Global regulators issue call for clinical trial data transparency

Regulatory NewsRegulatory News | 07 May 2021 |  By 

World regulatory authorities are calling for increased transparency from the pharmaceutical industry in how they report and give access to clinical trial data. In a joint statement, the World Health Organization (WHO) and the International Coalition of Medicines Regulatory Authorities (ICMRA) cited need for “wide access to clinical data for all new medicines and vaccines.”
Data related to a therapy or vaccine “must be published at the time of finalization of the regulatory review,” they said, regardless of whether the decision is positive or negative. “It cannot be justified to keep confidential efficacy and safety data of a medicine available on the market, or which has been refused access to the market.”
The two bodies cited “overriding public health interest” in their statement, which called for pharmaceutical companies to report clinical trial results without redacting information that would otherwise be confidential because of commercial reasons. Only personally identifying information and individual patient data should be redacted from publicly available clinical trial data, wrote WHO and ICMRA.
“In any case, aggregated data are unlikely to lead to re-identification of personal data and techniques of anonymization can be used,” wrote WHO and ICMRA. Ensuring data integrity is “a scientific necessity and an ethical must,” and when data are incorrect or incomplete, public harm can result if regulators make decisions based on the faulty foundation of these flawed data.
Additionally, when negative trials are not published, the scientific literature is incomplete. This can lead to further downstream problems when researchers and policy analysts conduct systematic reviews of available evidence to weigh benefit and risk for therapies; if negative data are not found in the literature, the review may result in an erroneously positive assessment of the benefit-risk equation.
Further, publication of negative trials can streamline the development process by avoiding unnecessary replication of failed strategies, pointed out the bodies.
The statement points to the need for global cooperation and information-sharing that arose during the public health emergency of the COVID-19 pandemic. Clinical trial registries in the US, Canada, the EU and Japan, as well as WHO’s international trial registry platform, all have received support from multiple stakeholders, note the bodies.
The WHO-ICMRA statement comes the same week the Biden administration called for waiver of intellectual property (IP) protection for COVID-19 vaccines, to the delight of consumer protection and public health advocacy groups; the proposal was swiftly and roundly condemned by many pharmaceutical industry groups. (RELATED: Pharma groups slam US decision to support COVID-19 vaccine patent waivers, Regulatory Focus 06 May 2021)
ICMRA’s membership includes the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the UK’s Medicines & Healthcare products Regulatory Agency (MHRA), among other global regulators.
Despite multilateral efforts, “not all past efforts have been successful,” with failure arising from reliance on mere goodwill, or because of inadequate resources, according to the statement, which cited the example of Roche’s failure to follow through on earlier pledges for increased access to clinical trial data. Ongoing negotiations over increased transparency have drawn valuable resources from regulators, who struggle to ensure that pharmaceutical companies publicly share both positive and negative clinical trial data.
In the US, most results of clinical trials registered at are not posted there within a year of trial completion, despite requirements set forth in Section 801 of the 2007 FDA Amendments Act (FDAAA) and formalized in a final rule in 2016. More than a third of clinical trial results never make it to the website, according to a 2020 study published in The Lancet.
Though FDAAA provides for civil monetary penalties for failure to report clinical trial results, FDA had long stayed its hand. Just last month, however, the agency sent a notice of noncompliance to Massachusetts-based Acceleron for failing to report results of its clinical trials. According to the notice, the firm has 30 days from the issuance of the notice to correct the defect or face a civil penalty of up to $10,000 per day of continued non-compliance. (RELATED: FDA threatens drugmaker with fines for failing to report trial results, Regulatory Focus 28 April 2021)
FDA’s actions against Acceleron came after finalization of a guidance that details how and when the agency would penalize firms that failed to register or report results from clinical trials or submit required certifications. (RELATED: Penalty policy for trial reporting violations finalized, Regulatory Focus 14 August 2020)
The bodies also noted that increased public trust in needed therapies and vaccines is likely to be an additional benefit of more transparent handling of clinical data. The statement seeks to reassure “some stakeholders” who have concerns about fully unveiling clinical trial data, citing the great public health benefits that could be reaped from a more open process.
“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,” wrote the two bodies.
Joint ICMRA-WHO statement


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