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 for trials completed after January 2008. 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

DCRI-BMS metrics 06292017
Status of Requests (2013-17)
 Total
Data Requests Received 47
In Review 7
Out of Scope 20
Approved 18
Request Fulfilled 12
Publications 1

 

Reasons for Out of Scope  Total
Clinical or Noninterventional  ISR Request 0
Duplicate Submission 3
Investigational Product 0
Not a BMS-owned Asset 1
Not a BMS-sponsored Study 1
Program Not Approved for Marketing 4
Study Completed Before 2008 2
Study Ongoing 7
Withdrawn by Requester 2
TOTAL 20

 

Approved Requests

Proposal ID Requester Proposal Name Affiliation
2014-04 Maruff, Paul Understanding the Nature and Magnitude of Cognitive Impairment in People with Major Depressive Disorder University of Melbourne, Australia
2014-10 Damman, Kevin Changes in Renal Function with Neprilysin Inhibition versus Angiotensin Converting Enzyme Inhibition in Patients with Heart Failure University of Glasgow, Glasgow, UK
2015-11 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, Alabama, USA
2015-12 Conry, Robert Impact of Concomitant Statin Use on Efficacy and Toxicity of Ipilimumab University of Alabama - Birmingham, Alabama, USA
2015-17 Mistry, Hitesh Survival  Modelling  of  Yervoy in  Melanoma University of Manchester, Manchester, UK
2015-19 Quach, Caroleen Joint Analysis of Health-Related Quality of Life Trajectories and Survival and Tumor Response Endpoints University of North Carolina - Chapel Hill, North Carolina, USA
2016-21 Baigent, Colin Cholesterol Treatment Trialists' (CTT) Collaboration: Analyses of Adverse Event Data from Randomized Controlled Trials of Statin Therapy University of Oxford, Oxford, UK
2016-22 Pinato, David An  Objective  Biomarker  to Optimize  Treatment  Decisions  in Advanced  Hepatocellular Carcinoma  after  Sorafenib Failure Imperial College London, London , UK
2016-23 Ferrucci, Francesco Baseline  Neutrophil-Tolymphocyte  Ratio  and  Benefit from  Ipilimumab European Institute of Oncology, Milan, Italy
2016-24 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, USA
2016-25 McQuade, Jennifer Association of Obesity with Clinical Outcomes in Metastatic Melanoma Patients Treated with Immunotherapy MD Anderson Cancer Center, USA
2016-28 Sorich, Michael Early Markers of Clinical Outcome to Ipilimumab Therapy for Advanced Melanoma Flinders University, Adelaide, Australia
2016-29 Neuman, Gal Unintentional Ingestion of Apixaban in a Toddler Ruth and Bruce Rappaport Faculty of Medicine, Haifa, Israel
2016-32 Williamson, Lee Anne Evaluating the Placebo Endoscopic Response in Crohn’s Disease Clinical Trials Robarts Clinical Trials, London, Canada
2016-24 Hou, Jinlin A 5- Year Follow-up Study of Subjects Who Completed the REALM- China Study Nanfang Hospital, Southern Medical University, Guangzhou, China
2017-36 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, Washington, USA
2017-64 D’Agostino, Maria Antonietta Rasch Analysis of APPRAISE Power Doppler Ultrasound Data APHP, Hôpital Ambroise Paré, Boulogne-Billancourt, France