The evaluation of drugs and medical devices has moved into a new era. Randomised clinical trials (RCTs) remain the gold standard for evaluating efficacy and safety, however, their limitations are now widely discussed, leading to patients, healthcare professionals (HCPs), regulators and health systems demanding more. With this in mind, there is an increasing acceptance of and desire for real-world evidence (RWE), to observe how the intervention performs under
the stresses and strains of the real world.
So how do we ensure that HCPs, regulators and patients understand and value data that has been collected outside a clinical trial? How do we help people give this data the credit it deserves?
First, we need to do some expectation-setting – if people continue to look for ‘traditional RCT data’ they will be disappointed with RWE. We need to set up the unique value of RWE and the role it plays in our understanding of the clinical value of the intervention.
Second, we have to be clear when communicating the complexities and uncertainties of RWE – as opposed to RCTs, where trial design restricts variability. Hospital data, pharmacy data, electronic health record data, population-level data, health system-level and user-submitted data are all vulnerable to potential uncertainties and ‘rogue’ data. Being able to discuss the value of collecting all data and the limitations this imposes is part of the challenge. Explaining the enhanced validity of patient-reported outcomes in a real-world setting is a test – these outcomes are likely to shed more light on the impact on a patient’s life than those collected in a controlled setting.
And finally, does the unique types of data collected through real-world studies give us the opportunity to present our data in a novel way? We now live in a world where consumer reviews and ratings of products and services on TripAdvisor, Amazon and Uber are king. Can we take some inspiration from green smiley to red angry faces? Live dashboards are everywhere in our lives now. Could we set these studies up to read out live data rather than waiting 12 months for an analysis?
RWE is here to stay and for medical communicators and healthcare audiences, it’s very exciting. The successful pharma companies will be the ones who can embrace this change and learn to communicate the benefits to all stakeholders in a straightforward and compelling way.
