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Clinical trial reports are missing – dan sfera – Medium

Result Reporting?

Knowing that a good deal of clinical trial data goes unreported, the U.S. Congress passed a law in 2007 that required clinical trial sponsors to post the results of specified clinical trials on clinicaltrials.gov within a year of trial completion. In January 2017 the rule was finalized.

Since that time, 40 top US universities should have been posting the results of 450 clinical trials. It seems that more than one third (31 percent) of those results are missing, according to an analysis by Universities Allied for Essential Medicines (UAEM) in partnership with non-profit research advocacy group TranspariMED, reported Natalie Grover in Endpoints.

Guilty parties include numerous active trial sponsors. They are the MD Anderson Cancer Center, which has only reported 77 percent of clinical trial results that were due, Mayo Clinic (42 percent), UC San Francisco (37 percent), New York University (21 percent) and Columbia University (17 percent). This is symptomatic of a trend in which educational institutions in the United States and the United Kingdom — undoubtedly the two biggest regions of the world that have a large share of medical innovation — are some of the biggest violators in non-reporting of clinical trial results.

People are concerned about these transparency violations, because at least half of the valuable medicines that exist today were originally developed in university labs with taxpayer funding, the analysis noted. Those medicines include nearly all vaccines, many HIV and tuberculosis drugs, and even insulin. According to a study that was published in the official journal of the National Academy of Sciences, between 2010 and 2016, every one of the 210 FDA-approved medicines can be traced back to funding from the NIH. Where are taxpayer dollars going, and why are we not getting results.

At the same time, there is a lack of transparency among academicians in the UK, where regulations are similar to those in the US. It is a requirement that any clinical trial of any medicinal product conducted since 2004 in an EU country has to register on the European Union Clinical Trials Register (EUCTR). Furthermore, since 2012, sponsors need to ensure that all registered trials since 2004 divulge their results to the EMA within 12 months of trial completion. Because of delays to the EMA’s software platform, the final date for results posting by sponsors was pushed to late December 2016.

Ben Goldacre, a best-selling author, medical doctor and researcher who focuses on unpacking the misuse of science and statistics in his books led a BMJ study published in 2018. It determined that in Europe, of the 7274 trials in which results were due, 49.5 percent reported results. Clinical trials with a commercial sponsor were much more likely to post results than those with a non-commercial sponsor.

From his labs at the University of Oxford, Goldacre established an EU TrialsTracker to continuously monitor the reporting of clinical trials. By January 10, Goldacre’s team identified 8,062 registered trials that are “unambiguously” due to report results> Only about half (53.6 percent) have been posted to the registry. Because the data suggested that UK universities were less likely than drug developers to report results, the House of Commons Science and Technology Committee got involved. If UK universities fail to improve their track record, they might be brought in front of the committee and required to explain why not.


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