New drugs need to be tested longer and by more people: study
New medicines for people with a chronic condition need to be better researched for efficacy and side effects, according to a Dutch-led study published in an academic journal on Wednesday.
Researchers from Utrecht University together with the Dutch and British drugs regulators found studied drugs brought on the market between 2000 and 2010 and found many did not meet guidelines for medicine testing.
For treating chronic conditions, the guidelines say that 1,000–1,500 patients should be exposed to the new drug and that 300 and 100 patients use the drug for six and 12 months, respectively, before it is approved for use.
But in up to 15% of cases this does not happen, news agency ANP reported.
The study looked at 200 new medicines approved for use by the EU and concluded that the study size and long-term data requirements should be improved, particularly for drugs designed for long-term use.
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