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One of our first projects, the IntoValue project, is concerned with the publication of clinical trials. The publication of all results from clinical trials is an important component for improving biomedical research and reducing the amount of unused research results. This is also an obligation towards the participants of clinical trials and their contribution to research.

Yet, many study results are not being published at all or only with great delay. In cooperation with the Hannover Medical School and the university clinic Freiburg (Cochrane Deutschland), we want to determine the proportion of clinical trials without published results for the 35 German medical faculties.

Two studies have already been conducted in this regard: The first study focused on clinical trials completed in the years 2009 - 2013, while the second follow-up study looked at the years 2014 - 2017. The results of the first study are available as a preprint on bioRxiv and as a publication in the Journal of Clinical Epidemiology, while the results of the second study are currently only available as a preprint on medRxiv. In addition, the associated Shiny app allows interactive visualization of the results. A detailed protocol on the methodology have been made available in the Open Science Framework (OSF) for the first and second studies. The combined dataset of results from both studies has been made freely available on Zenodo. Please find a report from Der Tagesspiegel here (in German).

In the next step, we contacted the principle investigators, sponsors and (in the case of studies with results publications identified by us) corresponding authors to validate the results of study in an online survey. In addition to this validation, general questions on the causes of non-publication or factors promoting (timely) publication of results were also planned.

This project takes place in the context of the AllTrials petition in which the BIH participates.

Publications

Nico Riedel, Susanne Wieschowski, Till Bruckner, Martin R. Holst, Hannes Kahrass, Edris Nury, Joerg J. Meerpohl, Maia Salholz-Hillel, Daniel Strech. Results dissemination from completed clinical trials conducted at German university medical centers remains delayed and incomplete. The 2014-2017 cohort. medRxiv 2021, preprint, doi.org/10.1101/2021.08.05.21261624

Wieschowski S, Riedel N, Wollmann K, Kahrass H, Müller-Ohlraun S, Schürmann S, Kelley S, Kszuk U, Siegerink B, Dirnagl U, Meerpohl J, Strech D (2019). Result dissemination from clinical trials conducted at German university medical centers was delayed and incomplete. J Clin Epidemiol. 2019 Nov;115:37-45

Strech D, Sievers S, Märschenz S, Riedel N, Wieschowski S, Meerpohl J, Langhof H, Müller-Ohlraun S, Dirnagl U (2018). Tracking the timely dissemination of clinical studies. Characteristics and impact of 10 tracking variables. F1000 Research; 2018 Nov 29;7:1863

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