|Articles|June 3, 2014

Clinical Data Sharing with Researchers: Status Report

We compiled a list of how sponsors offer access to patient level clinical data requests from researchers.

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
Internal email request
Internal review, with appeal independent external board for final decision
Internal email request
Internal review, and “as appropriate” independent external advisors
 
Not posted. “consider requests on a case-by-case basis”
 
Independent centralized review panel
Internal email request (developing a request/approval portal)
Not posted
Independent centralized review panel
Internal request portal
External scientific review provided by DCRI faculty members.
Internal email request
External Scientific Review Board
Independent centralized review panel
Not posted
 
External scientific review board
Independent centralized review panel
Internal request portal
External review provided by Yale School of medicine’s Open Data Access Project (YODA).
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
Internal email request
Internal review, external review board as needed
Independent centralized review panel
Internal email request
Independent review board, data access granted within a web-based system.
Not yet developed.
Not yet developed.
Internal request portal
Independent review panel
Purdue Pharma
Not posted; PhRMA-certified to following joint principles.
 
Independent centralized review panel
Independent centralized review panel
 
Not posted; PhRMA-certified to following joint principles.
 
 
Shared portal
www.clinicalstudydatarequest.com
                              Independent centralized review panel                                                                                          
Source: Applied Clinical Trials compilation of company web site data, June 30, 2014.
 
*Top 12 Pharma ranked by 2013 market capitalization
 
 

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