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Considerable quality investments over the past decade have had little demonstrable impact on clinical trial performance and quality.
Considerable quality investments over the past decade have had little demonstrable impact on clinical trial performance and quality. The premise of this study is that a major reason for this is because we are not measuring the quality and performance of clinical trials properly. Instead, the industry has been using operational metrics better suited to measure manufacturing quality. In this paper, we apply a paradigm widely adopted in other service industries to illustrate how to identify the key performance drivers that drive conduct quality.
The results of this study at times complement conventional wisdom, but at times contradict it. The performance drivers that have, for example, the greatest impact on conduct quality are project manager performance and managing site relations. Meeting enrollment timelines and the adaptability of the study team had lesser but positive effects on conduct quality. Surprisingly, routine monitoring visits had a negative impact on conduct quality.
The results of this study illustrate a fresh approach to assessing clinical trial quality that has the potential to not only meet regulatory requirements, but also improve the ability to meet trial budges and deadlines through improved trial quality. Prioritizing quality – as opposed to a focus on operational metrics, is new to the industry and these findings will allow managers to improve the monitoring and oversight of clinical trials while maximizing the ROI on clinical trial quality investments.