Comparing regulatory transparency in Europe, the United States and Canada

Three major medicines regulators are providing more access to key data than ever before, a new study comparing the transparency policies and practices of the European Medicines Agency, the US Food and Drug Administration, and Health Canada has found.


The study focuses on Clinical Study Reports, highly detailed documents that contain important information on the conduct and outcomes of clinical trials that cannot be found elsewhere, but also covers Individual Patient Data plus other types of data and documentation.


(For those not familiar with Clinical Study Reports and Individual Patient Data, this report by Transparency International and Cochrane provides a quick overview of what they are and why they matter to patients.)


Key findings:


CLINICAL STUDY REPORTS


Redactions. The three regulators make only “minimal” redactions to Clinical Study Reports (CSRs) to remove commercially confidential information and data that may endanger patients’ anonymity. Those redactions “generally did not impede interpretation of the evidence,” which is good news for patients.

Proactive disclosure. Only Health Canada and the European Medicines Agency proactively disclose new CSRs. While the Canadian regulator makes CSRs fully public, the European regulator places restrictions on who can access them, and how. The US Food and Drug Administration has yet to start proactively disclosing CSRs.


Reactive disclosure. All three agencies have mechanisms that allow researchers to gain access to older CSRs and other regulatory data upon request. Health Canada provides CSRs far faster and in a more accessible format than the other two regulators do.


INDIVIDUAL PATIENT DATA


Access to Individual Patient Data. Access to IPD via regulators is still impossible in practice. Only the US Food and Drug Administration releases IPD on request, but it when does so, it redacts the data so heavily that they are useless. The European Medicines Agency has formally committed to making IPD accessible in future, but this is not likely to happen any time soon. Health Canada does not have an IPD sharing policy.


ACCESS TO OTHER TYPES OF DATA


The three regulators differ widely in which other types of data they will release:


“In response to our parallel requests for information supporting approval of Sovaldi and Harvoni, FDA and HC released substantially more regulatory data than EMA, including clinical overviews, summaries and integrated summaries of safety and efficacy, clinical study protocols and amendments, and narratives of deaths and serious adverse events. Information only made available by FDA include individual safety case reports; records and correspondence related to product labeling, safety concerns, pediatric studies, expedited approval pathway designations, and postmarket s


tudy requirements and commitments; safety update reports; site initiation visit reports; and IPD, albeit heavily redacted. Information only produced by HC include sample case report forms and statistical analysis plans. Information only made available by EMA include periodic safety update reports and pharmacovigilance risk assessment committee reports.”


For more details, please read the original study.



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