2023/12 - Latest news from KCE Trials

New: KCE Trials Clinical Research Transparency Policy and first monitoring report on transparency practices for KCE Trials funded studies

Transparency of clinical trials plays a critical role in advancing scientific knowledge, improving patient care, and facilitating evidence-based decision making. KCE Trials has recently adopted the WHO's best practice for funders in a new Clinical Research Transparency Policy. We have adapted our funding contracts and internal procedures to better implement this international best practice. In parallel with the development of this policy, we conducted an internal monitoring exercise, assessing the WHO best practice guideline, point by point for all trials funded by KCE Trials from 2016 to today.

The KCE Trials Policy on Transparency in Clinical Research aims to ensure that:

All trials are prospectively registered (before the first participant is recruited) in a publicly available database (preferably clinicaltrials.gov), and these records are kept up to date.
A summary of the trial results is available within 12 months of the end of the trial (defined as the last participant visit for the primary outcome).
A peer-reviewed scientific publication reporting the main results of the trial is available within a maximum of 24 months after the end of the trial.
The main publication of the trial results is open access, and that all publications include the trial registry ID.
The trial results are published in the appropriate section of the registry (not just as a link to the publication).
A clinical study report containing the results of all planned analyses for all endpoints listed in the protocol (including exploratory analyses), is available within a maximum of 24 months after the end of the trial, on our website.
A layman’s summary of the results is published on the KCE website in three languages (English, Dutch, French).
The initial version of the protocol is publicly available before FPI. The last (amended) version of the protocol is publicly available when results are disclosed.

Main results of monitoring report are:

83% (29/35) of trials were registered prospectively (before recruitment started) in a publicly available registry.
41% (7/17) of completed trials published their results within 12 months of the end of the trial.
0% (0/17) of completed trials reported a summary of results directly in the trial registry within 12 months of the end of the trial.
88% (15/17) of completed trials had their protocol publicly available.
100% (50/50) of the publications (results or protocols) were open access.
94% (47/50) of the publications mentioned the trial registry ID