HEALTHCARE PROFESSIONALS

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 Information 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 (e.g., 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 (e.g., 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.

Request Clinical Trial Data

To request data from a clinical trial, please fill out and submit the form below. Please also read our Review Process for Data Sharing.

Expanded Access Program

Purdue Pharma is committed to advancing the medical care of patients with quality pharmaceutical products. We are known for our pioneering research in pain, a principal cause of human suffering. Today, we work with new partners on innovative healthcare solutions in many therapeutic areas.

In order for new medicines to be legally approved for use in patients, pharmaceutical companies, including Purdue, are required to evaluate the safety and efficacy of the investigational medicine in clinical trials and submit this data to the Food and Drug Administration (FDA). For most patients, the only way to access investigational medicines is to participate in clinical trials. To learn more about available clinical trials, visit clinicaltrials​.gov and search by company, disease, or medicine.

In rare cases when patients do not qualify for clinical trials and have exhausted all available treatment options, regulators may grant permission for Purdue to provide a treating physician with an unapproved medicine. Such individual use of an unlicensed investigational medicine is often called “compassionate use” or “expanded access” but may go by other names.

For information from the FDA about expanded access in the U.S., click here.

Who is eligible for Purdue’s Expanded Access Program?

All of the following criteria must be met in order to be considered for expanded access to Purdue’s investigational medicines:

1. The patient has a serious or immediately life-threatening disease or condition.
2. There is no comparable or satisfactory alternative therapy for the disease or condition, or the patient has undergone appropriate standard treatment without success.
3. The patient is ineligible for participation in any ongoing clinical study of the investigational medicine.
4. There is sufficient evidence or understanding of a potential patient benefit from the use of the investigational medicine to justify its potential risks.
5. The medicine must be part of an active and ongoing development process, and expanded access would not interfere within its development.
6. There is an adequate supply of the medicine to perform necessary clinical studies as well as provide expanded access.

Patients interested in expanded access to Purdue’s investigational medicines should speak to their physician.

How do I request expanded access for an investigational medicine?

If a treating physician believes expanded access may be the only option for a patient, the physician should contact Purdue Medical Information at 888-726-7535 press option 1 to make a formal request on behalf of the patient. Requests will only be considered if submitted by the treating physician. Alternatively, physicians may complete and submit the form below:

How are submitted requests evaluated?

Each request will be evaluated by medical experts at Purdue who are knowledgeable about the investigational medicine. We have a responsibility to the patient to weigh the potential benefit against the risks of the investigational medicine based on the information available at the time of the request. Each request will be evaluated fairly and carefully by our medical experts. The FDA must also approve the proposed use of the investigational medicine. Every effort will be made to respond promptly once we have all the necessary information.

Purdue, as used in this site, refers to Purdue Pharma L.P. and its subsidiaries, which includes Imbrium Therapeutics L.P., Adlon Therapeutics L.P. and Greenfield BioVentures L.P., Purdue Pharmaceuticals L.P. and Purdue Pharma Manufacturing L.P.