ABPI 'real world' value guidance

The UK's Association of the British Pharmaceutical Industry (ABPI) has published guidance on the use of data from real life situations, rather than an experimental environment, to demonstrate the value of a product.

The trade organisation explained that 'real world' data is important in providing information on how patients respond to treatment in an everyday setting, and is set to become a bigger part of providing access to new medicines.

"These are challenging but exciting times in the world of healthcare and industry must be equipped to adapt and keep pace with this evolution," said ABPI medical and innovation director Dr Allison Jeynes-Ellis.

"A survey of our members showed a real appetite for guidance on how best to use real world data to prove the value of innovative new medicines – something which has always been important but is even more critical now in these tough economic times."

The guidance provides information on definitions, use and practical issues surrounding the conduct of real world data studies. How to generate real world data and a practical checklist are also included in the guide.

The ABPI has Demonstrating value with real world data available to download.

The ABPI has produced a video explaining the importance of such data, as well as how the body's guidance can be used: