Regulator

Real-World Evidence Studies for Regulatory Use Current regulatory use of real-world evidence during drug development

Pharmaceutical companies use real-world evidence studies to collect data from groups that are routinely excluded from randomised controlled trials. This makes real-world evidence a useful supplement.

However, such studies have well-documented limitations, such as having many confounders, which have generally restricted their use to post-approval stages.

Despite this, bodies such as the European Medicines Agency have made research efforts to show that real-world evidence that meets a range of quality criteria is suitable for some pre-approval uses.

Generating real-world evidence studies at the regulatory stage to benefit more patients, more quickly

When pharmaceutical companies provide real-world evidence to regulators, medicines have a better chance of reaching more patients, more quickly. This is because real-world evidence broadens the patient groups considered during engagements, potentially broadening the population indicated.

Currently, pharmaceutical companies are not generating enough real-world evidence for regulatory use. However, our research shows that real-world evidence has, on average, fewer criteria limiting the included population than clinical trial evidence. This made regulators more likely to indicate a broader population than when pharmaceutical companies submitted clinical trial evidence alone.

The Approach

Many diseases and contexts require a specific approach to construct measurement to produce high-quality real-world evidence. This ensures gold standard accuracy in detecting effects when they are present.

Our unique approach ensures the delivery of the right, high-quality evidence to regulators at the earliest opportunity, matching real-world evidence with regulator decision-making needs.

The addition of real-world evidence to randomised clinical trial evidence has the potential to change lives. Medicines could reach 30 more patients for every 100 trial patients, providing treatments to those who may not otherwise receive them. And medicines could reach patients 22 months quicker for every 100 trial months, helping patients get better sooner.

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Medialis is a medical affairs consultancy servicing the pharmaceutical industry. Unlike some other agencies, we are proactive, not reactive or one-dimensional – if you need it, we can do it.

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