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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 Data from BMS-sponsored global interventional clinical trials that are published on ClinicalTrials.gov are available for external data requests.*

*Data from phase I trials in healthy volunteers and consumer health care studies are considered out of scope.
When Studies are Available for Sharing In general, data from trials that meet the above criteria are made available for request approximately 18 months after clinical trial completion.
Exceptions While Bristol Myers Squibb is committed to data transparency, there are specific circumstances under which data may not be shared—even if a study meets general eligibility criteria. These include:

  • Clinical trials involving rare diseases or conducted at a single center may pose a reasonable likelihood of participant re-identification.
  • Data sharing may be prohibited by the informed consent form, or restricted due to regulatory, legal, contractual, or other limitations.
  • Limitations such as incompatible database formats, co-development with external entities, or documentation not available in English may prevent data sharing.
  • Studies with active regulatory submissions or pending publications may be withheld until those activities are complete.
  • If a data request conflicts with BMS’s publication plans, it may be declined.
  • Clinical trials subject to ongoing regulatory or legal restrictions on data sharing that would limit our ability to share the study. Requests for such studies will be considered on a case-by-case basis

Additionally, Bristol Myers Squibb does not generally share imaging data (e.g., DICOM files from x-rays, ultrasounds, MRI scans). Requests for such data will also be considered individually.

Bristol Myers Squibb reserves the right to update and revise these criteria at any time.
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 datasets are provided by default. No raw data will be provided.

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

  • IPD ACCESS: Individual Patient Data
  • Redacted SAP/PROTOCOL (If available)
  • Data Dictionary (if available)
  • Clinical Study Reports (CSR) (If available)
  • Annotated Case Report Forms (CRF) (If available)

Protocol/Statistical Analysis Plans are available on the ClinicalTrials.gov public registry for completed trials that have results published and can be accessed via the NIH website.
Questions or enquiries Enquiry form
Review Criteria for Data Requests Consistent with expectations of good scientific practice, researchers can request access to data from our studies by providing a research proposal with a commitment to publish their findings. The research proposal is reviewed by an independent review panel. This is a team of external independent experts.
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 IRP 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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