Debunking the 3 biggest myths about decentralised trials

By now most people reading this will have heard of “decentralised” clinical trials. But despite that, there is still a huge amount of uncertainty as to precisely what this actually means. This article is going to help fix that by debunking the biggest 3 myths about decentralised clinical trials. 

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Myth 1: Decentralised trials just means sending nurses to people’s homes

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No! Despite what some companies might have you believe, decentralising trials covers a huge range of different methodologies. This could mean sending nurses to people’s homes, but it could also mean: 

• Patients doing blood tests at home and posting them to a central lab
• Using ePRO to collect self-reported endpoints
• Working with non-traditional trial sites like in primary care
• Not having a “site” at all and working with someone like Lindus Health who can operate as a fully “virtual” site
  
  

…and a thousand other things. The key thing is that decentralising a trial is just a means to an end to achieve better, faster trial data in a more patient-friendly way. When done properly, decentralised trials can hugely improve speed and reliability of a trial.

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Myth 2: You can only decentralise a trial if there are no physical biomarkers

Again this is just plain wrong. As we touched on above you can definitely collect physical biomarker endpoint data on interventional studies using a decentralised methodology.

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For example, we’re currently running the DiGEST trial for Habitual - working with an amazing Principal Investigator, Prof Carel le Roux. This is a fully remote study evaluating Habitual’s intervention (Total Diet Replacement + Digital app) for reversing Type 2 Diabetes.

For the DiGEST trial, we’re recruiting and screening patients through their primary care provider. Patients can take part entirely from home using at-home blood tests that are processed in gold standard central labs (for Hba1c) and ePRO (for weight and blood pressure).. 

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Myth 3: Retention and adherence on decentralised trials is worse

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So at least this one could be true if a study was poorly designed, but it definitely doesn’t have to be. In fact one of the biggest advantages of a decentralised trial is that it reduces the burden on patients taking part, which we know boosts retention, adherence and overall patient satisfaction. Trial participants are busy people with busy lives, and trials shouldn’t be a burden.

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Decentralised trials can also build strong relationships between site team and participants. We’ve found the most important thing is that participants’ have a personal connection with a named research nurse. The fact that they might only meet on Zoom doesn’t matter - say hello to Cassy below!

Conclusion

Thanks for reading this far! There are a ton of other myths surrounding decentralised trials and other new trial methodologies. If you’re still not sure if a decentralised trial could be right for you, then please get in touch!

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But the best thing about Lindus Health is that we don’t just do decentralised trials. We design every trial to suit your specific objectives and deliver that in the most effective way possible - if that involves decentralisation then great! If not then we can still hugely improve the traditional site experience using our Citrus technology platform and out top-notch Clinops team.

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