Publication of results from clinical trials (IntoValue)

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. Under the leadership of the Hannover Medical School and in cooperation with the university clinic Freiburg (Cochrane Deutschland), we want to determine the proportion of clinical trials without published results for each of the 36 German medical faculties. For this, we concentrate on all trials completed between 2009 and 2013.

The results of the study are published as a preprint on bioRxiv. Additionally, the accompanying Shiny app allows the interactive visualization of results. A detailed methods protocol and all data and analysis scripts are provided at the Open Science Framework (OSF).
Please find a report from Der Tagesspiegel here (in German).

In the next step, we will contact 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 are also planned.

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

A detailed methods protocol and all data and analysis scripts are provided at the Open Science Framework (OSF). The paper can be found in the Journal of Clinical Epidemiology

Publications

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