Applied Clinical Trials
For all the promises of the impact of technology on clinical trials-from enhanced trial efficiencies to reduced time to market-very few specific examples have been published that clearly demonstrate a marked impact. This article provides just such an example, by examining the impact of electronic diaries (eDiaries) on the collection of Patient Reported Outcome (PRO) data in a large, pivotal Phase III trial evaluating a medication for the treatment of overactive bladder (OAB). We compare the results obtained using eDiaries to capture real-time data on voluntary and involuntary micturitions with those obtained from a Phase II trial that used paper diaries. The result: measurable subject protocol compliance and significantly reduced error variance, yielding increased study sensitivity and the opportunity to realize a significant financial savings in future trials.