The confidentiality of interim results of on-going trials is a topic on the agenda of the EMA Biostatistics Working Party (BSWP). ICH E9 states that all staff at the investigational sites and at sponsor (except those directly involved with the execution of an interim analysis) should remain blinded to any interim analysis results. The BSWP recognised that this advice may need to be re-evaluated, especially for some complex situations (eg the use of interim analyses in Cardiovascular Outcomes Trials to rule out harm or for gene therapy where the full results may not be available for 15 years).
The BSWP therefore asked the PSI/EFSPI Regulatory Committee to set up a PSI/EFSPI expert working group on this topic and to provide thoughts and recommendations. The expert working group has been formed under the leadership of Jürgen Hummel (PPD), Erika Daly (ICON) and Robin Mukherjee (Astra Zeneca), and are planning to meet face to face on 11 May with the aim to get back to the BSWP by September 2017.
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.
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.
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.
Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.
We will share a brief overview of what Mobilise D is and why it is an important step stone in the development of digital biomarkers, and how Mobilise D outputs can be relevant for you.
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.
We have exciting new opportunities available for Study Statisticians, Support Statisticians and Exploratory Statisticians at various levels.
