Clinical Data Sharing with Researchers: Status Report - Applied Clinical Trials

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Clinical Data Sharing with Researchers: Status Report

Source: Applied Clinical Trials

Clinical Data Sharing with Researchers: Status Report

After Bayer and Boehringer Ingelheim announced their use of ClinicalStudyDataRequest.com as their request portal for clinical data sharing with researchers, we posted this article. This week, Eli Lilly announced its intention to join ClinicalStudyDataRequest.com.

We compiled a list of how sponsors offer access to patient level clinical data requests from researchers. This week, also, Forbes posted this list for the Top 12 Pharma ranked by 2013 market capitalization on their data available for sharing.

This list was based on the author’s fuller article linked here on all data sharing parameters for the Top 6 Pharma, Ranked by 2013 Market Capitalization.

 

Company                               Request Type                                 Request Review

*AbbVie

Internal email request

Internal review, with appeal independent external board for final decision

Amgen

Internal email request

Internal review, and “as appropriate” independent external advisors

 

*^AstraZeneca

Not posted. “consider requests on a case-by-case basis”

 

*^Bayer

Shared portal www.clinicalstudydatarequest.com

Independent centralized review panel

Biogen Idec

Internal email request (developing a request/approval portal)

Not posted

Boehringer Ingelheim

Shared portal www.clinicalstudydatarequest.com

Independent centralized review panel

*Bristol Myers Squibb

Internal request portal

External scientific review provided by DCRI faculty members.

^Celgene

Internal email request

External Scientific Review Board

*Eli Lilly

Shared portal www.clinicalstudydatarequest.com

Independent centralized review panel

EMD Serono

Not posted

 

External scientific review board

*GlaxoSmithKline

Shared portal www.clinicalstudydatarequest.com

Independent centralized review panel

*^Janssen Pharma

Internal request portal

External review provided by Yale School of medicine’s Open Data Access Project (YODA).

Lundbeck

Not posted. “Lundbeck and a third party will be subject to a formal agreement that will address ownership and access to data.”

Specific criteria listed on site

*Merck

Internal email request

Internal review, external review board as needed

*Novartis

Shared portal www.clinicalstudydatarequest.com

Independent centralized review panel

Novo Nordisk

Internal email request

Independent review board, data access granted within a web-based system.

Otsuka

Not yet developed.

Not yet developed.

*^Pfizer

Internal request portal

Independent review panel

Purdue Pharma

Not posted; PhRMA-certified to following joint principles.

 

*Roche

Shared portal www.clinicalstudydatarequest.com

Independent centralized review panel

*^Sanofi

Shared portal www.clinicalstudydatarequest.com

Independent centralized review panel

Takeda

Not posted; PhRMA-certified to following joint principles.

 

Source: Applied Clinical Trials compilation of company web site data, June 30, 2014.

 

*Top 12 Pharma ranked by 2013 market capitalization

^ Companies affiliated with Project DataSphere for oncology data sharing.

 

 

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