ICMRA and WHO state clinical trial reports should be published without redaction

The International Coalition of Medicines Regulatory Authorities (ICMRA) and World Health Organization (WHO) is calling on the pharma industry to provide wide access to clinical data for all new medicines and vaccines, whether fully or conditionally approved, under emergency use authorisation or rejected. They stated that clinical trial reports should be published without redaction of confidential information, other than personal or individual patient data, for reasons of overriding public health interest.

In the statement to two organisations said that the COVID-19 pandemic has brought to the fore the need for information and data to support academics, researchers and industry in developing vaccines and therapeutics; regulators and health authorities in their decision-making; healthcare professionals in their treatment decisions; and public confidence in the vaccines and therapeutics being deployed.

According to the agencies, while some such initiatives have met with stakeholder support (eg, WHO International Clinical Trials Registry Platform, US National Institutes of Health (NIH) ClinicalTrials.gov database, Health Canada Clinical Information Portal, European Medicines Agency (EMA) Clinical Trials Register and Japan Registry of Clinical Trials), not all efforts have been successful. Often because they relied on goodwill or lacked appropriate resources. The agencies suggest that to succeed, initiatives need multi-stakeholder engagement.

The organisations suggest the benefits of transparent data sharing include public trust; checking data integrity; removing a source of bias, lack of public access to negative trials has been identified as a source of bias, weakening conclusions of systematic reviews and providing a false sense of reassurance on the safety or efficacy of medicines; allowing science to advance faster, by avoiding repetition of unnecessary trials and wasting resources; and improving overall data quality and standardisation with public scrutiny.

They acknowledged that while there may be a small risk of misuse of data (piracy or data mining for unfair commercial purpose) and misinterpretation, trial data could be put in context when published with a regulatory review.

They argue that it cannot be justified to keep efficacy and safety data of a medicine available on the market, or which has been refused access to the market, confidential. As such data must be published at the time of finalisation of the regulatory review. They acknowledge that some regulators regularly publish the data that support positive approvals, but fewer do this for rejections, and that many completed trials on publication platforms only disclose protocols while results remain partial, outdated or unpublished.

ICMRA and WHO stated that while they are conscious of concerns that some stakeholders may have as regulators move to greater levels of transparency, they remain confident of the overwhelming positive public health benefits of doing so.

They concluded their statement: “Providing systematic public access to data supporting approvals and rejections of medicines reviewed by regulators, is long overdue despite existing initiatives, such as those from the European Medicines Agency and Health Canada. The COVID-19 pandemic has revealed how essential to public trust access to data is. ICMRA and WHO call on the pharmaceutical industry to commit, within short timelines, and without waiting for legal changes, to provide voluntary unrestricted access to trial results data for the benefit of public health.”