Real World data provides information on how people respond to their treatment in everyday life rather than just in clinical trials and is set to play a bigger role in patient access to innovative new medicines.
As the NHS is reformed and budgets tightened, it will become increasingly important for industry to adapt to the evolving relationship with healthcare professionals and further demonstrate the value of its products.
Clinical trials are vital to medicines’ development and provide invaluable data, but they also have limitations. They cover a relatively narrow segment of the population leading to under-representation of some groups including women, children, the very elderly, ethnic minorities and those with multiple co-morbidities.
ABPI Medical and Innovation Director Dr Allison Jeynes-Ellis said:
“These are challenging but exciting times in the world of healthcare and industry must be equipped to adapt and keep pace with this evolution. 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.
“Today’s guide provides a useful reference for members as they look to the future which I believe holds many opportunities, particularly in joint working with the NHS, as well as the obvious challenges.”
The guidance published today provides detailed information on definitions, use and practical issues surrounding the conduct of real world data studies.
Amongst other things, the guide shows how to generate robust real world data; discusses what the internal considerations for undertaking such projects are; and provides a practical checklist.
A copy of the guide and more information can be found on the ABPI website at www.abpi.org.uk/our-work/news/2011/Pages/240511.aspx
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About the ABPI
We represent innovative research-based biopharmaceutical companies, both large and small, leading an exciting new era of biosciences in the UK.
Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. Our members supply 90 per cent of all medicines used by the NHS, and are researching and developing 90 per cent of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome diseases.
We are the Government recognised body negotiating the pricing of branded medicines on behalf of the entire industry. Working with our Research Affiliate Members, we promote the UK as a destination of choice for international life sciences investment.