In the European Union, clinical trial sponsors- those initiating clinical studies- are required to register their trials in the EUCTR, the European Clinical Trial Register and report results within one year of the completion of their studies. At least that’s the theory because particularly academic trial sponsors are failing their duties: a disappointing analysis of 30 leading European research institutions in 2019 found that only 17% of their study results were reported.
For Sweden, Karolinska Institutet failed to verifiably report the results of 24 clinical trials, with another 83 estimated missing. Despite recent improvements to the submission procedure, the reporting process remains complex. This means universities have to establish structures and procedures to support their academic researchers and it is good to see progress:
‘’Through our commitment to enhance accessibility and transparency of clinical trial data, KI has developed an infrastructure to centralize and manage clinical trial registration and results reporting. KI is working proactively to ensure clinical trial registrations are up-to-date and accurate, and that results are posted for completed trials.”
Professor Anders Gustafsson, KI Vice president
From a cancer patient’s perspective, the European Clinical Trial Register is highly unlikely to be a patient’s first source of information (nor a particularly enjoyable user experience). It is nevertheless a topic close to the heart of our community: Since 2011, the 5-year survival in advanced Melanoma has improved from 5 to over 50%. Every patient diagnosed in the early years who is still alive today has either participated in a clinical trial or in an Early Access Program. Clinical trials remain important treatment options for us and we see the transparent, systematic and standardised reporting of study results as increasing the efficiency in clinical research by enabling accountability and public oversight, access to learnings, quality control and drive further research, including implementation research.
Accountability: Clinical trials are experiments conducted on humans. Learnings should be available to all so that positive findings have a chance to improve care and negative findings are not repeated.
Access: Study results published in diverse scientific journals are only accessible to those who know how to find them and often hidden behind pay-walls. This means that clinical trial participants will be asked to pay to read the results they risked their lives to produce. The EUCTR is open and free to use.
Quality: Standardised reporting in one place means that it becomes easier to compare results with each other, to control for quality and to avoid duplication as it makes it easier for researchers and research funders to verify previous work.
Implementation research: the EUCTR in itself is a resource and can be used to increase transparency by automation like with this Trials tracker or to conduct novel research on e.g. topics like the characteristics of patients included in clinical trials.
We therefore thank TranspariMed for their valuable work- and would like to see Swedish Universities ranking at the top in the next report!
Bettina Ryll and Fredrik Östman