The use of Centralised Statistical Monitoring and Quality Tolerance Limits are fundamental components of Risk Based Quality Management as laid out in ICH-E6(R2) Good Clinical Practice. However, although there has been much commentary published on the operational application of Central Monitoring & QTLs, there appears to be a gap in the literature for the more detailed statistical methodologies that can be utilized.
The Central Statistical Monitoring / Quality Tolerance Limits - Special Interest Group (CSM SIG) has formed itself to create a forum to collaborate and discuss statistical strategies and methodology by;
If you’re interested in learning more &/or joining the CSM SIG please contact the SIG Co-chairs: Susan Talbot & Tim Rolfe.
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
This webinar consists of three presentations providing examples of where Bayesian methods have been used within confirmatory settings.
We will present the most frequently asked questions in the post-marketing space, the reasons why SATs are not able to address these questions, and how statisticians might reasonably influence decision makers to consider alternatives.
This course will introduce participants to the key concepts and methods relevant for analysing clinical trials when some data are missing.
The meeting will consider the importance of patient-centric input into regulatory and HTA decision-making discussing the latest developments in the field and presenting industry examples.
The next book we are reading is "The 7 Habits of Highly Effective People" by Stephen R. Covey. This is a classic in the personal development genre.
PD Dr. Tölch will present a framework to foster efficient evidence generation in preclinical experiments and will illustrate the proposed approach using examples from various projects. This will be followed by Q&A.
Our speaker will share her experience in extending/innovating methodology and concepts developed in vaccine statistics to the analyses of pre-efficacy and efficacy trials of monoclonal antibodies.
A careers talk about medical statistics and how it plays a crucial role in developing new medicines
Please join us to hear Kristian Brock and Ying Yuan present their recent work for our next Journal Club webinar, as sponsored by Wiley.
This course describes calculations for sample size estimation in the design of clinical trials. It will highlight how the objectives of a clinical trial will impact on sample size calculations. The course is a practical course and all methods will be illustrated with examples and case studies.
In this webinar, you will get to know how an innovative adaptive design can increase the probability of success of your early phase clinical trial as well as hear the latest and greatest of the Machine Learning workstream from the Biomarkers ESIG.
This one-day event will establish a forum to engage with colleagues from a diverse range of backgrounds who are actively working on effective master protocol design, analysis, and execution.
This event is aimed at students with an interest in the field of Medical Statistics, for example within pharmaceuticals, healthcare and/or medical research.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
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.
