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.
In 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).
Out of Scope: the request does not meet the current requirements of the BMS Data Sharing Policy.
Approved: Successful review by BMS stakeholders and an Independent Review Committee (DCRI) with a fully-executed data sharing agreement.
Request Fulfilled: Investigator has received requested data via a secured CTDT portal.
Publications: Disclosure of the research results which include manuscripts, abstracts, and the summary of results.
Overall Summary of Requests (Table 1)
|Data Sharing Requests since 2013||Total|
|Date Requests Received||165|
|Out of Scope||116|
|Resulting in Publication||3|
|Approved (in process)||11|
|Withdrawn by requestor||8|
* Requests Fulfilled also include 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||78|
|Not BMS Asset or Study||16|
|Program not approve for marketing||3|
|Study Completed Before 2008||3|
|Did not pass Informed Consent Check||3|
|Final study completion date not reached||5|