Abstract
ObjectiveTimely publication of clinical trial results is central for evidence-based medicine. In this follow-up study we benchmark the performance of German university medical centers (UMCs) regarding timely dissemination of clinical trial results in recent years. MethodsFollowing the same search and tracking methods used in our previous study for the years 2009 – 2013, we identified trials led by German UMCs completed between 2014 and 2017 and tracked results dissemination for the identified trials. ResultsWe identified 1,658 trials in the 2014 –2017 cohort. Of these trials, 43% published results as either journal publication or summary results within 24 months after completion date, which is an improvement of 3.8% percentage points compared to the previous study. At the UMC level, the proportion published after 24 months ranged from 14% to 71%. Five years after completion, 30% of the trials still remained unpublished. ConclusionDespite minor improvements compared to the previously investigated cohort, the proportion of timely reported trials led by German UMCs remains low. German UMCs should take further steps to improve the proportion of timely reported trials.
Highlights
And comprehensive reporting of clinical trial results is a crucial aspect of evidence-based health care and responsible research
For clinical trials led by German university medical centers (UMCs) that were completed in recent years (2014 –2017), 43% published their results within 24 months after completion date
35 German UMCs via their name in different spelling variants (ClinicalTrials.gov: UMC listed as responsible party, lead sponsor or with a principal investigator (PI) from UMC; DRKS: UMC listed as primary sponsor; Kiel and Lübeck share a single UMC since 2003; our current dataset represents this as a single UMC, whereas the former study included them as separate UMCs)
Summary
We identified 1,658 clinical trials via ClinicalTrials.gov (n = 1,227) and DRKS (n = 431) that i) were counted as lead trial for at least one German UMC and ii) had their completion date between 2014 and 2017. Of these trials, 402 (24%) investigated drugs while 276 (17%) investigated devices; the remaining trials were assigned to other intervention types (549 trials, 33%) or mentioned no intervention type (431 trials, 26%). 402 (24%) investigated drugs while 276 (17%) investigated devices; the remaining trials were assigned to other intervention types (549 trials, 33%) or mentioned no intervention type (431 trials, 26%) A total of 1,285 trials (78%) were completed and 148 (9%) were either terminated early or suspended; for 225 trials (14%), the status was unknown
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