A key tenet of the DCRI’s mission is to share knowledge. One way in which we can achieve this goal is by sharing with other researchers data from our collaborations, clinical trials, and appropriate or relevant observational studies.
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.
The Duke Databank for Cardiovascular Disease (DDCD) is a clinical care database, established in the 1960s by a research team within the Duke Division of Cardiology. As a component of the DDCD, data were collected on patients undergoing cardiac catheterization for suspected coronary artery or valvular heart disease, and on patients undergoing cardiac surgery. These data were used to generate reports for the patients’ medical records, but were also made available for clinical research, for example, research studies to improve the medical care of patients with coronary artery disease. The Duke-owned DDCD is one of the largest and oldest cardiovascular databanks in the world. Duke researchers have conducted several cardiology outcome studies using this source data.
At the DCRI we believe that the dissemination of clinical research results is vital and that the sharing of data is important. In accordance with the International Committee of Medical Journal Editors’ (ICMJE) data sharing recommendation, we encourage researchers interested in accessing clinical trial data from primary results articles published after July 1, 2018 to submit a research proposal and publication plan.
SOAR™ (Supporting Open Access for Researchers) is a collaboration between the Duke Clinical Research Institute (DCRI), academia, and private industry to open clinical research data for the benefit of the broader research community.
The goal of SOAR™ is to foster transparency and openness in research, enabling researchers to more rapidly build upon previous work and allowing patients to gain access to needed therapies more quickly. The SOAR™ committee includes experts in biostatistics, research ethics, patient privacy, and the clinical specialty of the research. Proposals will be evaluated based on their scientific rationale as well as their analysis plans.
Brian J. McCourtDirector, Data Solutions
"We promote data sharing by allowing investigators to verify trial results as well as to pursue interesting secondary uses of trial data without compromising scientific integrity."
SOAR™ aims to facilitate open sharing of clinical trial data with responsible researchers to promote open science and allow investigators to verify trial results as well as pursue interesting secondary uses of trial data. Ultimately, this increase in transparency will inform science and improve patient care.
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.
The SOAR™ program enables responsible data sharing through partnerships among academia, industry, and individual investigators. Overseen by senior experts from clinical science, biostatistics, and regulatory practice, SOAR™ is at the forefront in understanding the complexities of data sharing and secondary analysis.