DCRI-BMS Data Sharing Initiative
The DCRI has partnered with Bristol-Myers Squibb (BMS) to expand access to clinical trial information from BMS-sponsored studies. Clinical trial information being made available for scientific research through SOAR™ includes protocols, full clinical study reports and de-identified patient-level data and study-level data for medicines and indications approved in the United States and/or Europe. Information from terminated programs will be available two years after discontinuation.
Each proposal is quickly reviewed by an Independent Review Committee with expertise in biostatistics, research ethics, patient privacy, and the clinical specialty of the research to evaluate the statistical analysis plan, plan to protect patient privacy, dissemination plan and qualification of the investigator(s). The data and analytical tools are provisioned directly to the investigator. The committee also reviews the final manuscript prior to submission to assess concordance with the stated analysis plan.
Under Review: The request/proposal is currently being reviewed internally by a qualified panel of Bristol-Myers Squibb experts. If the proposal is considered within scope, the request will undergo an additional review by the independent review committee (DCRI).
Declined/Out of Scope: the request does not meet the current requirements of the BMS Data Sharing Policy.
Approved: Passed BMS evaluation criteria and the criteria of the Independent Review Committee (DCRI).
Data Shared: Investigator has received access to the requested data, via a secure CTDT portal.
Published: Public disclosure of the research results, e.g. publication in a scientific journal, poster at a scientific conference, etc.
Manuscript Submitted: Research is complete, and the resulting manuscript has been reviewed by BMS and submitted for publication to a scientific journal.
Withdrawn/Lost to Follow-Up: Researcher either has withdrawn the research proposal, at any stage, or there is no reply regarding follow-up clarifications.
Overall Summary of Requests (Table 1)
|Data Sharing Requests since 2013||Total|
|Date Requests Received||184|
|Declined/Out of Scope||125|
|Approved - Pending Signed DSA||5|
|Withdrawn / Lost to Follow-Up||10|
* Also includes 1. requests for summary data and 2. requests for genomics data shared on a public website.
Out of Scope Requests (Table 2)
|Reasons for Out of Scope||Total|
|< 2 years post database lock||74|
|Note a Data Sharing Request***||12|
|Not BMS Asset or Study||8|
|Study Not in an Approved or Marketed Product||4|
|Study Completed Before 2008||3|
|Study Did Not Pass Informed Consent Check||11|
|Final Study Completion Date Not Reached||5|
** for declined research proposals with more than one reason for a decline, e.g. where more than one study was requested in a single research proposal, only one reason for a decline is documented in these metrics.
***Not a request for secondary analysis by a third-party/independent researcher