Clinical Trial Podcast | Conversations with Clinical Research Experts cover image

Human-centered design role in clinical trials with Bruce Hellman and Ben James

Clinical Trial Podcast | Conversations with Clinical Research Experts

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What Are E.Co.I and E.Protech?

Some listeners may be less familiar with the E.Co.I and E.Protech terminology. So maybe can we just start with some basic definitions of what those two words mean like the clinical outcome assessment and patient reported outcomes. What are they and why are they important? Yeah, it's a good starting point. The data is absolutely essential to capture. It can often form the primary endpoint of a clinical trial. For a new drug, over half of new drugs being approved by the FDA have patient reported outcome data in the filing. And an increasing number of HDAs and sort of pricing reimbursement filings also have patient reports as part of that data package.

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