The need for a uniform database for real-world evidence and data
Roche pleads for open dialogue in the healthcare sector
Ever heard of ‘real-world evidence & data’? The healthcare sector is attaching more and more importance to this kind of information on medication use. Particularly in the field of oncology, where quite a few innovative medicines are brought to the market at a fast pace. The search for a uniform, easy and standardised way to collect relevant real-world data is a challenge. Together with our Chair Partner Roche, we are happy to put our shoulders to the wheel within the research field of the Vlerick Healthcare Management Centre.
‘The difference between results from clinical trials and real-world evidence & data is that real-world evidence & data come from everyday practice,’ Tijl De Celle, Market Access Manager at Roche starts. ‘We are talking about patients’ medical information recorded during the treatment of a particular illness, for instance. Or the type of medicine and doses the patient takes of this medicine. In contrast, a clinical trial is a highly controlled situation. A strict study protocol is followed and the participants have to meet stringent criteria. The protocol outlines points such as which patients qualify for the trial (cancer type, medical history, etc.). It also includes the treatment schedule (e.g. dosage of the medicine), the studies that are tracking the patients and the frequency thereof (e.g. type and time of blood tests).’
Tijl De Celle, Market Access Manager at Roche: ‘The difference between results from clinical trials and real-world evidence & data is that real-world evidence & data come from everyday practice.’
Complementary to clinical trials
Why are real-world evidence & data so important? ‘Real-world evidence & data are complementary to clinical trials. Because this is information you can’t collect via a trial,’ according to Myriam Nechelput, Market Access Director at Roche. ‘For instance, data on the amount of medication a patient takes in a particular period of time or the duration of the treatment.’ All parties in the healthcare sector have now also come to understand the importance of real-world evidence & data. Because all parties involved can use this information in their decision-making process. For instance, when making a decision on the refunding of a new medicine.
Myriam Nechelput, Market Access Director at Roche: ‘More and more parties have come to understand the importance of real-world evidence & data.’
Call for a single, uniform system
As more players are seeing the importance of these concrete data, more real-world evidence & data are also being recorded. ‘The biggest challenge today is to find a single, uniform system to collect all these data structurally,’ says Tijl. ‘A user-friendly, flexible system that can be adapted quickly to the treatment or illness. Currently, there are many different, separate recording systems. For instance, doctors make notes in the files of their patients and RIZIV (National Institute for Health and Disability Insurance) introduced an electronic system for the refund application of certain medicines.’ Retrieving the relevant real-world evidence & data for the treatment of a particular illness is not straightforward.
User-friendly, relevant and of high quality
‘We want to move towards one national, standardised system that is recognised, accepted and systematically used by all parties involved. For doctors, such a system should be convenient and simple to use and should preferably not entail extra administrative work. What’s more, the data have to be relevant and of high quality. The privacy of patients must, of course, also be protected. So it goes without saying that all patient data should be anonymous and properly secured.’
Tijl De Celle: ‘We want to move towards one national, standardised system that is recognised, accepted and systematically used by all parties involved.’
The key to bringing about this kind of uniform system is an open dialogue with all players in the healthcare sector. Myriam: ‘The workshop we organised together with Vlerick early this year is a step in this direction. It showed that, currently, considerable efforts are already being made to collect high-quality real-world evidence & data. All parties involved were also very enthusiastic about taking part. This, in itself, is proof that everyone understands the importance of real-world evidence & data and the need for an efficient system to collect these data.’ So it is vital to keep the dialogue going. ‘Only then will we optimise the collection and ultimately also the quality of our real-world evidence & data. And that’s what we want!’
Myriam Nechelput: ‘An open dialogue with one another is the key to a uniform system for real-world evidence & data.’
Workshop: Views on real-world evidence
Early this year, on Tuesday 23 February, we organised the workshop ‘Opportunities and Challenges for RWD/RWE-enabled Market Entry Agreements in Belgium’ together with Roche. The workshop was attended by key parties from the healthcare sector, in total about 40 people. It opened with the views on real-world evidence & data of a number of parties involved. The day ended with a panel discussion, led by Professor Walter Van Dyck.