DCRI-BMS Data Sharing Initiative

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.

Data Governance

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.

Summary Reports

Data Requests Received  57
In Review 21
Out of Scope 30
Approved 22
Request Fulfilled 10
Publications 1
Out of Scope Reasons  Total
ISR Request 7
Duplicate Submission 4
Investigational Product 1
Not a BMS owned Asset 1
Non-BMS Sponsored 1
Not Approved for Marketing 3
Less than 2 Years Database Lock 9
Withdrawn by Requestor 3
Study Completed Before 2008 1
Total 30

Approved Requests

Date Approved Requester Proposal Name Affiliation
08/29/2014 Maruff, Paul Understanding the Nature and Magnitude of Cognitive Impairment in People with Major Depressive Disorder University of Melbourne
Melbourne, Australia
06/03/2015 Damman, Kevin Changes in Renal Function with Neprilysin Inhibition versus Angiotensin Converting Enzyme Inhibition in Patients with Heart Failure University of Glasgow
Glasgow, UK
03/23/2015 Sonpavde, Guru Individual Patient Analysis of Control Arms of Randomized Trials to Assess Impact of Single Agent Daily Prednisone on Outcomes and Toxicities in Metastatic Castration-Resistant Prostate Cancer University of Alabama
Comprehensive Cancer Center
Birmingham, Alabama
10/22/2015 Conry, Robert Impact of Concomitant Statin Use on Efficacy and Toxicity of Ipilimumab University of Alabama - Birmingham
Birmingham, Alabama
07/05/2016 Mistry, Hitesh Survival  Modelling  of  Yervoy in  Melanoma University of Manchester
Manchester, UK
12/15/2015 Quach, Caroleen Joint Analysis of Health-Related Quality of Life Trajectories and Survival and Tumor Response Endpoints University of North Carolina at Chapel Hill
Chapel Hill, North Carolina
12/04/2015 Baigent, Colin Cholesterol Treatment Trialists' (CTT) Collaboration: Analyses of Adverse Event Data from Randomized Controlled Trials of Statin Therapy University of Oxford
Oxford, UK
08/31/2016 Pinato, David An  Objective  Biomarker  to Optimize  Treatment  Decisions  in Advanced  Hepatocellular Carcinoma  after  Sorafenib Failure Imperial College London
London , UK
07/128/2016 Ferrucci, Francesco Baseline  Neutrophil-Tolymphocyte  Ratio  and  Benefit from  Ipilimumab European Institute of Oncology
Milan, Italy
07/15/2016 Halabi, Susan Combined Analysis of Age and Race Predicting Clinical Outcomes in Men with Metastatic Castrate- Resistant Prostate Cancer (mCRPC) Duke University
Durham, North Carolina
09/30/2016 McQuade, Jennifer Association of Obesity with Clinical Outcomes in Metastatic Melanoma Patients Treated with Immunotherapy MD Anderson Cancer Center
Houston, Texas
03/15/2017 Sorich, Michael Early Markers of Clinical Outcome to Ipilimumab Therapy for Advanced Melanoma Flinders University
Adelaide, Australia
03/24/2017 Neuman, Gal Unintentional Ingestion of Apixaban in a Toddler Ruth and Bruce Rappaport Faculty of Medicine
Haifa, Israel
04/26/2017 Williamson, Lee Anne Evaluating the Placebo Endoscopic Response in Crohn’s Disease Clinical Trials Robarts Clinical Trials
London, Canada
10/21/2016 Hou, Jinlin A 5- Year Follow-up Study of Subjects Who Completed the REALM- China Study Nanfang Hospital, Southern Medical University
Guangzhou, China
04/25/2017 Ringold, Sarah Identifying Trajectories of Disease Activity States in Juvenile Idiopathic Arthritis (JIA) Early After Treatment: Shortening Time to Decision to Change Treatment Seattle Children’s Division of Rheumatology
Seattle, Washington
06/07/2017 D’Agostino, Maria Antonietta Rasch Analysis of APPRAISE Power Doppler Ultrasound Data APHP, Hôpital Ambroise Paré
Boulogne-Billancourt, France
07/28/2017 Vaduganathan, Muthiah Extended-Duration Thromboprophylaxis with Direct-Acting Oral Anticoagulants After Hospitalization for Heart Failure: A Meta-Analysis Brigham and Women’s Hospital
Boston, Massachusetts
10/23/2017 Leahy, Joy Incorporating individual patient data into a network meta analysis: statistical methods project Trinity College Dublin
Dublin, Ireland