Results dissemination from clinical trials conducted at German university medical centres was delayed and incomplete

Abstract

ObjectiveTimely and comprehensive reporting of clinical trial results build the backbone of evidence-based medicine and responsible research. The proportion of timely disseminated trial results can inform alternative national and international benchmarking of university medical centers (UMCs).Study Design and SettingFor all German UMCs we tracked all registered trials completed between 2009 and 2013. The results and an interactive website benchmark German UMCs regarding their performance in results dissemination.ResultsWe identified and tracked 2,132 clinical trials. For 1,509 trials, one of the German UMCs took the academic lead. Of these 1,509 “lead trials”, 39% published their results (mostly via journal publications) in a timely manner (<24 months after completion). More than six years after study completion, 26% of all eligible lead trials still had not disseminated results.ConclusionDespite substantial attention from many stakeholders to the topic, there is still a strong delay or even absence of results dissemination for many trials. German UMCs have several opportunities to improve this situation. Further research should evaluate whether and how a transparent benchmarking of UMC performance in results dissemination helps to increase value and reduce waste in medical research.

Investigator initiated trials versus industry sponsored trials - translation of randomized controlled trials into clinical practice (IMPACT)

“…Results in registries were also considered in a recently published project that investigated the publication proportion of trials conducted at German university medical centers. Also in this project, a publication proportion of 83% for completed trials could be shown [ 38 ]. Subgroup analyses of this project also confirmed our results, that larger trials are more often published than smaller trials.…”

Results reporting for clinical trials led by medical universities and university hospitals in the Nordic countries was often missing or delayed

“…We automatically excluded observational studies and duplicated entries and identified the sample with a search string for medical universities and university hospitals (Appendix Table 3). We adapted code from the IntoValue project (25,37) to extract variables (Appendix Table 2), e.g., whether a trial had summary results posted at the registry.…”

“…We aimed to systematically evaluate the reporting of results from registered clinical trials at all Nordic medical universities and university hospitals. Our project expands the thorough manual search approach developed and validated in the respective German IntoValue project (15,16,25,26) for ClinicalTrials.gov. We further include the EUCTR, the main mandated registry of Nordic medicinal product trials, and we incorporate methods and insights from the EU Trials Tracker (8) (as further described and expanded upon by DeVito (27)) and the Dissemination of Registered COVID-19 Clinical Trials (DIRECCT) project (28,29).…”