The Association of the British Pharmaceutical Industry has today published guidance on the use of Real World data to help industry demonstrate value and provide important medicine response information on under-represented groups of patients.
23 May 2011 Posted in News Release By Press Office
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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