Harmonization Of Global Data: Bridging The Gaps Among Local Registries

Over the past two decades, there has been significant development in the realm of clinical trial disclosure, particularly since the inception of ClinicalTrials.gov in 2000 by the United States. Initially hosting a modest 1,255 registered trials in its debut year, ClinicalTrials.gov has since expanded dramatically, now accommodating a staggering 473,067 registered trials. This expansion reflects a global trend, with many countries worldwide establishing their own clinical trial registries. Notably, the International Committee of Medical Journal Editors (ICMJE) mandates trial registration for publication consideration, further emphasizing the importance of these registries.

Currently, over 79 countries are enforcing clinical trial disclosure requirements, including 31 adhering to European Union (EU) standards. Moreover, there are 40 countries with at least one dedicated clinical trial registry, alongside regional registries like CTIS, PACTR, and ISRCTN. Despite this growth, challenges arise in the submission of multinational trial data due to varying data standards and requirements across different registries. This discrepancy often results in data inconsistencies among registries.

A systematic review analyzing 197 randomized clinical trials registered across multiple registries revealed that while sponsors and funders exhibited a high level of agreement among registries, agreement levels declined concerning other data points. This underscores the need for greater consistency and standardization in data submission practices across registries to mitigate discrepancies and enhance transparency in clinical trial disclosure.