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

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

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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

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Publicly available information from trials - before 1 March 2014

Scientific journal NovoNordisk-Trials.com ClinicalTrials.gov

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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

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Redaction Tools

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Apply redaction

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Apply redaction based on search pattern

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Update of NovoNordisk-trials.com

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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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• Finding the redacted reports

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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

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Review Board

Data Access Requests

Data to be made available

System for Data Access

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Novo Nordisk Data Sharing Process

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Request website Independent Review Board Data access system

Data Sharing Agreement

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Data Access Frontend

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Independent Review Board

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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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• Thanks to a lot of Novo Nordisk people for sharing their slides

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