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Sharing Clinical Trial Reports and Data Access – Some practicalities Merete Jørgensen 26 May 2014 DSBS Hillerød
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Data Sharing and Management Snafu in 3 Short Acts http://www.youtube.com/watch?v=N2zK3sAtr-4 Sharing Clinical Trial Reports and Data Access26 May 2014 2
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Data Sharing commitment Access to results summaries Sharing results with trial participants Certifying commitment publicly Commitment to publish results EFPIA & PhRMA Joint Principles – 1 Jan 2014 26 May 2014Sharing Clinical Trial Reports and Data Access 3
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Publicly available information from trials - before 1 March 2014 Scientific journalNovoNordisk-Trials.comClinicalTrials.gov Sharing Clinical Trial Reports and Data Access26 May 2014 4
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Our new Code-of-Conduct from 1 March 2014 Sharing Clinical Trial Reports and Data Access26 May 2014 Clinical Study Reports (CSRs) for trials completed after 1 January 2006 will be made available via www.novonordisk-trials.com. www.novonordisk-trials.com. Publishing clinical study reports CSRs for indications approved in US and EU will be published without appendices and will be redacted to remove patient and site- identifiable information. Access will be Governed by Independent Review Board (IRB) Based on research proposals, pre-defined protocols and statistical analyses plans Subject to publication rules and agreement to respect private and commercial confidentiality Novo Nordisk will grant researcher access to anonymised patient-level data from trials completed after 2001. Granting access to patient-level data 5
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Availability of Clinical Reports - To Consider Sharing Clinical Trial Reports and Data Access Scope of Reports – when and how much 26 May 2014 Redaction principles Software to use for redaction Detailed proccesses and approvals To be made available – from where 6
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CTR vs. redacted public CTR CTR structure (ICH E3): Sec. 1: Title page Sec. 2: Synopsis (separate document) Sec. 3-12: Report text (data- independent and data dependent) Sec. 13: Discussion and overall conclusions Sec. 14: End-of-text material (statistical tables (analyses and summaries), figures and listings); individual patient narratives Sec. 15: References App. 16.1 – Trial background App. 16.2 – Patient listings App. 16.3 – Completed CRFs App. 16.4 – Raw data listings Public CTR: Sec. 1: Include Sec. 2: Include – with appropriate redaction for PPD Sec. 3-12: Include – with appropriate redaction for PPD and CCI Sec. 13: Include Sec. 14: Include – except listings with individual data, individual subject profiles (e.g. PK) and individual narratives Sec. 15: Include !App. 16.1 – Exclude !App. 16.2 – Exclude !App. 16.3 – Exclude !App. 16.4 – Exclude Sharing Clinical Trial Reports and Data Access26 May 2014 7
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Personal identifiers (names, ids) Company Confidential Information Site ids Dates Verbatim text related to individuals All Narratives Never more than 2 indirect identifiers for an individual Redaction principles 26 May 2014Sharing Clinical Trial Reports and Data Access Slide no 8
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Redaction Tools Sharing Clinical Trial Reports and Data Access26 May 2014 9
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Apply redaction Sharing Clinical Trial Reports and Data Access26 May 2014 10
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Apply redaction based on search pattern Sharing Clinical Trial Reports and Data Access26 May 2014 11
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Update of NovoNordisk-trials.com 26 May 2014Sharing Clinical Trial Reports and Data Access 12
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26 May 2014 Add information on the trials for which CSRs are available Sharing Clinical Trial Reports and Data Access 13
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For this initial period the CSRs that is made available will be listed on this page The list will be updated regularly A more sustainable solution will be implemented Design of information on CSRs available 26 May 2014 New text added List updated ‘monthly’ Sharing Clinical Trial Reports and Data Access 14
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Finding the redacted reports 26 May 2014Sharing Clinical Trial Reports and Data Access 15
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Redaction Principles Supporting Guidance – more details Guide for use of Redaction tool Examples of redaction in practice SOPs – Process descriptions Sharing Clinical Trial Reports and Data Access26 May 2014 16
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Data Sharing - To Consider Sharing Clinical Trial Reports and Data Access Request for Access – Frontend 26 May 2014 Review Board Data Access Requests Data to be made available System for Data Access 17
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Novo Nordisk Data Sharing Process 26 May 2014 Request website Independent Review Board Data access system Data Sharing Agreement Sharing Clinical Trial Reports and Data AccessSlide no 18
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Data Access Frontend 26 May 2014Sharing Clinical Trial Reports and Data Access 19
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Independent Review Board 26 May 2014Sharing Clinical Trial Reports and Data Access 20
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Data access solution Sharing Clinical Trial Reports and Data Access26 May 2014 21 Transparency System Independent Review Panel Request Web
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Recoding of IDs Blanking of all verbatims Offsetting of dates Age/max age/age category considerations Grouping of sites/countries if less than … subjects Grouping of countries to continents Raw-level de-identification of rare events, socio-economic data, use of illicit drugs information De-identification 26 May 2014Sharing Clinical Trial Reports and Data Access 22
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Thanks to a lot of Novo Nordisk people for sharing their slides 26 May 2014Sharing Clinical Trial Reports and Data Access 23
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