WHO, International Regulatory Group Push for Greater Clinical Trial Transparency

The World Health Organization (WHO) and the International Coalition of Medicines Regulatory Authorities (ICMRA) are pushing for drug manufacturers to publish clinical trial reports for new medications and vaccines without redaction of confidential information.

In a joint statement, the agencies argued that making research findings public would “support academics, researchers, and industry in developing vaccines and therapeutics; support regulators and health authorities in their decision-making; support healthcare professionals in their treatment decisions; and support public confidence in the vaccines and therapeutics being deployed.”

The agencies added that manufacturers of innovative medicines and vaccines should be prioritizing open reporting, as it improves “transparency and strengthens the validity and value of the scientific evidence base.”

Whether a product has been approved, authorized for emergency use, or rejected, the agencies say there is no reason to keep the safety and efficacy data supporting those decisions confidential, and that only personal data and individual patient data should be redacted. Pharmaceutical companies have pushed back against this claim, arguing that publishing certain data would compromise patient privacy and hinder competition.

However, the International Federation of Pharmaceutical Manufacturers & Associations trade group issued a statement saying the industry is “fully committed to enhancing public health through responsible sharing” of trial data, as long as it does not compromise patient privacy.

Responding to the WHO and ICMRA statement, a U.S. Food and Drug Administration (FDA) spokesperson told STAT, “The FDA understands the joint statement … to be strategic and aspirational and not a statement of policy. The agency’s actions are governed by U.S. law, driven by our mission to protect the public health, and articulated through agency rulemaking and the issuance of FDA guidance to industry.”

Source: STAT, May 7, 2021.