This guidance provides further clarity around the definitions and use of Real-World Data (RWD) and Real-World-Evidence (RWE) in the over-the-counter (OTC) sector in the UK, based on the different OTC product lifecycle stages.
It also provides a simple guidance and identifies key common elements that need defining while in early phases of a real world project study design.
This guidance covers:
- Generating RWE from RWD
- Applications of RWD and RWE across the product lifestyle
- Practical guidance on conducting Real-World studies
