Friday, May 7, 2021

WHO, Medicines Regulators Call On Drug Manufacturers To Open Access To Clinical Data - UrduPoint

The WHO and the International Coalition of Medicines Regulatory Authorities (ICMRA) urged the pharmaceutical industry to open access to clinical data for all new medicines and vaccines for reasons of "overriding public health interest."



Making relevant data on innovative vaccines and medicines readily available will increase public trust in the treatment options, streamline global research efforts, increase data quality and help with healthcare policy making, the document stated.

"Publication of data allows science to advance faster, by avoiding repetition of unnecessary trials and waste of resources (human and financial). This also brings benefits by improving the efficiency of development programmes and reducing both development costs and time," the official statement said.

According to the press release, drug manufacturers should share all relevant data, including negative results, and redact only personal data of individual patients.

Such research-sharing mechanisms will ensure transparency and strengthen "the validity and value of the scientific evidence base," the statement said.

Currently, only few of such data-pooling initiatives have succeeded, such as the WHO International Clinical Trials Registry Platform or the US NIH ClinicalTrials.gov database, among others. However, the statement stressed, that majority of these efforts fail due to reliance on the goodwill of private companies and lack of funding.

ICMRA and WHO said they were aware of concerns raised by manufacturers concerning greater levels of transparency, but "remain confident of the overwhelming positive public health benefits of doing so."    SPUTNIK

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