IntoValue

The timely publication of all results from clinical trials is crucial 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 Yet, many study results remain unpublished or are published only with great delay. In the IntoValue project, we aim to determine the proportion of clinical trials without published results as well as time to publication across all German university medical centers.

IntoValue is an ongoing effort, with two completed studies focused on clinical trials completed from 2009 to 2013, and 2014 to 2017, respectively. A third study is ongoing, focused on trials completed in 2018 and a regular follow-up for later years is planned for the future. An interactive visualisation of the results is available as a Shiny app. Detailed protocols on the methodology are available in the Open Science Framework (OSF) for the first and second studies. The combined dataset of results from both studies is freely available on Zenodo. Please see also a report from Der Tagesspiegel.

In a follow-up study, we contacted the principal 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. We also asked researchers general questions on the causes of non-publication or factors promoting (timely) publication of results.

This project takes place in the context of the AllTrials petition in which the BIH participates. This project was initiated in cooperation with the Hannover Medical School and the University Clinic Freiburg (Cochrane Deutschland).