Sharing Clinical Trial Reports and Data Access – Some practicalities Merete Jørgensen 26 May 2014 DSBS Hillerød

Data Sharing and Management Snafu in 3 Short Acts Sharing Clinical Trial Reports and Data Access26 May

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 May 2014Sharing Clinical Trial Reports and Data Access 3

Publicly available information from trials - before 1 March 2014 Scientific journalNovoNordisk-Trials.comClinicalTrials.gov Sharing Clinical Trial Reports and Data Access26 May

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 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 Granting access to patient-level data 5

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

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 – Trial background App – Patient listings App – Completed CRFs App – 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 – Exclude !App – Exclude !App – Exclude !App – Exclude Sharing Clinical Trial Reports and Data Access26 May

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

Redaction Tools Sharing Clinical Trial Reports and Data Access26 May

Apply redaction Sharing Clinical Trial Reports and Data Access26 May

Apply redaction based on search pattern Sharing Clinical Trial Reports and Data Access26 May

Update of NovoNordisk-trials.com 26 May 2014Sharing Clinical Trial Reports and Data Access 12

26 May 2014 Add information on the trials for which CSRs are available Sharing Clinical Trial Reports and Data Access 13

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

Finding the redacted reports 26 May 2014Sharing Clinical Trial Reports and Data Access 15

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

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

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

Data Access Frontend 26 May 2014Sharing Clinical Trial Reports and Data Access 19

Independent Review Board 26 May 2014Sharing Clinical Trial Reports and Data Access 20

Data access solution Sharing Clinical Trial Reports and Data Access26 May Transparency System Independent Review Panel Request Web

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

Thanks to a lot of Novo Nordisk people for sharing their slides 26 May 2014Sharing Clinical Trial Reports and Data Access 23