Regulators' publication of clinical documents

Regulators publish clinical documents from a marketing-authorisation application: the European Medicines Agency publishes selected documents under its Policy 0070, and Health Canada and the US Food and Drug Administration release clinical information in programmes of their own. This branch covers that publication, and its parts divide by what a question about it concerns: the European policy's rules and how they stand beside release on request, the portal its documents appear in, how it was drafted and adopted, its course from its first year of publication through its suspension to its relaunch, and the Canadian and US programmes set against it. It leaves the place of Policy 0070 among the milestones of disclosure to what disclosure means and how the requirement grew; the case for disclosure to why clinical trial data is disclosed; the writer's work on a package, its anonymisation, the content of the anonymisation report and what is commercially confidential to preparing documents for public disclosure; what the EU Clinical Trials Regulation makes a sponsor disclose about one trial to disclosure under the EU Clinical Trials Regulation; the duties to register a trial and post its results to registering a trial and posting its results; and participant-level data sets prepared for a secondary user to sharing participant-level trial data.

• What EMA Policy 0070 requires and which documents it publishes — the obligation it adds to a marketing-authorisation application and its deadline, the applications and guidance version in scope, the clinical reports, summaries and overview it publishes, the disputed laboratory tables, the anonymisation report it requires, and the trial-level documents it affects without publishing
• How Policy 0070 differs from the access-to-documents policy — proactive publication against release on request under Policy 0043, their legal basis and scope, the personal data and confidential information both protect, when documents become available and the holder's work starts, who anonymises and how redactions are marked, and a document caught by both
• Using the EMA clinical data portal — the two access tiers, research access from outside the EU, the home page's tabs, searching and exporting results, downloading a procedure's documents, and the summary data the portal holds rather than individual patient data
• How Policy 0070 was drafted, contested and adopted — the dispute over access and the stakeholder workshop of November 2012, the draft and the objections it drew, the public consultation and the principles agreed before adoption, the targeted consultation and the board's agreement, the postponed adoption, entry into force and the implementation guidance
• How publication under Policy 0070 ran, stopped and restarted — the policy's course from launch to relaunch, the open access given in October 2016 and the first implementation report, who used the published data and what the agency claimed for the policy, why publication stopped in 2018, the guidance set for its resumption, the hold through 2019 and 2020, the exception for COVID-19 medicines, what the 2023 relaunch covered and asked of sponsors, when it took effect, and step two and the legacy documents
• How Health Canada and the FDA release clinical information — Health Canada's Public Release of Clinical Information, what it releases, its process and timelines, where it departs from Policy 0070, its anonymisation and redaction, reuse of packages approved under Policy 0070 and its portal, the FDA's clinical data summary pilot, and where the three regulators stood