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Best practices for designing patient-centric decentralized clinical trials

By Jess Fowler, Todd Johnson, and John Ferraro, Clinical Leader

Decentralized trials, hybrid trials, and agile trials — these are all a few broad modifications to the standard brick-and-mortar clinical trials we’ve been accustomed to since COVID-19 changed the standard of clinical operations. Now that our industry has become familiar with flexible design, we’ve noticed the discussion points on these designs continue to stay high-level, relegated to more broad-spectrum adjustments. But at what cost?

We’ve noticed the downside of keeping the conversation broad is a disconnect on the applicability of decentralized and hybrid trials across therapeutic areas. It’s critical to understand that each clinical trial is truly unique — just like each patient — and not all decentralized or hybrid design elements will be applicable across trials. Understanding the bigger picture requires slowing down to take more time to gather the necessary patient feedback that’s essential in the planning process.

This is why we want to home in on a few therapeutic areas and share our observations and recommendations to highlight examples that may bring decentralized and hybrid trials to a more tangible and realistic view and, in essence, make them more executable. Read more …