Citeline临床试验披露成熟度模型：卓越框架

The Clinical Trial DisclosureMaturity Model:A Framework for Excellence The Clinical Trial Disclosure Maturity Model:A Framework f or Excellence In today’s complex and highly regulated clinicaltrial landscape, ensuring robust disclosure andtransparency practices is more critical thanever. As stakeholders demand greater accessto clinical trial information, organizations mustestablish strong processes and governancestructures to meet these expectations whilemaintaining compliance and efficiency. This iswhere the clinical trial disclosure maturity modelcomes into play. Why a three-level model?We opted for a three-level model to streamline the assessment process and provide clearand actionable insights. This approach allowsorganizations to:•Quickly identify their current state across key domains•Focus on significant areas for improvementrather than incremental changes•Set clear, achievable goals for advancing theirmaturity level Understanding the maturity modelThe clinical trial disclosure maturity model The three levels are defined as:1.Lagging:Organizations at this level typically is a comprehensive framework designed tohelp organizations assess and improve theirdisclosure practices. Unlike the traditional five-level capability maturity model integration(CMMI), our model employs a simplified three-level maturity assessment: lagging, developing,and leading. have informal or inconsistent processes,limited oversight, and a reactive approach todisclosure requirements.2.Developing:At this stage, organizations have established basic processes and somelevel of governance but may struggle withconsistency or proactive management. The Clinical Trial Disclosure Maturity Model:A Framework f or Excellence 3.Leading:Organizations at this leveldemonstrate comprehensive, fully integratedprocesses, strong governance, and aproactive approach to disclosure andtransparency. how different-sized sponsors might approachthe model: Small sponsors (1–5 active trials)•Focus on foundational elements such as “policies & SOPs,” “data governance,” and“quality & compliance”•Emphasize “leadership engagement” to ensureorganizational buy-in•Aim for at least a “developing” level in coredomains while maintaining awareness of otherareas Key domains of the maturity modelIn this maturity model, a domain represents a distinct area of clinical trial disclosure practices,encompassing related processes, capabilities,and responsibilities that collectively contributeto an organization’s overall disclosure maturity.The model assesses maturity across eight keydomains: Medium sponsors (6–25 active trials)•Prioritize “quality & compliance,” “disclosure 1.Disclosure process management2.Quality & compliance3.Technology & systems4.Operating model & governance5.Data governance6.Reporting & metrics7.Training & awareness8.Organization process management,” “regulatorymonitoring,” and “data governance”•Invest in “technology & systems” and“reporting & metrics” to support growing datamanagement and reporting needs•Strive for a “leading” level in “regulatorymonitoring” and “disclosure processmanagement” Within each domain, elements are specificattributes or components that define relevantaspects of that domain, allowing for a moredetailed assessment of an organization’scapabilities and practices. Large sponsors (25+ active trials)•Aim for a “leading” level of maturity across all domains, given operational scale andcomplexity•Prioritize “technology & systems,” “reporting& metrics,” and “continuous improvement” todrive efficiency•Invest in “risk management” and “training& awareness” to ensure consistency acrossglobal operations These domains are interconnected, eachinfluencing the others to create a holistic viewof an organization’s disclosure maturity. Forexample, robust data governance supportseffective disclosure process management,enhancing quality and compliance. Similarly,advanced technology and systems can improvereporting and metrics capabilities, leading tobetter decision-making in the operating modeland governance domain. These guidelines should be adapted to eachsponsor’s unique circumstances, goals, and riskprofile. By considering the organization’s sizeand trial portfolio when applying the maturitymodel, sponsors can allocate resources moreeffectively for maximum impact. Tailoring the maturity model to the size of theorganizationWhile the clinical trial disclosure maturity It’s recommended for growing organizationsto reassess their maturity levels and adjustpriorities regularly. This ensures their disclosurepractices evolve in tandem with changing needs model provides a comprehensive approach,its application can be tailored based onorganizational size and trial portfolio. Here’s The Clinical Trial Disclosure Maturity Model:A Framework f or Excellence and regulatory requirements, maintainingcompliance and efficiency as they scale Benefits of the maturity modelImplementing the clinical trial disclosure maturity model can yield si