts such as prior, posterior and predictive distributions, through a wide variety of examples covering all the range of activities. The differences with the usual (aka Frequentist) statistics will be explained. The opportunities shifting from the Frequentist to the Bayesian statistics will also be explained (for ex. the use of Bayesian statistics to develop a new treatment for rare or orphan diseases, the use of historical control, of innovative clinical trials. The use of Bayesian statistics for leverage Real World Data (RWD) will also be exemplified. We will show how this is also part of the new Clinical Innovative Design initiative launched by the FDA in March 2018.
In addition, it will be explained that the proper use of prior, posterior and predictive distributions for modeling is way more relevant for the type of reality, constraints and decision-making that is needed in the biopharmaceutical industry. Furthermore, we will demonstrate that it opens new opportunities for the development and quality of new products.
No equation will be used and all concepts will be explained using real case studies in a graphical way, so that non-statisticians may easily approach the concepts and the added values for a riskless decision-making.
Presenters
Dr Bruno Boulanger,
Chief Scientific Officer, PharmaLex Belgium (Belgium).
Lecturer, School of Pharmacy, Université de Liège (Belgium).
After a post-doctorate at the Université Catholique de Louvain (Belgium) and the University of Minnesota (USA) in Statistics applied to simulation of clinical trials, Bruno joined Eli Lilly in Belgium in 1990. Since, he gathered 30 years of experience in several areas of pharmaceutical research and industry, including discovery, toxicology, CMC and early clinical phases. He holds various positions in Europe and in USA. Bruno joined UCB Pharma in 2007 as Director of Exploratory Statistics, contributing in the implementation of model-based drug development strategy and applied Bayesian statistics. Since 2000, Bruno is also Lecturer at the Université of Liège, in the School of Pharmacy, teaching Design of Experiments and Statistics. Since 1998 he organizes and contributes to Non-Clinical Statistics in Europe and, in 2010, he setup the First Applied Bayesian Biostatistics Conference. He is also a USP Expert, member of the Committee of Experts in Statistics since 2010. Bruno has authored or co-authored more than 100 publications in applied statistics.
Attendance Fee
€ 90,- for EUCROF non-members
€ 60,- for EUCROF members
Deadline for registration
27 May 2019
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Confirmation
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