Regulators and WHO call for public access to clinical trials

The Hague, May 7 (EFE) .- On Friday, the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organiz...

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The Hague, May 7 (EFE) .- On Friday, the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) urged pharmaceutical companies to publish the reports of clinical trials of new drugs so that the results are accessible to all those involved in medical care.

In a joint statement, both organizations emphasized that “systematic transparency” can increase trust in regulatory decision-making, “reassure the public about data integrity,” and “can stimulate research and development”, which could have a “positive” impact on vaccine confidence.

Clinical trials are needed to evaluate treatments

“Clinical trial reports must be published without editing confidential information for reasons of primary concern to public health,” they demand. Emer Cooke, President of ICMRA and Director of the European Medicines Agency (EMA), noted that “the covid-19 pandemic has highlighted the need for greater transparency in medical research” and that requires that reports from clinical trials for new drugs and vaccines are published to ensure that everyone involved in healthcare decisions has access to research.

The EMA itself has committed itself during the pandemic to share on its website detailed reports of its decisions and investigations on vaccines and treatments for covid-19, in search of greater public confidence in its evaluations of authorized drugs in the Union European Union (EU) against the pandemic.

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Drug trials offer transparency

“As our clinical data release policy demonstrates, the EMA has a longstanding commitment to making the data on which our regulatory decisions are based available for public scrutiny,” Cooke stressed. The director of the EMA considered that, if the pharmaceutical companies agree to this request from the ICMRA and the WHO, “it could be the beginning of a new era of much broader access to the data of the results of the trials for the benefit of health public ”, a commitment to“ new ways to improve transparency and data integrity ”.

Another benefit of these measures, the two organizations say, is “the possible verification of the integrity of the data, a scientific necessity and an ethical obligation” because the data “must be robust, comprehensive and verifiable through peer review. The integrity of the data is priceless ”, they warn. EFE

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