Common Protocol Template (CPT) Initiative - CPT and Disclosure: Connecting Critical Processes
- 1. November 2017 CPT and Disclosure: Connecting Critical Processes
- 2. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * Clinical Trial Management Clinical Trial Supply Sample Management Data Capture Data Management Disclosure Report Compilation Investigator Payments The Information Flow Challenge 2 Protocol Therapeutic Area Libraries Clinical Data Standards Predictive Analytics inform inform structured information un/semi-structured information structured information The media break that exists between human-readable protocol concepts and the machine-readable (digital) information processed by clinical trial design & execution systems creates the need for frequent human interpretation.
- 3. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * Protocol MDR Metadata Repository Common Technical Document Statistical Analysis Plan Data Collection Clinical Trial Registry Clinical Study Report Tables, Listings, Figures Patient Datasets TOC Registry Results Protocol Development and Related Processes 3 Protocol development has become disconnected from critical related processes. Clinical Trial Registry Data Study-specific structured data Text Study-specific unstructured data Libraries Objectives/Endpoints Inclusion/Exclusion Data Standards Predictive Analytics
- 4. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * Common Protocol Template Enablers 4 The Technology Enabled Edition of the Common Protocol Template (CPT) avoids media breaks by capturing structured and unstructured information in variables available for export and reuse downstream. Common layout of content Libraries make model content available Information is captured in variables
- 5. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * The CDISC Clinical Trial Registry (CTR) Standard Extension of the SDM and ODM standards Enables the vision of an entirely digital protocol Creates an aligned set of fields Placed as structured information into the protocol Extracted to feed into a clinical trial registry 5 Clinical Trial Registry (CTR) Study Design Model (SDM) Operational Data Model (ODM)
- 6. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * CPT Disclosure Explained 6 Common Protocol Template CPT export generates a CT Registry data file Import CPT export generates either an Excel file to view the data or an XML file to directly import it into other systems to reuse in automated processes. CT Registry data can be used in other systems CPT Export In the Dec 2017 release, CPT variables are mapped to CDISC CTR standards where possible with the goal of providing incorporated fields for ClinicalTrials.gov, EudraCT, and WHO registries. CPT variables capture disclosure data per CDISC Clinical Trial Registry (CTR) Standards CDISC CTR standards set controlled terminology in a manner that harmonizes across ClinicalTrials.gov, EudraCT, and WHO registries
- 7. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * CPT and Disclosure to Trial Registries 7 CPT Dec 2017 Release CPT variables, mapped to CDISC CTR standard, capture protocol registry data required for ClinicalTrials.gov and enable export to XML and Excel. Instructional text embedded within Basic Word Edition guides authors to create registry-ready content. Future CPT Development Expand CPT variables to incorporate fields for EudraCT and WHO registries; Explore further use of CDISC CTR XML schema. Disclosure is integrated into protocol authoring Additions have instructional text to harmonize how registry information is captured in the protocol Next release of CPT Technology Enabled Edition includes variables aligned with required registry terms Improved quality and consistency
- 8. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * Number of Participants Enrollment Target Planned Number of Arms Arm Name Study Intervention Name Intervention Type IMP and NIMP Sourcing Packaging and Labeling Current Former Names Aliases Dosage Formulation Route of Administration Dosage Level Unit Dose Strength Primary Objective(s) Primary Endpoint(s) Secondary Objective(s) Secondary Endpoint(s) CPT Variables Available for Export Compound Number Protocol Number Protocol Title Protocol Short Title Acronym Approval Date Sponsor Name Sponsor Legal Address Agency ID Regulatory Agency Number Data Monitoring Committee Intervention Model Primary Purpose Study Phase Masking Tertiary Objective(s) Tertiary Endpoint(s) Sex of Participants Planned Minimum Age of Subjects Planned Maximum Age of Subjects Exclusion Criteria Medical Conditions Exclusion Criteria Prior Concomitant Therapy Exclusion Criteria Prior Concurrent Clinical Study Experience Exclusion Criteria Diagnostic Assessment Exclusion Criteria Other *Sponsor Status = Commercial *Trial Type = Interventional *Responsible Party = Sponsor *Healthy Volunteer = HLTSUBJ1 *These variables do not appear in template text but are included in export with values populated
- 9. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * Benefits 9 Benefits for Sponsors • Consistency of the information disclosed (information posted on websites and documents shared) • Effort focused on content review rather than cut & paste • Shorter time and reduced cost to create the disclosure information • Transparency considered during protocol development • Aligns with CDISC CTR Benefits to ClinicalTrials.gov • Increased quality on information disclosed on ClinicalTrials.gov • Timely information • Aligns with CDISC CTR Benefits for Investigators & Patients • Able to read consistent information regarding clinical trials • Defines trial information clearly across sponsors
- 10. Thank you