A Comparison of the Quality of Data, Assessed Using Query Rates, From Clinical Trials Conducted Across Developed Versus Emerging Global Regions

Abstract

With increasing globalization of clinical trials, there is a growing concern regarding the quality of data generated from clinical studies conducted in some of the emerging regions. This concern has not been comprehensively addressed thus far because there is limited public access to restricted databases. In this study, we utilized data from 26 large phase II/III trials conducted in multiple regions of the globe by members of the Association of Clinical Research Organization and compared query rates, one of the few measurable parameters of quality of clinical trials data, between different global regions. A query is generated when a discrepancy is noted between protocol or source data and the case report forms (CRFs). A resolution of such an inconsistency is necessitated, which may result in a database change. The studies included in our analyses were conducted at 4721 global sites enrolling 63,871 participants. Overall, the data set included 1.39 million queries, 7.5 million CRF pages, and 95 million data parameters. The number of queries for various regions was added for each trial and normalized to the number of CRF pages or to the number of CRF data parameters. The calculated mean query rates and database change rates were compared using parametric and nonparametric statistical approaches. None of these approaches revealed statistically significant differences in the query rates or the rate of database change when each region was compared to North America or Western Europe. Thus, a comparative assessment of query rates suggests that the quality of clinical trials conducted in emerging countries is consistent with those conducted in developed regions. Despite several limitations of our analyses and the multifaceted complexities of global clinical trials, our findings should alleviate some concerns regarding clinical studies conducted in emerging nations.