Adaptive designs and complex clinical trials offer many well-known advantages throughout the clinical development process and their acceptance is steadily increasing. Typically, such designs use either the Bayesian or the frequent framework for decision making and reporting. While frequentist adaptive designs often have closed-form calculations of operating characteristics, Bayesian designs usually require simulations. On the other hand, Bayesian designs often make it easy to communicate results, incorporate multiple endpoints and achieve efficiency gains by using e.g., the predictive probability for interim decision making. Regardless of the choice of analysis method and the associated philosophical differences in the paradigms, there is an understanding that, among others, frequentist operating characteristics such as power and type 1 error are important to evaluate the proposed design. Ultimately, both Bayesian and frequentist adaptive designs aim to and should be judged by their ability to produce better and more efficient clinical trials without compromising their statistical integrity. In this session, we will bring together experts in the design of both Bayesian and frequentist adaptive trials, as well as a senior European regulator to learn more about recent methodological advances, regulatory considerations, and practical experiences when designing and assessing these trial designs.
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 webinar will show how the estimand framework was applied in a Phase 3 trial in Alzheimer's disease.
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 2-day course is designed to provide a comprehensive understanding of the regulatory guidelines affecting statisticians in the pharmaceutical industry, including the latest updates in the field. The course will cover key International Council for Harmonisation (ICH) guidelines and other key regional regulatory agency documents.
This webinar will discuss opportunities in applying causal inference methodology during the analysis of RCT data.
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.
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 apprenticeship role offers a unique opportunity to learn and work in a global healthcare consultancy company alongside a team of statisticians, psychometricians and programmers.
We have exciting new opportunities available for Study Statisticians, Support Statisticians and Exploratory Statisticians at various levels.
