Sharing Clinical Trial Reports and Data Access – Some practicalities

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

2. Sharing Clinical Trial Reports and Data Access Data Sharing and Management Snafu in 3 Short Acts • http://www.youtube.com/watch?v=N2zK3sAtr-4

3. Sharing Clinical Trial Reports and Data Access EFPIA & PhRMA Joint Principles – 1 Jan 2014 • Data Sharing commitment • Access to results summaries • Sharing results with trial participants • Certifying commitment publicly • Commitment to publish results

4. Sharing Clinical Trial Reports and Data Access Publicly available information from trials- before 1 March 2014 Scientific journal NovoNordisk-Trials.com ClinicalTrials.gov

5. Sharing Clinical Trial Reports and Data Access Our new Code-of-Conduct from 1 March 2014 Publishing clinical study reports Granting access to patient-level data • Clinical Study Reports (CSRs) for trials completed after 1 January 2006 will be made available via www.novonordisk-trials.com. Novo Nordisk will grant researcher access to anonymised patient-level data from trials completed after 2001. • 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 • CSRs for indications approved in US and EU will be published without appendices and will be redacted to remove patient and site-identifiable information.

6. Sharing Clinical Trial Reports and Data Access Availability of Clinical Reports- To Consider Scope of Reports – when and how much Redaction principles Software to use for redaction To be made available – from where Detailed proccesses and approvals

7. Sharing Clinical Trial Reports and Data Access 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

8. Sharing Clinical Trial Reports and Data Access 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

9. Sharing Clinical Trial Reports and Data Access Redaction Tools

10. Sharing Clinical Trial Reports and Data Access Apply redaction

11. Sharing Clinical Trial Reports and Data Access Apply redaction based on search pattern

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

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

14. Sharing Clinical Trial Reports and Data Access Design of information on CSRs available • 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 New text added List updated ‘monthly’

15. Sharing Clinical Trial Reports and Data Access • Finding the redacted reports

16. Sharing Clinical Trial Reports and Data Access SOPs – Process descriptions • Redaction Principles • Supporting Guidance – more details • Guide for use of Redaction tool • Examples of redaction in practice

17. Sharing Clinical Trial Reports and Data Access Data Sharing- To Consider Request for Access – Frontend Review Board Data Access Requests System for Data Access Data to be made available

18. Sharing Clinical Trial Reports and Data Access Novo Nordisk Data Sharing Process Request website Independent Review Board Data access system Data Sharing Agreement

19. Sharing Clinical Trial Reports and Data Access Data Access Frontend

20. Sharing Clinical Trial Reports and Data Access Independent Review Board

21. Sharing Clinical Trial Reports and Data Access Data access solution Independent Review Panel Request Web Transparency System

22. Sharing Clinical Trial Reports and Data Access De-identification • 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

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