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Bristol Myers Squibb

 

About 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 for use by researchers.
Anonymization Standards

All data provided through the Vivli platform will be anonymized in accordance with applicable laws and regulations, and in compliance with the International Conference on Harmonization and Good Clinical Practice (ICH/GCP).

The following data protection procedures for personally identifiable information are performed by Bristol Myers Squibb prior to data sharing:

  • Participant ID: Replaced (pseudonymized) by new ID consistently across all datasets to keep the patient-record relationship.
  • Further unique identifiers: Removal of identifiers not required for linking datasets e.g., names, initials, device numbers.
  • Site ID: Removed.
  • Date of birth: Removed.
  • Age: Generalize age to 5-year groups, and aggregation of age > 89.
  • Race: Aggregate races with fewer than 10 participants to “Other”.
  • Ethnicity: Removed.
  • Country: Removed if the data includes a region variable. Otherwise, aggregation of country to continent level.
  • Dates/Times: Dates are PHUSE shifted by a number of days. The same shift is used across dates for a given participant, however different shifts are used for different participants. Times remain unchanged.
  • Dictionary term of adverse events and medical history: Unique coded dictionary terms are removed.
  • Dictionary term of concomitant medications: Unique coded dictionary terms are removed.
  • Comments, free text, and verbatim terms: Removed
  • Genetic data: Removed, unless requested.
Studies Considered for Sharing We consider requests to share clinical trial data from our in-scope Phase II-IV interventional trials in patients that have completed on or after January 1, 2008. In addition, primary results from these trials must have been published in peer-reviewed journals and the medicines or indications approved in the U.S., EU, and other designated markets. Sharing is also subject to protection of patient privacy and respect for the patient’s informed consent.
Exceptions
  • Data considered for sharing may not include identifiable patient-level data.
  • Requests for ongoing clinical trials will be reviewed case by case.
  • Bristol Myers Squibb reserves the right to update and change criteria at any time
When Studies are Available for Sharing Bristol Myers Squibb will consider requests for sharing anonymized data from:

  • Clinical trials that completed on or after January 1, 2008.
  • Clinical trials with primary trial results published in a peer-reviewed journal
  • Clinical trials with results disclosed in public registries
  • Clinical trials that are part of a program for medicines or indications approved by US, EU and other designated markets or a terminated program
  • Clinical trials that are part of a program where Bristol Myers Squibb currently has the legal right to develop and commercialize the asset.
What information will be provided Clinical trial data and related documents made available through the Vivli platform will be redacted to remove confidential information anonymized to protect the privacy of trial participants.

Anonymized derived datasets are provided by default. SDTM can be specifically requested by the researcher in the request. No raw data will be provided.

Information from eligible trials that may be considered for disclosure upon request includes:

  • Patient-level clinical data (derived);
  • Study-level clinical data (derived);
  • Clinical Study Reports (CSR);
  • Annotated Case Report Forms (CRF);
  • Statistical Analysis Plans (SAP); and
  • Protocols
Questions or enquiries Enquiry form
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 listed above without participant level data will also be considered for sharing. Requests for this information can be initially submitted using the enquiry form. A full research proposal may be required before access is provided.
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.
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