Registering a trial and posting its results

Registering a trial in a public register and posting its summary results there are duties that attach to the trial itself rather than to a marketing-authorisation application. This branch covers those duties, and its parts divide by the body that sets them: after the registries a sponsor has to satisfy come the journal editors, the World Health Organization, the US statute with the protocol and statistical analysis plan its final rule makes a trial post, the European register under the clinical trials Directive and the national registers of Asia, and then the parts that run across those bodies: the results record a register is owed, registering observational studies and how compliance is tracked. It leaves the senses of disclosure and the milestones by which the requirement grew to what disclosure means and how the requirement grew; the case for disclosure to why clinical trial data is disclosed; what disclosure asks of a writer to preparing documents for public disclosure; the clinical documents published from a marketing-authorisation application to regulators' publication of clinical documents; what the EU Clinical Trials Regulation makes a sponsor register and disclose about one trial to disclosure under the EU Clinical Trials Regulation; what a journal asks to be told about the underlying data to the data sharing statement journals require; participant-level data sets prepared for a secondary user to sharing participant-level trial data; and the plain-language summary of results written for participants to lay summaries of clinical trial results.

• Which registries a sponsor has to satisfy — the US statute and EU regulation the duties rest on, the US and EU registries compared by scope, content and deadline, the national registries, keeping several registries current, and registration and results posting under good clinical practice
• The journal editors' trial registration requirement — registration before enrolment as a condition of publication: how the requirement arose and spread, the registries the committee accepts, which studies count as trials from which date, and how journals check registration dates and treat late registration
• What the World Health Organization asks of sponsors — its statement on disclosing results in registries and journals, publication in a journal within 12 months, making the results of past trials available, and registries joining its Primary Registry Network
• What the US statute requires of a trial's registration and results — which trials the 2007 Act covers and who must post them, its registration and results deadlines and how results may be delayed, the Final Rule and later requirements, the consequences of not posting, the bill that would have extended the Act, and the observational safety data neither addresses
• Posting the protocol and statistical analysis plan on ClinicalTrials.gov — which trials post the two documents under the final rule and why, when they are due, what may be redacted, and the cover page and file format
• Posting summary results to the EU Clinical Trials Register — summary results under the clinical trials Directive and the Paediatric Regulation: when posting to the European database became mandatory, which trials are covered and by when, and what the public sees in the register
• Trial results disclosure in Asia — where a trial is registered and whether its results are posted in China, Japan, South Korea and Taiwan, with China's older registries and drug-evaluation website, Japan's unified registry and its agency's publications, and what the four countries share
• Trial results records for public registries — the structured results record ClinicalTrials.gov and EudraCT each define: its contents, the endpoints the US rule makes it disclose, planning it alongside the study report, who is given access to each database and how the data is entered, a consistent public record, and the US quality control review
• Registering observational studies — why an observational study need not be registered and why registering one is still worthwhile, the registers that accept one, how many are registered, where registration falls in a study, and the questions still open
• How compliance with results posting is tracked — how far results go unreported, the public trackers of the US and European registers, and regulators' reminders to sponsors