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Category: Project

Description: Clinical trials play a large role in medical decision-making. Although they are normally preregistered in clinical trial databases, they can still be prone to reporting biases. In this project, we aim to provide a thorough overview of the state of changes to prespecified outcomes, from the first trial registration to the results publication, and spin related to primary outcomes in results publications. We will assess publicly available registry information, including historical records, of a sample of clinical trials conducted in Germany between 2009 and 2017. Specifically, we will determine the extent to which trials show changes of outcomes in the registry entry (within-registration changes), and between the last registry entry before publication and the respective publication. We will assess how changes to the outcome are reported in the respective publication. Additionally, we will look at spin in the reporting of statistically nonsignificant primary outcomes.