Citeline临床试验披露成熟度模型的运作模式和治理领域

Operating Model andGovernance Domainofthe Clinical Trial DisclosureMaturity Model Operating Model and Governance Domainof the Clinical Trial Disclosure Maturity Model Executive summaryThe operating model and governance domain making processes•Enables effective resource allocation andprioritization•Facilitates adaptation to changing regulatoryrequirements•Supports a culture of transparency and ethicalconduct are central components of the clinical trialdisclosure maturity model. They encompass theorganizational structure, policies, and processesguiding and controlling disclosure activities.A robust operating model and governanceframework ensures that clinical trial disclosureis managed effectively and consistently andcomplies with regulatory requirements. This element focuses on defining the overallgovernance structure, including executivesponsorship, steering committees, and decision-making authorities for disclosure policies andstrategies. Why this domain mattersThe operating model and governance domain is core to an organization’s clinical trial disclosureefforts. It defines how disclosure activities arestructured, managed, and overseen across theorganization. By establishing a clear frameworkfor decision-making and accountability, thisdomain empowers organizations to meet theirdisclosure obligations efficiently and effectivelyin an ever-evolving regulatory landscape:•Ensures consistent and compliant disclosure The consequences of a weak approach tooperating model & governanceA poorly structured operating model and governance framework for clinical trialdisclosure can undermine an organization’sability to meet its transparency obligationseffectively. With clear decision-makingprocesses, well-defined roles, and robustoversight mechanisms, sponsors can maintainconsistency and compliance across their practices across the organization•Provides clear accountability and decision- Operating Model and Governance Domainof the Clinical Trial Disclosure Maturity Model but may not cover all disclosure and data-sharing aspects. The strategy is reactiverather than proactive, and a summary of thetransparency policy is not publicly available.•Leading:Comprehensive, well-documenteddisclosure policy and strategy are in place,regularly reviewed, and fully integrated intoorganizational processes. A summary of thetransparency policy is made public. disclosure activities. Lacking structuredgovernance can lead to inefficiencies,compliance gaps, and difficulty adapting toevolving regulatory requirements, ultimatelyimpacting the organization’s reputation andstakeholder trust. Specific risks include:•Uncoordinated disclosure across registries, potentially exposing confidential informationand jeopardizing patent applications•Missed regulatory deadlines due to unclearresponsibilities•Inefficient use of resources and duplication ofefforts•Increased risk of noncompliance withdisclosure requirements•Difficulty in adapting to new regulations orbest practices•Lack of organizational commitment totransparency The main components of disclosure policies andstrategies are:•Clear statement of commitment to transparency•Defined scope of disclosure and data sharing(e.g., which trials, what information, and atwhat time)•Guidelines for handling company confidentialinformation (CCI) and personal data•An approach to voluntary disclosure beyondregulatory requirements•Procedures for responding to disclosure-related requests and inquiries Key elements of the operating model &governance Policies/disclosure strategyComprehensive policies and strategies are the Organizational alignment*The organizational alignment for clinical foundation of a practical clinical trial disclosureapproach. They provide a clear frameworkfor decision-making, ensure consistencyacross the organization, and demonstratecommitment to transparency. Well-developedpolicies and strategies guide all aspects ofdisclosure, from determining what informationto share and when to outlining the processesfor ensuring regulatory compliance. They alsohelp organizations navigate complex scenarios,such as balancing transparency with protectingproprietary information. trial disclosure varies across sponsors but isessential in effective disclosure management.While there’s no one-size-fits-all approach, thedisclosure function is typically housed withinmedical writing, clinical operations, or regulatoryaffairs. The structure often depends on the sizeof the organization and its trial portfolio. Maturity levels:•Lagging:Disclosure responsibilities are assigned to individuals with limited clinicaltrial data disclosure expertise. These peopleoften struggle to gain support from clinicalteams and executive management. ContractResearch Organizations (CROs) and affiliatesprimarily handle disclosure activities atthe local level, with minimal coordinationacross different registries and jurisdictions.This fragmented approach leads to contentinconsistencies and potential compliance risks. Th