In a significant step toward greater transparency, the World Health Organization and the International Coalition of Medicines Regulatory Authorities are urging drug makers to publish clinical study reports for new medicines and vaccines without redacting any confidential information.
The agencies released a joint statement in which they explained their goal is to ensure research results are publicly accessible so that decision makers — notably, health authorities and physicians — have greater understanding about drugs and vaccines. The agencies also argued releasing trial information that is not redacted would boost public confidence in medical products.
“The priority should be for new innovative medicines and vaccines. This improves transparency and strengthens the validity and value of the scientific evidence base,” the agencies said. They added that not all previous transparency efforts initiated by health officials and regulators have been successful due to a reliance on “goodwill” or a lack of appropriate resources.
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