Clinical Trials Thesis Dataset

Background: The aim of this study was to examine if eligible trials registered on ClinicalTrials.gov provided data sharing statements and if they did to what extent did the data sharing statements fulfil the International Committee of Medical Journal Editors (ICMJE). Methods: This is a retrospective study of publicly available data with results analysed using descriptive statistics. Results: 41% of studies (n=135) said ‘No’ to the ‘Intentions to Share IPD’ question on ClinicalTrials.gov, 27% (N = 90) answered ‘Yes’, 27% (n = 88) left the question blank and 5% (n = 16) have answered ‘Undecided’. None of the studies that answered ‘No’ or ‘Undecided’ have provided reasons why. Out of the 90 studies that answered ‘Yes’ to intentions to share IPD, 3 studies have answered ‘Yes’ but have not provided a DSS or IPD sharing plan. Conclusions: Despite the International Committee of Medical Journal Editors (ICMJE) guidelines strongly encouraged since 2018, many sponsors still do not follow the guidelines and do not provide any reasons as to why. This can have potentially negative implications and result in, for example, deceleration of advancement of medical research and waste of time and resources on research that has already been performed.