Sharing Clinical Trial Reports and Data Access – Some practicalities Merete Jørgensen 26 May 2014 DSBS Hillerød.
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Sharing Clinical Trial Reports and Data
Access – Some practicalities
Merete Jørgensen26 May 2014
DSBS Hillerød
Data Sharing and Management Snafu in 3 Short Acts
• http://www.youtube.com/watch?v=N2zK3sAtr-4
Sharing Clinical Trial Reports and Data Access 26 May 2014 2
• 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
Publicly available information from trials - before 1 March 2014
Scientific journal NovoNordisk-Trials.com ClinicalTrials.gov
Sharing Clinical Trial Reports and Data Access 26 May 2014 4
Our new Code-of-Conduct from 1 March 2014
Sharing Clinical Trial Reports and Data Access 26 May 2014
Clinical Study Reports (CSRs) for trials completed after 1 January 2006 will be made available via 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
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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
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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
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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
Apply redaction based on search pattern
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26 May 2014
Add information on the trials for which CSRs are available
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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 addedList updated ‘monthly’
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• Redaction Principles
• Supporting Guidance – more details
• Guide for use of Redaction tool
• Examples of redaction in practice
SOPs – Process descriptions
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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
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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 Access Slide no 18
Data access solutionSharing Clinical Trial Reports and Data Access 26 May 2014 21
Transparency SystemIndependent 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
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