International Center for Health Outcomes and Innovation Research (InCHOIR)
Rapid advances in biomedical research have drawn attention to the critical need for an effective clinical trials system that can generate the evidence needed to translate discoveries into improved patient care, and illuminate targets for further innovation. InCHOIR is an academic clinical research center, whose mission is the design, conduct, and analysis of multi-center trials and observational studies.
The Center's interdisciplinary faculty and staff have expertise in biostatistics, health economics, quality of life assessment, clinical coordination, drug and device regulation, clinical and data monitoring, informatics, and health policy analysis. The Center has built the infrastructure for designing and conducting multi-center clinical trials and observational studies. A key area of interest and expertise of InCHOIR is development of novel and innovative designs for clinical trials. In collaboration with the Mount Sinai Center for Biostatistics, InCHOIR has responded to challenges in the design, conduct, and analysis of complex clinical trials in a variety of clinical areas. Design innovations include employing staged adaptive approaches, application of fully sequential and Bayesian approaches, and combining randomized and non-randomized data using both classical and Bayesian approaches, and randomization at the point of care. The Center's diverse analytical expertise includes hierarchical modeling, survival analysis, development and validation of risk scores, analysis of imaging data and biomarkers, cost effectiveness analysis, longitudinal methods, and quality of life analysis.
Trial management expertise includes:
- Clinical site management, which includes site selection, site training and initiation, and monitoring. InCHOIR employs innovative clinical trial conduct methods, including risk based and remote EMR access data monitoring, centralized data collection, and leveraging clinical data in clinical trials.
- Recruitment and Retention - InCHOIR has a strong track record in ensuring successful patient recruitment and retention for trials including investigational devices, drugs, biologics and procedures, as well as for comparative effectiveness trials.
- The data management group provides regular reports on data completeness and quality.
- EAC and DSMB - A robust infrastructure exists for management of independent endpoint and event adjudication, as well as DSMB coordination.
- Interactions with Regulatory Agencies and Payer Community - InCHOIR has experience running national and international trials, and expertise in interacting with FDA, European regulatory agencies, and payers, as well as ensuring human subject protection.
- Remote Electronic Data Capture - An early innovator in this area in the 1990's the Center has developed proprietary electronic data capture software with features and functionality that facilitate large scale international trials. In addition to compliance with federal regulations (FISMA, FDA) the system provides specimen tracking, clinical imaging and source document management, task management, and committee management (DSMB, Adjudication), among other features.
InCHOIR has an extensive library of administrative and clinical datasets and experience in analyzing claims and survey data that include Medicare, Medicaid, University Hospital Consortium, State-wide discharge databases, NIS and NHDS. These databases offer a mechanism to (1) provide a real-time look at the change in utilization rates of clinical interventions and geographical variations in their use, which can be used to generate new hypotheses; (2) provide supplementary claims data for economic analysis in clinical trials; (3) extrapolate the potential impact of clinical trials findings to the national level and (4) undertake comparative effectiveness evaluations. The large dataset analysis unit is directed by Natalia Egorova, PhD.
InCHOIR was the Coordinating Center for the NHLBI-sponsored REMATCH trial which established the value of left ventricular assist devices (LVADs) as long-term treatment for advanced heart failure. InCHOIR successfully competed to become the Data and Statistical Coordinating Center for the NHLBI-funded Specialized Clinical Center of Research (SCCOR) grant. It has served as the data and clinical coordinating center for the NHLBI-supported Cardiothoracic Surgical Trials Network since 2006. It is also the coordinating center for the NINDS-supported randomized trial comparing conservative management to prophylactic eradication of unbled brain arterio-venous malformations in Europe, Australia, North and South America, and Asia. InCHOIR also supports trials in Traumatic Brain Injury (TBI) and is the DCC for a variety of RCTs and longitudinal studies in patients with TBI. InCHOIR recently completed a multicenter prospective cohort study funded by an NHLBI ARRA grant to evaluate the outcomes and practice patterns of Hybrid Coronary Revascularization, an emerging treatment paradigm to treat coronary artery disease with combined surgical and percutaneous approaches. The Center was recently funded to be the coordinating center for an NHLBI funded Cardiac Translational Implementation Project (CTRIP) grant evaluating a novel targeted gene therapy for the treatment of heart failure. Other areas of research include the cost-effectiveness of screening for aortic aneurysms and peripheral vascular disease and disparities in the treatment of vascular conditions.
Mary Ann Kral, PA-C, MS
- Trial and Study Design
- Clinical Coordination
- Clinical Epidemiology
- Health Economics
- Decision Analysis
- Quality of Life
- Clinical Trial Operations
- Patient recruitment and retention
- EAC and DSMB Management
- International Multi-center Trials and Research Networks
- FDA-compliant electronic data capture systems
- Health Policy Analysis