IntoValue - Institutions’ contribution to increasing value and reducing waste

Clinical trial dissemination rates of all German university medical centers

The following Shiny app accompanies the two publications on the clinical trial dissemination rates of all German university medical centers and allows to further explore the results. The publications are 'Result dissemination from clinical trials conducted at German university medical centers was delayed and incomplete' and 'Results dissemination from completed clinical trials conducted at German university medical centers remains delayed and incomplete. The 2014-2017 cohort'. You can interactively choose different subsets of the data and different ways of defining timely publication. The results can be displayed both as diagram or in a table (see navigation bar at the top). Additionally, a Kaplan-Meier curve for the percentage of unpublished studies over time can be displayed for different subgroups of the data as well as different stratifying variables. The dataset, analysis code, as well as detailed methods can be found on the OSF project pages for the first and the second study and this Github repository. The combined dataset for both studies can be found here.

What counts as timely publication?

Count summary results

Publications and Summary results Publications Summary results (CT.gov only)

Count from which completion date

Completion date Primary completion date (CT.gov only)

Published within how many month

12 24 30 36 48 60 Any duration (trials with >6 years follow-up period) Any duration (any follow-up period)

Publication identified in which stage

Registry only Full search (incl. Google Scholar)

There are different ways to define what a timely publication is. First, study results can either be posted as summary results on the registry or published in a peer-reviewed journal. Second, there are different dates on which a study could be considered completed: either the primary completion date (when all data for the primary endpoints were collected) or the completion date (last patient last visit). Third, there are different recommendations on how long it should take to make study results available. Note: when different periods are choosen in the "Published within how many month"-box, only those trials are considered that we were able to track for this period (e.g. 60 month since the completion date). Only exception is the category "Any duration (any follow-up period)", where all trials are considered.

Different subgroups

Study version*

Any IntoValue1 IntoValue2

Registry

CT.gov + DRKS CT.gov DRKS

Completion status

Any status Completed Terminated Unknown status Suspended

Responsibility level

Lead or Facility Lead trials only Facility trials only

Registration at which timepoint

Any In the month of the trial start or earlier After the month of the trial start After trial completion (CD) After trial completion (PCD) After publication

Number of centers

Mono- or Multicentric Multicentric Monocentric

Sponsor from industry or not

Any Industry Academic

Trial phase

Any I I-II II II-III III IV Not given

Type of intervention

Any Drug Device Other

Number of participants

Any <100 100-500 >500 Not given

Completion year

Any 2009 2010 2011 2012 2013 2014 2015 2016 2017

There are many choices on which group of clinical trials to consider. All of these choices alter the results for the final publication rates. Only the trials in our dataset that match the set filter criteria are considered for the calculation of the timely reporting percentage. *There are 128 trials that are part of the samples used for both studies. The reason for this is either a change in the completion date in the registry after the end of the IntoValue1 study or the change in the search criteria from primary completion date (IntoValue1) to completion date (IntoValue2). In those cases the results from the second study are shown when "Any" or "IntoValue2" is chosen. When "IntoValue1" is chosen, the results from the first study are shown.

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