More complex and demanding protocols are hurting clinical trial performance and success.

For two decades now, companies sponsoring clinical research have openly acknowledged that protocol design negatively impacts clinical trial performance and may well be the single largest source of delays in getting studies completed. But the magnitude of the problem and the challenge of re-engineering how protocols get crafted have squelched the will to attempt a fix. Investigative sites are instead admonished for sluggish enrollment and rising dropout rates.

The real issue is that many patients no longer qualify for or simply lack the stamina to participate in the kinds of studies being rolled out by ...

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