RWE data are an increasingly valuable resource in drug development. One area where this data is being used regularly is in the generalisability of treatment comparisons. This event will focus on this topic and more specifically on new advances in indirect comparisons, generalizability approaches for clinical trial data into the real world setting and cross-design approaches combining observational and randomized data.

This is a 1-day course, aimed to introduce statistics to people who work on Clinical Trials, but who are not Statisticians. No previous knowledge of Statistics is assumed as we start right at the beginning with the basics. Many practical examples are given and the emphasis is on application and understanding rather than the equations and the technical background.

The course objective is to inform statisticians about the likely interactions they might have with regulatory agencies, both during a submission and at other times during drug development, and give advice on how to make these interactions most effective.

The aim of the workshop is to translate and promote novel methodologies developed by IDEAS and is geared towards statisticians and trialists with an interest in novel methods for early phase clinical trials. Therefore, it will be of interest to those working in academia, industry, HTA or regulatory authorities.

AIM: To describe the drug development process from research right through to research, toxicology, data management & role of the CRO, clinical trials, product development & manufacture and marketing.