The top European regulatory bodies like European Medicines Agency (EMA), European Commission (EC) and Heads of Medicines Agencies (HMA) released a letter to clinical trial sponsors last month. This step was taken to remind them to publish the results of all clinical trials conducted in the EU in EudraCT database.
According to the Clinical Trial Regulation, sponsors of EU-based clinical trials are directed to publish their results within one year of completion and within six months for pediatric trials.
As per EMA, the number of clinical trials registered in EudraCT as of April is 57,687 but only two-thirds (68.2%) of the completed trials have posted results in compliance with the regulation and results of 31.8% of them are still lacking.
77.2% commercial sponsors have posted the results with regulatory compliance whereas the results published by non-commercial sponsors is as mere as 23.6%.
Since September 2018, EMA is also reminding the sponsors of trials with missing results of their reporting obligations.
Clinical Research Newsletter
Mr Vinod Arora, Principal Advisor, IGMPI
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