Registration quality and availability of publications for clinical trials in Germany and the influence of structural factors

Abstract

Introduction Analyses of clinical trial registries (CTRs) offer insights into methodological problems of published research studies, e.g., non-publication and outcome-switching. Here, we use CTRs as a tool to evaluate clinical studies conducted in Germany and test how their registration quality is associated with time and structural factors: Coordinating Centers for Clinical Trials (KKS) and Universities of Excellence. Methods We searched ClinicalTrials.gov, the DRKS, and the ICTRP for clinical trials recruiting participants in Germany. As a measure for the methodological quality, we assessed the proportion of trials that were pre-registered. In addition, the registration quality and availability of publications relating to the trials were manually assessed for a sample (n = 639). Also, the influence of the structural factors was tested using regression models. Results We identified 35,912 trials that were conducted in Germany. 59% of trials were pre-registered. Surprisingly, Universities of Excellence had lower pre-registration rates. The influence of KKS was unclear and also difficult to test. Interventional trials were more likely to be pre-registered. Registration quality improved over time and was higher in interventional trials. As of early 2021, 49% of trials that started until the end of 2015 have published scientific articles. 187 of 502 studies on ClinicalTrials.gov for which we found published articles did not reference any in the registry entry. Discussion The structural predictors did not show consistent relationships with the various outcome variables. However, the finding that the study type and time were related to better registration quality suggests that regulatory regimes may have an impact. Limitations of this non-pre-registered study were that no modifications to registry entries were tracked and the coarse measure of KKS involvement.