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When Clinical Trials Meet the Real World


The biopharma industry faces a troubling problem: Trial design is foundering on multiple fronts. About 64 percent of phase three trials fail, and about two thirds of these failures occur due to flawed design, inappropriate endpoints or under-enrollment. Even when trials don’t fail, they incur on average 1.5 institutional review board (IRB) amendments per trial, costing roughly $500,000 each and potentially delaying trials for months. Many biopharma companies do not fully embed value in their clinical development programs, and struggle with achieving uptake or demonstrating the value of the new therapies they’ve worked so hard to develop. That’s because real world patients often look very different from trial patients, or because the clinical guidelines don’t match up with the new therapies. When drugs work in the lab, but not out in the real world, doctors don’t want to prescribe them and patients don’t want to take them.

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