In the above video Allison Jeynes-Ellis, Medical and Innovation Director at the ABPI and Kate Peperell, Director pH Associates Ltd, talk about the new Real World data guidance document.
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.
Real Word Data Guidance
Allison Jeynes-Ellis, Medical and Innovation Director, ABPI
Kate Peperell, Director, pH Associates Ltd
Hi I’m Allison Jeynes-Ellis, Medical and Innovation Director, ABPI. Over the last couple of years the ABPI Innovation Board has been focusing on key campaigns, looking at the research and development lifecycle and seeing areas where we strongly believe the UK could have a competitive edge or indeed be a world leader. The campaign I’m talking about today is Real World Data, as we launch our Real World Data Guidance document.
So what is real world data? What we’re talking about is the use of a medicine in its normal clinical setting outside of a randomised clinical trial. Why is this important and who is it important to? It’s important clearly to the patient themselves, to the doctor, to the payer, the regulator and the NHS. As the NHS embarks on the white paper looking at outcomes and quality then again real world evidence is going to be crucial for success in this area. As we embark on value-based pricing, again, evidence from real world data will be used to make decisions about how innovative new medicines are used and given to patients. Therefore at this point I’d like to hand over to Kate Peperell, who was the lead on the campaign and can tell you much more about what’s actually in the guidance document.
Hi, I’m Kate Peperell and I’ve responsible for leading the Real World Data campaign on behalf of the ABPI. As Allison says, real world data is data on what’s happening every day in normal clinical practice, this is data that’s been collected without any change in treatment, randomisation or any additional procedures or diagnostics. This therefore reflects what’s happening in normal clinical practice outside of a clinical trial. It can include data on treatment pathways, NHS resource use, models of service delivery or real patient or clinical outcomes. It can be captured for a variety of reasons: to improve the evidence base for technology assessment, to capture early clinical experience or more formally evaluate NHS joint working projects.
However, the challenge for all of us working in this area is that whilst there are clear definitions and regulations around randomised control clinical trials, real world data, non-interventional data, falls outside of these. Real world data is used as a term loosely, and there is no single clear directive, such as the EU directive that covers the regulations around it. With its increasing importance it’s absolutely critical that the industry generate quality, robust data, and to this end the guide is there to try and support this need.
This guide has been written for those who may simply need a reference guide, such as colleagues in regulatory, legal and governance roles, but also as a real practical how-to guide for those charged with design and implementation. Its main purpose is to provide clarity about what is meant by real-world data, how it can be used and some of the practical issues that arise when undertaking real world projects. It discusses key issues such as patient consent, the need for ethics and R&D approvals, all complicated practical issues that face us all. We’ve tried to keep it really practical with simple tips on how to generate this type of data, ending with a checklist as an aide-memoir to those engaged with data collection at the coal-face.
We hope you will use the guidance document, will find it useful and relevant and within your organisation you’ll ensure that real world data studies are placed within the UK so that we will indeed become a world leader in this area.
For more information visit www.abpi.org.uk