Tips and tricks for improving clinical trial reporting from Karolinska university
Sweden’s Karolinska university has successfully improved the registration and results reporting of clinical trials though a centralised approach.
Karolinska research support staff have now published a paper explaining how they managed the process and providing tips and tricks for other institutions.
Below key verbatim passages from the paper, which can be accessed for free online.
How did they do it?
Senior management decided to fix the problem, and gave a research support office responsibility - and additional resources - for getting clinical trial results fully reported.
Staff then started uploading the summary results of all completed drug trials (CTIMPs) onto the European trial registry EudraCT:
Via the EU Clinical Trials Register database, all of KI's clinical trials that were registered in EudraCT were located and then entered into an internal document. Trials that had incorrectly indicated KI as principal were purged.
As many trials lacked a registered responsible researcher, manual searches were made in Pubmed/Google for published articles in the hope of finding a responsible researcher among the manuscript authors.
An administrator account was created in the EudraCT portal to be able to upload results to all KI trials.
To facilitate reporting, a results template was prepared in September 2022 that contained the mandatory fields in the EudraCT portal. The template is now sent out to researchers who fill in the results, without having to get an account and learn how to navigate the portal. Based on the template, the [research support office]… can easily and time-efficiently upload the results.
[The research support office] offers individual research support primarily via email, but also offers lectures and workshops for research groups and doctoral schools at KI. In the spring of 2021, instructions were drawn up and a comprehensive web page was launched on KI's internal web with, among other things, step-by-step guidance for various study registers and frequently asked questions.
Tips and tricks
The paper offers the following advice based on Karolinska university’s experiences:
It is of great importance to have support from the management, who need to ensure that resources can be set aside for long-term research support.
Start with the "simple" trials.
Make it easy for the researchers! Give clear and detailed step-by-step instructions when contacting by email.
Provide important and detailed information on an internal website so that researchers can easily find what needs to be done and how, as well as contact persons.
Develop a results template for EudraCT that the researchers can fill in: this greatly facilitates reporting for the staff.
Join networks of research administrators working on registration and results reporting for tips and advice.
Note: TranspariMED has separately compiled a collection of transparency tools, including the QUEST manual on trial reporting.
Reporting results for all trials
In Sweden and other major European countries, it is still completely legal to run a non-drug trial and never publish its results. By law, only drug trials must publish results.
Nonetheless, Karolinska university has voluntarily begun also actively managing its records on the ClinicalTrials.gov registry, the paper notes. For ongoing trials, research support staff remind researchers to keep their records updated, and ask them to upload results once they complete a study.
Studies show that many universities in the UK and in Germany have so far only improved their reporting of drug trials results, but not for non-drug trials. However, some of these universities now appear to be broadening their approach to cover all clinical trials.
Till Bruckner, founder of TranspariMED, said:
“It is wonderful to see that Karolinska university had invested considerable time and resources into uploading trial results onto the European registry. Research shows that results posted on registries contain more and better data on trial outcomes than journal publications do, so this benefits both patients and science."
Karolinska research support staff note in the article that campaigning by TranspariMED played a role in convincing university management to address the problem.
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Note: Extracts from the article cited above were translated with Google translate. Oxford university’s EU Trials Tracker distinguishes between Karolinska Institutet and Karolinska University Hospital. Both entities have significantly improved their reporting of drug trial results in recent years.