Review Process for Data Sharing

According to PhRMA’s Principles for Responsible Clinical Trial Data Sharing

Objective

In keeping with PhRMA’s Principles for Responsible Clinical Trial Data Sharing, this webpage describes the process by which Purdue Pharma L.P. (“Purdue”) will receive and review third-party research proposals and decide whether and how to provide data or other information (collectively, “Information”) to outside parties to facilitate scientific or medical research.

Scope

This process applies only to information from Phase 2, Phase 3, or Phase 4 clinical trials involving drug products and their approved uses in the United States that are currently or have been distributed by Purdue.

Information that may be provided includes study-level (aggregate) data, anonymized subject-level data, and study protocols, in accordance with stipulations specified within applicable informed consent forms.

Scientific Review Board

The Purdue Scientific Review Board (SRB) will adjudicate all requests for Information. The SRB will consist of Purdue employees selected by the Chief Medical Officer (CMO) from relevant departments, such as Research and Development, Medical Affairs, Law, and Ethics & Compliance, and two researchers or external experts who are not employees of Purdue. 

Request Process

Any requests for Information must be in conformance with PhRMA’s Principles for Responsible Clinical Trial Data Sharing. The request form (at upper left of this page) will be forwarded to Purdue’s Medical Services Department. The CMO or his/her delegate will issue a call for a meeting of the SRB within 30 days of receipt of a complete request.

At a minimum*, a complete request will contain the following:

  • Goals and objectives of the research
  • Rationale for research proposal
  • Qualifications and experience of the requestor and collaborators
  • The hypothesis being tested
  • A description of the Information being requested
  • The analysis plan, including statistical plan
  • The communication or publication plan
  • A complete disclosure of any potential conflicts of interest
  • The source(s) of all research funding, including in-kind (eg, non-clinical days)

As a condition of granting a request for Information, all researchers must agree in writing to the following stipulations:

  • The Information shall only be used for purposes approved by Purdue’s SRB.
  • The Information obtained shall not be transferred to or shared with any party not identified in this request.
  • All research conducted using the Information obtained from this request will be submitted for presentation at a scientific congress or/and publication in a peer-reviewed scientific or medical journal.
  • At least 10 business days prior to submitting any material related to this research for presentation or publication, including any written or verbal communications with print, broadcast or online media, the researcher(s) will allow Purdue to fact check and comment on the material.
  • The Information shall be deleted from all physical and electronic storage not later than three (3) years following publication/communication/dissemination of the research findings or upon researcher’s departure from institution where data are stored (eg, on a department/research center drive or cloud account), whichever occurs sooner.
  • The researcher(s) must agree that anyone with access to anonymized subject-level data/information will not attempt to defeat the data anonymization process.

*Depending on the nature of the Information request, more details may be required before a request will be considered to be a complete request.

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