New drugs applying for approval in Europe should be tested against
the best available comparable medicine, not against a placebo, as is the
current European Medicines Agency (EMA) requirement, says a new report.
EMA requires only that new drugs be compared to a placebo, except in
cases where it is deemed unethical. According to the report from
researchers at the London School of Economics and the European
Observatory, “This does not allow patients, clinicians, and other
healthcare decision makers to determine whether a new drug is superior,
equivalent, or inferior to its existing alternatives. This can result in
the widespread use of potentially less efficacious and unsafe drugs."
Changing the rule would boost efficiency and result in better, safer
medicines reaching patients faster, researchers argue.
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