Center for Global Research Data
Our Members
Purdue Pharma L.P.
| About | Purdue Pharma L.P. (“Purdue”) manufactured a portfolio of pharmaceutical products, including certain opioid products for pain management. As part of Purdue’s emergence from bankruptcy, it agreed to be bound by an Operating Injunction that includes a clinical trial data transparency provision pertaining to Butrans®, Hysingla® ER, and OxyContin®. Knoa Pharma LLC now distributes these products. |
| How we share on the Vivli Platform | Purdue studies that are available for data sharing are listed on Vivli. Data requesters should use the Vivli Data Request Form to request data package(s). If the request is approved, Privacy Analytics will upload the documents and data to the Vivli Platform. |
| Studies Listed for Sharing | Clinical trial data for Butrans®, Hysingla® ER, and OxyContin®. |
| When Studies are Available for Sharing | Clinical trial data will be shared in response to a request from a researcher after the Independent Review Panel determines that the researcher is qualified, the proposal seeks data for a bona fide scientific purpose, and the request is complete. |
| Additional Conditions for Access | A Data Use Agreement (DUA) with the researcher must be executed prior to the researcher being able to access data within the Vivli platform. |
| What Information Will be Provided | Anonymized clinical trial data and other information, such as protocols, clinical study reports, and statistical analysis plans. |
| Questions or Enquiries | Please contact support@vivli.org. |
| Review Criteria for Data Requests | Access to data will be granted to any qualified researcher with a bona fide scientific research proposal. |
| Data Request Review Process | Proposals that have been received via Vivli will be reviewed for scientific merit by the Independent Review Panel according to its charter. |
| Access to Study Documents Without Participant-Level Data | For certain studies, access to the Clinical Protocol and Statistical Analysis Plan are available to Vivli users without request. |
| Anonymization Standards | Prior to sharing, clinical trial data is anonymized or redacted in accordance with applicable laws and regulations. |
| Clinical Study Register or Website | https://www.purduepharma.com |