为什么现在披露很重要：介绍Citeline临床试验透明度成熟度模型

Why Disclosure Matters Now:Presenting the Maturity Modelfor Clinical Trial Transparency Why Disclosure Matters Now: P resenting theMaturity Model f or Clinical Trial Transparency Clinical trial disclosure and transparencyhave become important considerations intoday’s biopharmaceutical landscape. Acomprehensive maturity model for clinicaltrial disclosure and transparency offersbiopharmaceutical companies a strategic toolto assess and enhance their practices in anincreasingly complex regulatory environment.This model becomes critical as the industryfaces intensifying scrutiny, expandingdisclosure requirements, and emerging trendsthat demand proactive management ofclinical trial transparency. Organizations mustnavigate a rapidly changing landscape, fromevolving global regulations to integrating newtechnologies. environment, it’s a strategic necessity.Stakeholders across the spectrum — regulators,patients, investors, and the public — aredemanding greater transparency in clinicalresearch. This intensified scrutiny elevates clear,accurate, and accessible disclosure of clinicaltrial data to a cornerstone of building trust. A surge in regulatory scrutiny and expandingscopeRegulatory bodies, including the US Food and Drug Administration (FDA) and theEuropean Union (EU) local health authorities,are taking a stricter stance on disclosurecompliance. Evidence of this shift lies inincreased inspections and the growing numberof countries that have published enforcementplans. Companies face potential penalties fornoncompliance with registration requirementson CTIS in the EU, jRCT in Japan, ClinicalTrials.gov in the US, and other registries. The scopeof disclosure itself is broadening as well. New The disclosure imperative in today’s clinicaltrial landscapeEnsuring reliable disclosure practices has evolved beyond a mere regulatory requirementfor clinical trial professionals. In today’s Why Disclosure Matters Now: P resenting theMaturity Model f or Clinical Trial Transparency registration. This aligns with the growingemphasis on open science and collaborativeresearch, where sharing data across institutionscan accelerate scientific discovery. Leadingbiopharmaceutical companies are taking thisfurther by launching transparency initiativesthat showcase their commitment beyondregulatory mandates. regulations and guidance documents nowrequire a wider range of information to bedisclosed, including patient-facing clinical trialdocuments and anonymized patient-level data. Beyond registries: a broader transparencyhorizon Initiatives such as the mandatory publicationof full clinical study reports and data-sharingplatforms demonstrate a push for transparencythat extends to more than just clinical protocol Recent developments and future trends: a callfor proactive action The past year has seen significant developmentsthat underscore the importance of proactivemanagement. Consider these key trends: documents and laws related to clinical trialdisclosure have been published, of whicharound 30% have already been superseded.This shows just how quickly the requirementsare evolving. Not only is it a challenge tofind these documents in the first place, buttracking/analyzing the changes is a full-timejob. •Constantly evolving requirements:Newand updated disclosure requirements arepublished continuously. For example, in thepast 12 months, over 130 regulatory guidance Why Disclosure Matters Now: P resenting theMaturity Model f or Clinical Trial Transparency the registries in the US (ClinicalTrials.gov), EU(CTIS), and possibly Japan (jRCT), it may beyears before most registries and sponsors adoptthis standard. •Expanding global requirements:To date,75 countries mandate clinical trial disclosureacross over 50 registries. This representsa significant expansion from two decadesago when only two registries required publicposting of protocols. Current disclosurerequirements have grown to encompass abroader range of clinical documents and data,including:-Full protocols With these growing and evolving requirements,a focus on pragmatic and cost-effectivedisclosure processes is crucial, where exploringtechnology solutions and streamlining workflowscan optimize resource allocation. -Clinical study reports (CSRs)-Anonymized patient data•Continued regulatory focus:Expect stricter The value of a maturity model: a roadmap forimprovement enforcement actions and penalties fornoncompliance with disclosure regulations.•Focus on patient-centric disclosure: A clinical trial disclosure maturity model isvaluable in this dynamic environment. Considerthe ever-increasing challenge of constantlyevolving requirements. New and updateddisclosure regulations are published frequently.Keeping track of these changes can be a full-time job, and failing to comply with the latestregulations can lead to penalties. Disclosure formats will likely become moreuser-friendly and accessible to lay audiences,catering to patient needs for clear and conciseinformation.•E