Data Sharing Request Process
Requests that are considered in-scope for sharing will meet the following criteria:
- Trials completed after January 2008.
- Trials that are part of a program where Bristol Myers Squibb currently has the legal right to develop and commercialize the asset.
- 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.
All data requests/proposals are reviewed internally by a qualified panel of Bristol Myers Squibb experts that are familiar with the data. The Bristol Myers Squibb team ensures the proposal is complete, the scientific request is valid, and that the data are available, consistent with safeguarding patient privacy and informed consent.
The 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.
DCRI will evaluate the proposal based on:
- Scientific rationale and methodology
- Experience and relevant qualifications of the research team
- Presence of a robust statistical analysis plan
- Publication plan
- No potential conflicts of interest exist. If conflicts of interest are present, there is a plan to address them.
Prior to data being released, the researcher(s) will be expected to sign a Data Sharing Agreement, which requires the researcher(s) to obtain any necessary ethics board or regulatory approval for conduct of the research.
Upon execution of an agreement, the de-identified and anonymized data sets may be accessed within a secured portal which provides an environment for statistical programming with “R” as the programming language. This programming language enables the ability to write and execute program(s) with various “R” packages available under free license of “R”. ?The packages available include: statistics, graphics, grDevices, utils, datasets, methods and base.
Bristol-Myers Squibb and the Duke Clinical Research Institute have also collaborated on a new initiative to promote open access to clinical information from our trials through the data sharing model of Supporting Open Access for Researchers (SOAR). The DCRI-BMS Data Sharing Initiative website provides information on the status of all requests submitted. In addition, external researchers will be given access to ask scientific questions using the Duke Cardiovascular Databank. By opening up access to this clinical data, SOAR hopes to stimulate both novel research as well as encourage other academic researchers to share their data.
Read our Disclosure Commitment.