||We are a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
|How we share on the Vivli Platform
||To obtain Bristol Myers Squibb data, requestors must complete a data request on the Vivli platform. If the request is approved, Bristol Myers Squibb will upload the anonymized data into the Vivli platform for use by researchers or another platform in situations where the data cannot be shared in Vivli.
|Studies Listed for Sharing
||We consider requests to share clinical trial data from our in-scope Phase I-IV interventional trials in patients that have completed on or after January 1, 2008 and meets our criteria for sharing after assessment of patient privacy, informed consent, and regulatory standards.
|When Studies are Listed
||Bristol Myers Squibb will consider requests for sharing anonymized data from:
- Clinical trials that completed after January 2008.
- Clinical trials that are part of a program where Bristol Myers Squibb currently has the legal right to develop and commercialize the asset.
- Clinical trials that are part of a program approved for marketing or a terminated program and two years have elapsed since study completion or termination of the program.
|What information will be provided
||All information must be anonymized and redacted. Information that may be considered for disclosure includes information from:
- patient-level clinical data (raw and derived);
- study-level clinical data (raw and derived);
- Clinical Study Reports (CSR);
- annotated Case Report Forms (CRF) or documents explaining data structure;
- Statistical Analysis Plans (SAP); and
|Questions or enquiries
|Review Criteria for Data Requests
||In-scope proposals are sent to an Independent Review Committee (IRC) to review and provide the final decision on the requests. Bristol Myers Squibb has established a relationship with Duke University through the Duke Clinical Research Institute (DCRI) to act as that IRC. The IRC ensures that qualifying requests for patient-level data have a complete, consistent and fair assessment. They also review the proposal with the research team and discuss any clarifying questions that would better support the decision on the proposal. The IRC membership represents three broadly defined areas of expertise: clinical, statistical and bioethical/protection of human subjects. They also contract with additional experts depending on the request, therapeutic area, or other relevant factors.
|Data Request Review Process
||Internal Bristol Myers Squibb personnel will initially review each request to ensure alignment with the scope of the policy and check current or expected availability of the data sets. Following the initial review, a request will be submitted to the IRC for final review and decision.
|Access to study documents without participant-level data
||Access to study documents without participant level data will also be considered for sharing. Requests for this information can be initially submitted using the inquiry form. A full research proposal may be required before access is provided.
||All data must be anonymized to protect the privacy of the patients who participated in Bristol Myers Squibb sponsored studies, in accordance with applicable laws and regulations, and in compliance with the International Conference on Harmonization and Good Clinical Practice (ICH/GCP).
|Clinical Study Register or Website
||BMS will post study information on local, national or regional databases in compliance with national and international standards for disclosure.