PhUSE Annual Conference, Barcelona 11. October 2016 Jean-Marc Ferran Consultant & Owner

Transcription

1 PhUSE Annual Conference, Barcelona 11. October 2016 Jean-Marc Ferran Consultant & Owner

2 Source: EMA Update, Sweeney & Alteri, CDISC European Interchange, Vienna, 27 April 2016

3 Study Results Public Disclosure Overview EudraCT and ClinicalTrials.gov Processes Policy 0070 AnonymizaRon Guidance Overview Conclusions

4 US Public Disclosure Database Study Results EffecRve SEP2008 Any Study part of an approved IND applicaron Inform public and trial parrcipants on core Results EU Public Disclosure Database Study Results EffecRve 20JUL14 Any Study with sites in Europe (EEA) & Studies in Children conducted outside EU but part of a PIP Inform public and trial parrcipants on core Results Part A CSR EffecRve 01JAN15 Any Study part of a Centralized MarkeRng AuthorizaRon applicaron Understand conclusions Policy 0070 Part B IPD EffecRve?????? Conduct secondarypurpose analyses, review data or verify results

5 5 IND not approved at study comple>on LPLV + 6/12 months Approval Approval + 30 days LPLV IND approved at study comple>on, Pediatric study LPLV LPLV + 6 months LPLV + 12 months IND approved at study comple>on, Adult study LPLV LPLV + 12 months

6 Source: haps://

7 Trial InformaRon Subject DisposiRon Baseline CharacterisRcs Purpose PaRent Flow Subject DisposiRon Baseline CharacterisRcs End Points Serious AE Non- Serious AE More InformaRon Outcome Measures Serious AE Other Events More InformaRon

8 PresentaRon Rtle Date 8

9 CSR Input SAS Code EUTCT SOC CODES AE Statistics ADAE Age Category Statistics ADSL Country Statistics Trial Information Subject Disposition Baseline Characteristics End points More Information Output AE Summary Report AE XML Age Category Report Country Report EudraCT Report Trial Information Adverse Events Trial Information

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12 CSR Input Study Metadata SAS Code Analysis Results Metadata ADaM More Information Verify other uploaded sections? Summary Results Output Public Disclosure Management System Trial Info. Reports AE Summary Report Subject Disposition Reports Baseline Charact. Reports End Points Reports Public Disclosure XML Trial Information Subject Disposition Baseline Characteristics End points Adverse Events CSR 12

13 Source: EMA Update, Sweeney & Alteri, CDISC European Interchange, Vienna, 27 April 2016

14 CDISC CTR-XML Specifica>on, version 1.0 released on 28MAR2016 Clinical Trial registry submissions to WHO, EudraCT registry and ClinicalTrials.GOV Protocol schema that can be implemented in Sofware HarmonizaRon with TransCelerate protocol work Summary results data elements CollaboraRon with the PhUSE RDF Working Group Source: CTR Update, Paul Houston, CDISC European Interchange, Vienna, 28 April 2016

15 Sponsors Publica>ons Based on Pseudomized IPD Forever Sponsors choice No AnonymizaRon Public Domain Sponsors Data Transparency Ini>a>ves Anonymized IPD Started in 2013 with GSK Any Study related to an approved applicaron in EU & US Safe-Harbor or Average Risk Metrics May result in PublicaRons available in Public Domain Part A Anonymized CSR Portal go-live SEP2016 Any Study part of a Centralized MarkeRng AuthorizaRon applicaron QualitaRve or Maximum Risk Metrics Semi-Public Domain Policy 0070 Part B Anonymized IPD Effec%ve?????? Average or Maximum Risk Metrics? Public Domain or Controlled? PublicaRons available in Public Domain

16 Recommends using the PhUSE DeID standard Focus on Data URlity must be demonstrated AnonymizaRon Report is made public Sponsor remains Data Controller LisRngs not in scope of Part A Available Public Data and Technology may evolve NarraRves must be anonymized Guidance 2. March 2016 Conclusions must be similar

17 Listings Pseudomized Raw Pseudomized SDTM+ Pseudomized Safety Database Pseudomized & Derived Narratives Pseudomized & Aggregated Scientific CSR SDTM ADaM TFLs Anonymized CSR Listings Selected TFLs Pseudomized Raw Pseudomized SDTM+ Anonymized Safety Database Anonymized & Derived Narratives Anonymized & Aggregated Anonymized CSR SDTM ADaM TFLs

18 Restricted Public Domain Risk? (Anonymized) SDTM/ADaM (Anonymized) CSR Risk? (Anonymized) PublicaRon 1 Risk! (Anonymized) PublicaRon 2

19 Can we expect Regulatory Agencies to align or even integrate such requirements? Probably not fully but to some extent yes Different legal environments Large difference in resources Global data models for protocol and results summary will be required to ensure interoperability and reuse EMA CSR AnonymizaRon Guidance is srll being interpreted by a number of industry groups and companies and a number of solurons should emerge in the coming year

20 Jean-Marc Ferran Consultant & Owner, Qualiance ApS