gms | German Medical Science

Background/research question: Prospective registration of trials is considered a scientific, ethical and moral responsibility by the WHO. Since 2014, registering clinical trials in a primary registry endorsed by the WHO or in Clinicaltrials.gov is a legal requirement in Switzerland. To increase registration rates of interventional and particularly observational studies at the Universitätsspital Basel (USB) the Department of Clinical Research developed a systematic concept. Since 2018 we offer Clinicaltrials.gov registration as service for every researcher at the USB. Here we compare the registration rates across Swiss University Hospitals, describe automated results reporting and investigate the effect of the new registration policy of the USB.

Methods: We export data of all clinical studies with a Swiss University Hospital as sponsor from Clinicaltrials.gov., extract study information and metadata and examine registration patterns stratified by study characteristics. We automatically search publications using the Clinicaltrials.gov NCT-ID for studies completed before 2018 (Powell-Smith and Goldacre 2016).

Results: As of September 2019, the 5 Swiss University Hospitals registered 1272 interventional and 770 observational studies. Inselspital Bern, USB and Universitätsspital Zürich registered 413, 540 and 751 studies, of which 47% , 34% and 37% were timely registered. The Centre hospitalier universitaire vauDOIs (CHUV) Lausanne and the Hôpitaux universitaires de Genève (HUG) registered studies less frequently and less timely. Overall, interventional studies are registered timelier than observational (42% vs 26%). In 2018, 79 studies were registered at the USB, 97% more than the annual average of the previous five years. Much of this increase is due to observational studies (plus 221%).

For 42% of interventional trials completed at least 2 years ago we found a publication automatically.

Conclusion: There are substantial differences of clinical study registration across Swiss University Hospitals, with lowest rates in the largest hospitals. The new registration policy of the USB leads to a duplication of the annually registered clinical studies.