A new data analysis estimates that data "disappears" when the results of about half of the clinical trials are published
According to New data analysis published In the online journal PLOS Medicine, in about half of the studies published about new medical treatments, the researchers omit the negative effects they discovered. A team of British researchers conducted the survey after encountering certain cases of omission of side effects in the medical literature, including studies by pharmaceutical companies, hospitals and academic institutions. To determine the extent of the problem, they analyzed 28 articles from the scientific press that cross-referenced data from more than 500 published clinical trials with their original data. The results of the review quantitatively confirmed that some drugs can cause side effects that even doctors do not know about. This means that the treatments are not as safe as they are presented, says Yun Lok, a doctor and lecturer at the University of East Anglia in Norwich, UK. Scientific American spoke with Luke about the importance of transparency in medical data. Here are the highlights of the conversation.
Scientific American: Why are these results worrying?
Yun Lock: What we found confirms our suspicions: data omission is very common. The articles published in the scientific press often report a lower rate of adverse events than those observed in the clinical trial. We see this phenomenon as very worrying. We want the best for the patient, but if we only have access to half of the information, the decision or choice of a certain drug or device may be much less reliable than we would like.
Why are problematic events not reported?
I think one problem is that journals are limited in the place and scope they can publish. I myself was an editor of a scientific newspaper and often you want to publish positive and interesting things that people want to read. This is the optimism bias. There are many other issues that the survey alludes to. For example, when a company wants to market a product, it is much more profitable for it to publish promising data and ignore negative events.
What can the patient do?
If you are a patient participating in a clinical trial, you can make signing the consent form conditional on your wish for the results of the study to be made available to the public. on the website Alltrial.net, there is a large group of people running a campaign of persuasion to promote the registration of all experiments and the publication of all results so that so many results are not hidden. I hope that with the help of the public's voice, and the US Food and Drug Administration's recent tightening of regulatory requirements, data on adverse events will be available to a much larger audience.
good to know
Data must not disappear
As of January 2017, all American researchers who conduct clinical trials must publicly publish all their findings, regardless of the results of the study. This is determined by a new guideline from the US Department of Health and the US Institutes of Health (NIH). Meanwhile, the Evidence-Based Medical Data Lab at the University of Oxford has put a new tool online, Trials Tracker, that finds out exactly who is hiding data.
Sil Lane's lecture: the dark side of clinical trials
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