EU Connect 2018, Frankfurt 5. November 2018 Jean-Marc Ferran Consultant & Owner
Brief Overview • Comparisons of the 3 Initiatives • – Engaging Stakeholders – Processes – Anomymization Requirements In Practice • – EMA Policy, 2 years on – Health Canada Draft Process – Focus on FDA approach – Recognition Process? Conclusions •
Industry Pilots Policy 0070 Policy 0070 Phase1 Policy 0070 Policy 0070 Roundtables External TAG 1st Draft Phase1 Guidance 2012 2013 2014 2015 2016 2017 2018 2019 2008… White Paper Draft Guidance Draft Policy Stakeholders Group
Item EMA Health Canada FDA Consultation on: Policy & Guidance Policy & Guidance Planned “public through Stakeholders through Public Review feedback through a Review Federal Register notice and docket for public comments” following the conduct of the pilots Pilot None None 9 pilots to be planned with sponsors Working Groups EMA TAG Stakeholders Group Not planned so far Working Groups Public call for Individual call for NA Application applications applications CV & DoI required Application Letter & DoI required Working Group Maximum 2 years 6 months between NA Mandate renewable October 2018 and April 2019 Working Groups Q&A, Additional Participation in 5 NA Deliverables Guidance, Critical Meetings to comment on Review (TBA) 5 key topics that led to developed by TAG the development of the members under EMA guidance by Health officers’ supervisions Canada officers.
Item EMA Health Canada FDA (Draft) (Pilot) Effective Date 1. January 2015 Not effective yet Not effective yet Retrospective access to Not in scope In scope, based on Not in scope past CSR prioritization system Possibility through Possibility through FOIA Sponsors conduct request Policy 0043. anonymization unless a certified EMA Policy 0070 Sponsors conduct the document is available. redactions. FDA conduct the redactions Documents are made Documents are sent to public. requester. Documents are sent to requester. Studies in Scope All studies part of a Central Step-wise approach over 4 Only Phase III pivotal Application regardless of years including Medical studies CSRs following submission outcome Devices studies from year 3 approval of an NDA regardless of submission ouctome Recognition Process with None has been Yes with EMA through a Not discussed other Agencies communicated so far certification application Review Process Using Annotated Documents Same as EMA but HC None but Sponsor can (Anonymization of PPD) and Anonymisation Report. validates de-identification of notify FDA of special- Opinion is provided. patient information and attention item in CSRs keeps decisions on what is publicly released.
Item EMA Health Canada FDA (Draft) (Pilot) Narratives in scope Yes Yes No Risk analysis WP29 Opinion 3-Criteria Quantitative only “Qualitative” based on FDA’s approach for FOIA request Qualitative Quantitative Anonymization Technique Anonymization & Redaction Anonymization Redaction only based on FDA’s approach for FOIA request. In particular, “ Demographic information, such as sex, age, and race, will generally not be redacted, except in very unusual circumstances” Indirectly - identifying variables Guidance on Identification of Refer to PhUSE Standard and Different type of identifiers Direct/Quasi Identifiers discuss in particular quasi are other identifying variables discussed in Q&A page: identifiers such as: that fall within the definition of Unique Patient Identifiers ‘personal information’ within Dates Dates Canada’s Privacy Act. And refer Geographic Location Clinical Trial Site Geographic to Demographics and medical Other Quasi-Identifiers (e.g. Location history and SAE. Demographics) Demographics Country should remain Relative dates (study days) are unmodified. retained Guidance on Reference No direct guidance but examples 4 populations are provided for NA Population of plausible attacks to consider consideration: for risk modeling are listed. • Study Population • Similar Sponsor Trials Population • Similar Trials Population • General Geographic Population
100+ Submission Packages published • • Sponsors still using in majoring qualitative approach coupled with redaction External Guidance updated 3 times, mainly for scope clarifications • Due to Business Continuity Plan in connection with Brexit, Policy 0070 is posed since • August 2018 Ref: Analysis of CSRs already published, PhUSE Review based on 47 submissions – Lukasz Kniola, November 2017
1 Pilot Published so far, Janssen Pharmaceutica / ERLEADA • • Narratives out of scope, redaction only according to FOIA approach Dates Subject ID Redacted redacted Age Kept Relative Dates Kept Family Gender Relationship Kept Kept Ref: “Drug Approval Package: ERLEADA” posted on FDA website, page 102, section 7.2.3.1 Deaths
?
EMA and Health Canada initiatives are very similar while FDA’s • differ significantly in anonymization requirements and processes – Will FDA consider anonymized CSRs already published in other jurisdictions when conducting redaction on same documents? And vice-versa? Use of Study Days in the CSRs could minimize the anonymization • effort and seems accepeted by all 3 agencies as anonymized dates The question of Joint Controllership should be clarified by all • agencies as they review, validate or conduct anonymisation or redaction of documents Three sources of same clinical documents could be available in • public domain. Which one will suit better the need of researchers? Recognition processes is only viable if there is an alignment of • anonymization requirements
Jean-Marc Ferran Consultant & Owner, Qualiance ApS dk.linkedin.com/in/jeanmarcferran/ @QualianceTwitta
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