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

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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

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 Process26 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 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

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

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