According to the Telegraph newspaper, Public Healt England (PHE), one of the UK's health and social care agencies, has omitted to publish the results of three major clinical trials evaluating pediatric vaccines; neglecting to add test results to the EU Clinical Trial Register (EUCTR), thus preventing the "scientific community from examining the results".
Experts accused the PHE of an "incomprehensible" violation of the trust of parents who gave their consent for their children to take part in the tests. (1)
EUTR was established in 2011 by the European Medicines Agency (EMA) to allow "public access to information on interventional clinical trials for medicines" authorized within the European Union. (2) According to Lise Murphy, an expert member of EMA's scientific committee, EUCTR was launched to increase "transparency of medical research" and "make it much easier for patients to find information on clinical trials taking place in Europe "(3).
The largest of the three vaccine clinical trials, which included 640 children under 16 years of age, was designed to test the safety and efficacy of a new meningococcal and pertussis (pertussis) vaccine. This test was conducted in 2016. EUCTR requires registration of study results within 12 months. (1)
Failure by the PHE to record the results of vaccination tests with EUCTR prevents the public from knowing how children's participation in vaccine studies ended.
However, this neglect is not entirely surprising. According to a recent study published in the BMJ journal, "Compliance with the European Commission requirement for all tests to publish results on the EUCTR within 12 months of completion has been poor, with half of all studies not complying." (4)
The study found that of the 7.247 clinical trials conducted in Europe, only 49,5% of researchers in clinical trials reported the results. (4)
The lead author of the BMJ paper, Ben Goldacre of the University of Oxford, said: "This problem affects the heart of evidence-based medicine. We cannot make informed choices about which treatments work best, as doctors and patients, to unless all results are reported. "
1. Bodkin H. Public Health England withholding vaccines results making it impossible to Establish if drugs could be harmful. The Telegraph Sept. 15, 2018.
2. EU Clinical Trials Register. ClinicalTrialsRegister.eu.
3. Press Release. EU Clinical Trials Register goes live. European Medicines Agency Mar. 22, 2011.
4. Goldacre B, DeVito NJ, Heneghan C, Irving F, Bacon S, Fleminger J, Curtis H. Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource. BMJ 2018; 362: k3218
5. Half of European clinical trials haven't reported results. AllTrials.net Sept. 13, 2018.