Challenge #5: Keep the study on track, even in unknown territory

Around here, even breaking new ground can be an old story

A challenge in rare disease studies is that they often don’t resemble the vast majority of studies we all use for setting expectations. There may be almost nothing in the literature — no benchmarking data, no standardized trial designs.

Often we have to change the scope of the project midstream — adding sites, changing sites, adjusting protocols — and that means being creative and flexible. It also means planning for the unexpected, and even planning for being wrong.

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