Life Science Compliance Update

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June 27, 2014

Clinical Trial Transparency Update: Eli Lilly, Bayer, Boehringer, and BMS Join Pharmaceutical Companies Sharing Patient-Level Clinical Trial Data

Eli Lilly, Bayer Healthcare, and Boehringer Ingelheim have announced their plans to increase access to their clinical trial data. All three are using the website ClinicalStudyDataRequest.com (which currently is down until July 1st) to share clinical study reports and de-identified patient-level data with researchers upon request. They will join GlaxoSmithKline, Novartis, Roche, Sanofi, and ViiV Healthcare, who also use the same portal to manage data requests. Separately, Bristol-Myers Squibb announced that they will be collaborating with Duke University to expand access to their trial data.

Clinical Study Data Request: How the database works

Clinical Study Data Request provides a secure internet portal for researchers to request patient-level anonymized clinical trial data provided by sponsor organizations.

After creating an account on the website, researchers can submit a single research proposal which is then reviewed by an independent review panel who decides whether access should be provided. The panel reviews the proposed science, publication plans, conflicts of interest and the qualifications of the research team. Following approval by the independent review panel, researchers are asked to sign a data sharing agreement.

Eli Lilly's announcement highlights the differences from previous data-sharing sites. "The new portal, www.clinicalstudydatarequest.com, differs…in that access will only be granted after approval of a research proposal by an independent scientific review panel. Lilly will not be involved in the decisions made by the independent scientific review panel."

YODA Project

Medtronic and Janssen, the pharmaceutical company of Johnson and Johnson use Yale's Open Data Access (YODA) as the intermediary for clinical trial data requests. The YODA Project performs independent scientific reviews of investigator requests for Janssen's and Medtronic's clinical trial data, including both Clinical Study Reports and participant-level data.

Duke Clinical Research Institute

Bristol-Meyers Squibb on June 24 announced that they would expand their access to clinical trial data through a collaboration with Duke University.

PhRMA Principles for Responsible Clinical Trial Data Sharing

In January of this year, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) jointly created a new policy that sought to enhance public health through responsible sharing of clinical data. Companies that follow the policy certify that they have established policies and procedures to implement the data sharing commitments. The following list identifies the companies that have provided such certifications to PhRMA as of May 28, 2014:

Clinical Trial Transparency: List of Individual Company Information

Abbvie

Bayer Healthcare

Biogen

Bristol-Meyers Squibb (New- June 24, 2014)

Boehringer Ingelheim

Calgene

Eli Lilly

GlaxoSmithKline

Novartis

Novo Nordisk

Pfizer

Roche

Sanofi

Shire

Takeda

UCB

ViiV Healthcare

If we failed to list your company, please send us the link to your information and we will be glad to add it to this list.

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