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

DataSharing Requests 2013_2019_012020

Status Definitions

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Withdrawn/Lost to Follow-Up: Researcher either has withdrawn the research proposal, at any stage, or there is no reply regarding follow-up clarifications.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
Under Review 14
Declined/Out of Scope 125
Approved - Pending Signed DSA 5
Data Shared* 24
Withdrawn / Lost to Follow-Up 10
Published 3
Manuscript Submitted 3

* 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
Duplicate Submission 8
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

Approved Requests with Signed Data Sharing Agreements (Table 3)

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
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
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
10/22/2015 Conry, Robert Impact of Concomitant Statin Use on Efficacy and Toxicity of Ipilimumab University of Alabama - Birmingham
Birmingham, Alabama
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
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
07/05/2016 Mistry, Hitesh Survival  Modelling  of  Yervoy in  Melanoma University of Manchester
Manchester, UK
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
07/28/2016 Ferrucci, Francesco Baseline  Neutrophil-Tolymphocyte  Ratio  and  Benefit from  Ipilimumab European Institute of Oncology
Milan, Italy
08/31/2016 Pinato, David An  Objective  Biomarker  to Optimize  Treatment  Decisions  in Advanced  Hepatocellular Carcinoma  after  Sorafenib Failure Imperial College London
London , UK
09/30/2016 McQuade, Jennifer Association of Obesity with Clinical Outcomes in Metastatic Melanoma Patients Treated with Immunotherapy MD Anderson Cancer Center
Houston, Texas
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
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
04/25/2017 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
04/26/2017 Williamson, Lee Anne Evaluating the Placebo Endoscopic Response in Crohn’s Disease Clinical Trials Robarts Clinical Trials
London, Canada
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
10/27/2017 Hodi, Stephen Correlation of medications and medical comorbidities with clinical response and toxicity during treatment with ipilimumab Dana-Farber Cancer Institute, Boston Massachusetts
12/01/2017 Teague, Ryan Understanding how obesity influences immunotherapy in melanoma patients Siteman Cancer Center, St. Louis, Missouri
01/11/2018 Rabbie, Roy Cutaneous Toxicities Associated with Immune Checkpoint Inhibitors in Advanced Melanoma: A Systematic Review and New Proposed Management Algorithm Cambridge University Hospitals NHS Foundation Trust,  Cambridge, Cambridgeshire CB2 0QQ, United Kingdom
01/17/2018 England, Bryant Correlation of the MBDA score with composite RA disease activity measures in the AMPLE study University of Nebraska Medical Center, Omaha, Nebraska
02/28/2018 Edeline, Julien Patient Reported Outcome (PRO) As A Prognostic Marker In Patients Treated With Targeted Therapies For Advanced Hepatocellular Carcinoma (PRO²-HCC) Av bataille Flandres-Dunkerque, Rennes, France
04/17/2018 Beyhaghi, Hadi Evidence-Based Prescribing of Ipilimumab vs. Dacarbazine for Advanced Melanoma: Using Advanced Predictive Analytics to Integrate Treatment Effectiveness and Patient Values The University of North Carolina at Chapel Hill, Carrboro, North Carolina
04/24/2018 Ogdie-Beatty, Alexis Construct Validity and Responsiveness of Instruments Used in Psoriatic Arthritis Clinical Trials University of Pennsylvania, Philadelphia, Pennsylvania
07/02/2018 Derolez, Sophie Influence of demographic and environmental factors on anti-TNF efficacy in rheumatoid arthritis: a systematic review and meta-analysis of randomized controlled trials - PROSPERO number CRD42018071079 University Hospital of Tours, France
07/11/2018 Desai, Nihar Falling for Direct Oral Anticoagulants in the Elderly: Can Improved Safety Profiles Overcome Anticoagulation Underutilization in Older Adults with Atrial Fibrillation at High Risk for Falls? Yale New Haven Hospital
New Haven, Connecticut
11/13/2018 Navar, Ann Marie Using the Statin Trials Pooled Dataset to Develop a Model of Cardiovascular Risk Recurrence Duke University,
Durham, North Carolina
5/30/2019 Haanen, John

Study to investigate the predictive value of serum LDH for immunotherapy related toxicity in patients with advanced melanoma

Netherlands Cancer Institute