PSI Journal Club: Limitations and Challenges with Mixed Model Repeated Measures (MMRM) Analysis
Moses Mwangi and Florian Lasch present their recent work on MMRM, with discussion lead by Geert Molenberghs.
Our last event of 2015, sponsored by Wiley, was held in mid-December 2015, on the topic of Go/NoGo Decision Rules and Probability of Program Success. We were pleased to coordinate with the DIA for this event, with speakers from Pharmaceutical Statistics and Therapeutic Innovation & Regulatory Science. Listen again or catch up on the event here.
DIA Chair: Tad Archambault, Virtu Stat, Ltd.
Speaker: Ming Zhou, Amylin Pharmaceuticals
A Novel Design for Decision Rules Based on Statistical Testing Strategies of Binary Endpoints in a Definitive Go/No-Go Single-Treatment Clinical Study
Authors: Ming Zhou and Larry Z. Shen
Therapeutic Innovation & Regulatory Science, Vol. 48, Issue 3, pp. 327-335, 2014
Links: Abstract | Paper+ | Slides
PSI Chair: Sarah Bray, Amgen
Speaker: Meihua Wang, Merck Research Laboratories
Evaluation of program success for programs with multiple trials in binary outcomes
Authors: Meihua Wang, G. Frank Liu, and Jerald Schindler
Pharmaceutical Statistics, Vol. 14, Issue 3, pp. 172–179, 2015
Links: Abstract | Paper+ | Slides
Discussant: Fanhui Kong, FDA
+Papers available to view from December 8th 2015 to January 5th 2016.
For the flier advertising the event, please click here.
Moses Mwangi and Florian Lasch present their recent work on MMRM, with discussion lead by Geert Molenberghs.
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.
Talks from speakers will cover an introduction to HTA and indirect comparisons for value assessment before focusing in more specifically on topics related to the use of indirect treatment comparisons for patient access.
Talks from the speakers will cover the use of R in a programming community, submitted to regulators using R, and also programming beyond R in C++ and Julia.
This course is aimed at clinical trial statisticians who are new to or with limited experience of machine learning. Attendees will learn about a range of topics in machine learning, including practical sessions in R.
This webinar will explore two different approaches to Correlates of Protection in vaccine development.
The event will open with an overview on drug development in women’s health from a clinician perspective. This talk is followed by talks about statistical challenges when planning IVF studies and analysing the menstrual cycles.
This webinar will provide an overview of surrogacy for licensing and reimbursement. In turn, the need of extensions of the SPIRIT and CONSORT statement will be defined and outlined, with case studies to support.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.