Real World Data
With some interest, I have been following the Association of the British Pharmaceutical Industry (ABPI) innovation project looking at ‘Real World Data’. Just this month the ABPI launched its ‘Vision for Real World data’.
One of the key drivers for the ABPIs project team overseeing this project is to better understand and define the value of Real World data – the actual reality in the context of health care delivery (outside of a randomised clinical trial setting) and the impact this could have on decision making about treatment options.
In discussion that Creation Healthcare has had with patient centric organisations such as PatientsLikeMe and CureTogether, they have for some time faced challenges in determining how their ‘real-world’ data sits in the evidence spectrum – particularly in the context of the clinical establishment.
In the following video Allison Jeynes-Ellis, Medical and Innovation Director for the ABPI, introduces the guidance they have issued on the subject, making the point;
“Real world evidence is going to be crucial for success in this area”
Kate Pepperell also speaks in the video to explain that real world data is obtained through normal clinical practice, outside of a clinical trial and may include; data on treatment pathways, NHS resource use, models of service delivery, or real patient and clinical outcomes.
Real World or non-interventional data falls outside the clear definitions and regulations of randomised control clinical trials, and there is no single clear directive at the European Union level.
Therefore it is critical to define how to collect robust data, and this new guidance from ABPI forms a practical ‘how-to’ guide for industry.
There is no doubt that the Internet will play a role in helping to understand the ‘real-world’ context of treatment, and to this end it will be interesting to see how the industry interprets and utilises this new guidance from the ABPI.
- Download the Demonstrating value with Real World data document from the ABPI library
- Press release: ABPI produces guidance to help industry demonstrate value for its products