Randomised controlled trials are tidy, logical, and beloved by regulators. But once a product leaves the pristine world of trial centres and meets real patients, the picture changes. Real-world evidence (RWE) decides whether a therapy’s promise holds up under pressure — or unravels.
The problem is that many companies treat RWE as an afterthought. They tell themselves they’ll “collect real-world data later”. But by the time “later” arrives, payer opinions are already formed. If the real-world story doesn’t match the trial narrative, scepticism spreads fast.
RWE answers the questions that trials can’t. Does the therapy work in older patients with multiple conditions? Do adherence and persistence hold up in daily life? Does it save the health system money once logistics, monitoring, and side effects are factored in? These are the questions payers actually ask.
In oncology and rare diseases, many promising therapies have stumbled because RWE told a less flattering story. Others, initially overlooked, gained momentum through honest, transparent real-world data that proved their worth.
The best approach is to plan RWE alongside your pivotal studies. Build pragmatic trial designs. Partner with health systems early so data collection starts at launch, not two years later. Most importantly, publish all findings, not just the ones that look impressive. Credibility depends on transparency.
Real-world evidence isn’t about compliance. It’s about confidence. When you embrace it early, it becomes your ally rather than your defence.
Key Takeaways
- Plan RWE generation alongside your clinical trials, not after launch.
- Focus on payer-relevant outcomes such as adherence, resource use, and quality of life.
- Work with health systems early to capture real data from day one.
- Publish openly, even when results are mixed — honesty builds trust.
- Remember: real-world credibility drives long-term adoption far more than perfect trials do.
