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Hayashi’s problem: The use of regulatory information for research synthesis
The latest update to the Cochrane Review ‘Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children’ has recently been published. This updated review is based on full, internal reports of 20 Tamiflu (oseltamivir) and 26 Relenza (zanamivir) trials. These trials involved more than 24,000 people and the findings challenge the historical assumption that neuraminidase inhibitors are effective in combating influenza. This work also challenges the assumption that it is safe to conduct reviews of clinical effectiveness based entirely on published studies.
 Dr Tom Jefferson, Dr Carl Heneghan, Dr Peter Doshi, authors of the review, say that: “Drug approval and use cannot be based on biased or missing information any longer. We risk too much in our population’s health and economy. This updated Cochrane review is the first time a Cochrane systematic review has been based only on clinical study reports and regulatory comment. It is the first example of open science in medicine using full clinical study reports available without conditions. And therefore the conclusions are that much richer. We urge people not to trust in published trials alone or on comment from conflicted health decision makers, but to view the information for themselves.”
Tom Jefferson is the keynote speaker at the InterTASC ISSG workshop. Join us in Exeter on July 9th to hear more. Tom will present and discuss some of these issues on the basis of the oseltamivir (Tamiflu) review, starting with the story of how his team realised their previous Cochrane review on Tamiflu was biased and how they went about addressing this issue.
For further details and to book your place: http://medicine.exeter.ac.uk/pentag/workstreams/informationscience/intertascissgworkshop/