临床试验透明度现状：2025年的发展和2026年的预测

The S tate of Clinical Trial Transparency:2025 Developments and 2026 P redictions Contents 2025 Global Disclosure Updates32026 Clinical Trial Disclosure and Transparency Predictions5The Shift from Compliance to Core Principle5The Game Changer: ICH E6(R3) Elevates Transparency6The Maturation: Europe Builds Its Transparency Infrastructure7The Uncertainty: US Transparency at a Crossroads9The Enabler: AI Moves from Hype to Help10The Divergence: Fragmentation Despite Harmonization12Enforcement for Noncompliance: Who Blinks First?13What This Means for Disclosure Professionals13Conclusion: From Compliance to Culture14Citeline Disclosure Resources14 The S tate of Clinical Trial Transparency:2025 Developments and 2026 P redictions 2025Global Disclosure Updates Europe Switzerlandrevised trial disclosure requirements under theClinical Trials Ordinance (ClinO),effective March 2025, mandating lay-friendly summary results within one year for newly completedstudies. The requirement applies only to trials completed after the effective date. To implementthese changes, the Federal Office of Public Health launched HumRes on March 1, 2025, replacingthe Swiss National Clinical Trials Portal (SNCTP). Trial submissions continue through the BusinessAdministration System for Ethics Committees (BASEC). TheEuropean Union’sClinical Trials Information System (CTIS) obtained WHO primary registrystatus within theInternational Clinical Trials Registry Platform (ICTRP)in April 2025, meetingInternational Committee of Medical Journal Editors (ICMJE) standards and clarifying its role in theglobal registry ecosystem. TheUnited Kingdomenacted theMedicines for Human Use (Clinical Trials) (Amendment)Regulations 2025in June, effective April 28, 2026. The Health Research Authority publishedfinal guidance in October clarifying that trials must be registered on WHO-recognized registriesbefore first participant recruitment or within 90 days of approval (whichever is sooner). Resultspublication is required within 12 months, and plain language results summaries must be offered toall participants and published on the public registry within the same timeframe. The Netherlandspermanently discontinuedToetsingOnlineon July 1, 2025. TheResearch Portal,launched in February 2025, became the sole platform for submitting medical scientific research tothe Central Committee on Research Involving Human Subjects (CCMO). This includes studies underthe Medical Research Involving Human Subjects Act (WMO), Embryo Law, Medical Device Regulation(MDR), In Vitro Diagnostic Regulation (IVDR), and non-WMO research. Clinical trials with medicinalproducts continue via CTIS. The S tate of Clinical Trial Transparency:2025 Developments and 2026 P redictions Asia Taiwan’s International Research-based Pharmaceutical Manufacturers Association (IRPMA)Post-Marketing Study Registry was discontinued on Jan. 1, 2025, following an October 2024Code ofPracticerevision. Post-marketing studies still require IRB review and medical director approval, butregistry submission is no longer required. Records registered before Jan. 1, 2025 remain accessible. Japanmigrated four clinical research systems on April 1, 2025: Japan Registry of Clinical Trials(jRCT), Clinical Research Review Board Information (JCRB), Ethics Review Committee ReportingSystem, and Clinical Research Information Portal, from National Institute of Public Health servers(.niph.go.jp) to Ministry of Health, Labour and Welfare servers (.mhlw.go.jp). India’sClinical Trial Registry (CTRI)introduced new requirements in September 2025, includingethics committee approval dated within one year at registration and a Declaration of Responsibilityconfirming no prior participant enrollment. CTRI also published a formal standard operatingprocedure (SOP) for modifying registered trials. Indonesiacompleted its registry platform migration in 2025, transitioningINA-CRRfrom ina-crr.id to ina-crr.kemkes.go.id. Dual submission was permitted until April 30, 2025, after which allsubmissions moved to the new platform. Migration concluded in September. China’sInternational Traditional Medicine Clinical Trial Registrylaunched an AI-enabledregistration tool in September 2025, incorporating intelligent content parsing, multilingualtranslation, and automated verification. In parallel, Brazil’sBrazilian Clinical Trials RegistryReBEC, managed by Fiocruz, launched Rebec@ in March 2025, the world’s first generative AIassistant aligned with ICTRP guidelines. These updates reflect a global trend toward AI-drivenregistry automation. Oceania TheAustralian New Zealand Clinical Trials Registry (ANZCTR)implemented enhanced registrationrequirements in March 2025, including multi-factor authentication and improved workflow guidance.In October 2025, ANZCTR announced a prioritization framework:AustralianandNew Zealandtrialsfirst, followed by trials from countries without WHO primary registries, then trials from countries withexisting WHO primary registries.