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A Digital Health Expert,

Neurophysiologist & Consultant.

  • Writer's pictureKrutika Gohil

Rethinking Evidence: Drugs & Digital

👇👇 How to Begin Guide 👇👇


Since 2017, there’s been a formal push to regulate digital medicine and therapies like drugs to ensure safety, effectiveness, and evidence-based integration into mainstream healthcare.

Traditionally, the drug evaluations are based on evidence-based healthcare---large-scale RCTs, “gold standard.”, But here’s the twist: they fail to capture the CONTEXT that shape our individual experiences: the broader social, cultural, emotional, intellectual, and environmental factors. Precisely the value and dimension that technology brings to the healthcare- “The well-being and not just health!”

So, testing digital with a methodology which cannot capture its full value is like judging a book by its cover. And this is problematic because this excludes many real-world patients and overlooks crucial contextual factors affecting adherence and long-term effects. So, we end up having an incomplete or even worse, misleading picture of the true effectiveness and safety. This not only stifles the innovation by discouraging investment in promising therapies that may perform better in real-world settings than in tightly controlled trials, but also leads to suboptimal patient outcomes if treatments are approved or rejected based on RCT results that don't reflect their actual performance in diverse populations.

We’re all on a learning curve and trying to find best practices to show our commitment to clinical outcomes and evidence that back our solutions up.

So, lets chat how to best approach this! Happy to share the challenges we have experienced and learn about yours.


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