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TREND 7: Protocol Design Will Triumph Over the Document

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If you have heard me talk about protocol design, you would be forgiven for thinking I hate Microsoft Word; I promise that isn’t the case! Word documents are great for capturing information that you might want to go back and read one day, but they are a terrible place to capture information that should be analyzed, challenged and then used in many different documents and systems.

In 2011, we saw the start of a shift from focusing on protocol authoring to thinking about protocol design. I believe we’ll see that thinking become mainstream practice in 2012.

What do I mean by focusing on protocol design? I mean looking just at the core science of the study: the eligibility criteria, objectives, endpoints and data collected in the schedule of activities, and looking at it outside of a document environment. By capturing the clinical concepts in a structured way, it is possible to define relationships between them (e.g., blood pressure at visit two is being collected to support a safety endpoint that is connected to the primary objective for my study) and then to analyze the design to ensure it is optimized. It is also imperative that the impacts of decisions to include endpoints or procedures are understood in terms of the impacts on cost, complexity and patient tolerability of the study.

Structuring clinical concepts and design-focused protocol development practices are going to lead to sponsor organizations being able to better develop and manage their clinical programs, ensuring that as much importance is placed on well designed studies as is currently placed on the formatting of the document itself!

There are many other advantages of design centric structured protocol development, and I’m looking forward to discussing them more with you in future blog posts.

More about Michelle Marlborough

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