Up to 1/5 of Clinical Trials on Humans Never Published, Finds Shocking New Report
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The results of around one-fifth of clinical trials carried out by medical centres are never published, despite WHO guidelines saying they should be to benefit future research and patients.
A new study by the Faculty of Health Sciences of the Jagiellonian University in cooperation with scientists from the QUEST Center of the Charité Universitätsmedizin in Berlin fond that many institutions failed to publish the results of their research if it didn’t match the results they were hoping for.
To approve marketing of a new type of therapy, e.g. a drug, it must first undergo many phases of research that confirm its safety and effectiveness.
After being tested on animals, it is then tested on humans in clinical trials. Subsequent phases of the research allow scientists to determine how a given agent affects people.
According to the 2015 guidelines of the World Health Organization (WHO), within 12 months of the end of a clinical trial, results should be published in an online database where the study is registered (and each trial must always be registered in one of the databases). A scientific publication on the subject should appear within a maximum of the next 12 months.
To find out how often institutions comply with the WHO guidelines, the researchers analysed 305 clinical intervention studies completed between 2009 and 2013. These were studies in which at least one Polish academic medical centre participated, registered in one of the most popular clinical research databases, ClinicalTrials.gov.
They found that although 79 percent results of clinical trials were published (as a scientific article or as information in the ClinicalTrials.gov database), every fifth clinical trial was missing.
Writing in BMJ Open (doi.org/10.1136/bmjopen-2019-034666) the report authors said: “The good news is that Polish centres disseminate research results slightly more effectively than medical centres in the US or Germany. Still, we still have a lot to do in this area.”
According to co-author, Dr. Marcin Waligóra, scientists particularly fail to publish the results of those studies that have not brought the expected results. In this situation, the authors lack motivation to publish the results of their work. The system doesn't reward them for that, and publishing studies that didn't work out takes time.
But, the authors warned: “If we do not publish all the research results, we will repeat the same mistakes.”
In example, Waligóra said that in 2006, the early phase of clinical trials with Theralizumab in the United Kingdom led to serious side effects (volunteers who tested the drug ended up in the intensive care unit). This, he said, “could probably have been avoided because, 10 years earlier, studies on the Theralizumab-like substance that showed very similar side effects were suspended. Unfortunately, the results of that previous study have never been published.”
Lead author Karolina Strzebońska added: 'Most of the clinical trials included in our analysis were so-called multi-centre studies, conducted simultaneously in over 100 centres around the world, where Polish institutions were one of the partners. Over 70% of these studies were financed from non-public funds, for example by the pharmaceutical industry. Polish centres have not always been the leaders of this research but both Polish researchers and the authorities of Polish medical centres can do a lot to finally bring the results to light.”
The study was financed by the National Science Centre.
PAP - Science in Poland
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