Real-world data (RWD) is an extraordinary resource that is increasingly available to provide useful information to guide development of a new product, to understand characteristics of the diseases, to identify needs of caregivers and patients, and to assess the clinical value of a health technology or medical procedure under 'real-world' conditions. Increasingly, RWD are being used to support regulatory or health economic decisions.
In this context, observational clinical research methods are the main tool for collecting RWD and generating Real World Evidence (RWE). However, due to their complexity, the variety of study designs and the lack of clear regulations, observational clinical studies often lead to lower than expected results or encounter serious difficulties in their regular conduct, with increased costs and time.
The aim of this course is to provide the basic knowledge needed to conduct RWE using observational clinical methods. Therefore, there will be ample time devoted to topics such as:
- the observational method and its main study designs
- what to expect and what not to expect from a real world study
- when and why to use the observational method in pre- and post-marketing product development, using a multidisciplinary approach
- the main sources of real world in the digital health era
- what regulations impact on real world and how to address the challenges they pose
- How to organise and conduct an observational clinical study.