Why do we have a Data Sharing ESIG?
Clinical data has greater use beyond the original trial. These data can be used to further increase our scientific understanding of diseases and their treatment for the benefit of future patients. Dataset re-use is increasingly becoming part of good trial practice e.g. use of historical control arm data for planning, adding together the findings from many trials, and doing methodology work to improve the way we do future trials. Alongside this, clinical trial documents are increasingly required to be open to access to the public within the regulatory framework (e.g. EMA Policy 70, EU CTR). All this is challenging, as both the data privacy and the regulatory framework continue to evolve.
Who are we?
This ESIG comprises statisticians (both from pharma and academia) and some policy experts who are working or have interest in the data re-use, data privacy and data sharing space.
What’s our purpose?
1. Promote an understanding of the challenges and responsibility organisations and statisticians have when re-using or sharing clinical data.
2. Improve understanding, implementation and data privacy concepts within the context of clinical trial data sharing.
3. Influence and shape the environment and policies regarding clinical data sharing.
4. Collaborate with other groups and stakeholders in this area.
Want to know more?
Check out the resources we have on our ESIG page.
Would you like to join us?
New members are welcome! If you’re interested in finding out more please contact Rebecca Sudlow or Mimmi Sundler for further information.
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 webinar will cover the history of cell/gene therapy, major regulatory advances, the role of quantitative scientists in drug development of these novel therapeutics, and discuss opportunities for innovation and product advancement.
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.
