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Real World Data and Evidence

The latest LSG roundtable was all about data. We know data is important, but we want to collect it better. We came up with some answers, and (spoiler alert) Finland plays a major role.

Now you might be thinking: what is Real World Data? It’s capitalized, so it might be worth knowing. We sat down with Real World Data expert and founder of MedEngine Tero Ylisaukko-oja to see what the buzz is all about.

What is Real World Data and why does it matter?

Real World Data is data collected outside traditional clinical trials. It‘s used to demonstrate the clinical and economic value of a product in real-life. Such data is increasingly required by regulators, clinicians and the industry.

Real World Data is needed in both the pre- and post-launch phases of a product. Availability of Real World Data is clearly important for health technology assessments and reimbursement processes. But today, the need is much broader. Companies need to know what the market looks like, how patients are being treated and what the overall costs of the treatment are. This is essential information for the medical, marketing and market access functions throughout the product’s life cycle.

Once the product is on the market, regulatory bodies will typically ask you to collect safety data in the long-term. In the real world – as opposed to clinical trial environments – you have all different kinds of patients: the elderly, patients with more conditions or ailments, and patients taking other medications and receiving additional treatments. Therefore, you are able to find out if there are side-effects that you wouldn’t see in the selected and relatively small population of clinical trials.

It is also important to understand that clinical trials and real world evidence studies are designed differently and carried out for different purposes: “Real World Evidence is essentially an increased understanding of the healthcare costs, treatment practices and real-life clinical outcomes, whereas clinical trials demonstrate the efficacy and safety of the product in a controlled environment. Real World Data answers many questions that are essential from the regulatory, clinical and marketing standpoints,” Tero emphasized.

“Creating such data is not that easy – there are no easy solutions. But once you have the data, your level of insight is totally different,” he concluded.

What role does Finland play?

Finland is the ideal testbed for collecting Real World Data. Amcham member and expert in Real World Evidence Medaffcon reminds us of the reasons why. There are five elements that make Finland “the most advanced testbed in the world.”

How was this determined?

First, the eligible countries were narrowed down to those with biobanks, which included most of the developed world along with several other countries. After that, countries with universal healthcare were looked at. Universal healthcare is helpful in collecting streamlined data.

Next, countries that use unique national identification numbers were identified, which leaves us with Austria, Belgium, Denmark, Estonia, France, Iceland, Norway, the Netherlands, Sweden, Switzerland, and – of course – Finland. Of those, only Iceland and Finland have a genetically isolated enough population to provide significantly insightful data.

Finally, Finland makes data recalling easy. With the research-friendly Biobank Act in conjunction with the use of national identification numbers, accessing, analyzing, and applying data in Finland is easier than ever.

For the world to better collect and utilize data, Finland is the answer. Using Finland as a testbed, Real World Evidence gives us the insights we need to advance healthcare practices all over the world.