Conduits provides access to a wide variety of unique institutional resources that help investigators achieve their research aims. Available resources include technical expertise, sophisticated equipment, and staff to collaborate in the design, development, and execution of research protocols.
The Biorepository Cooperative provides basic histology services, with capability to process, embed, and section fixed and frozen tissues for the Mount Sinai community. The facility will prepare unstained slides suitable for a variety of applications (histochemistry, immunohistochemistry, in situ hybridization, Laser Capture Microdisection LCM), as well as hematoxylin and eosin sections for routine light microscopic evaluation.
Biostatistics, Epidemiology, and Research Design (BERD) Program
The BERD Program offers an integrated resource for clinical and translational investigators at Icahn School of Medicine in study design, biostatistics, and bioethics. In particular, it provides:
- Consultative services and long-term collaborative support in study design and biostatistics, from the planning stages through data analysis and interpretation
- Epidemiology Consult Services that offer assistance on the epidemiologic aspects of study design and conduct.
- Statistical Advisory Services that offer assistance on study design, sample size and power calculation, data analysis of small projects, assistance with grant submission, manuscript and abstract preparation, database design and data management.
- Education and training in study design, biostatistics, and bioethics applicable to clinical and translational research
- Expertise to incorporate bioethical considerations into the design, conduct, and interpretation of studies, and to develop innovative approaches to the study of bioethical issues in clinical and translational research
The Statistical Advisory Service offers overall consultation in statistical design and analysis of clinical and translational studies, including genetic epidemiology. Specific expertise in statistical designs for novel clinical trials and comparative effectiveness research designs is provided by the International Center for Health Outcomes and Innovation Research (InCHOIR). The Translational Research Ethics Committee provides a multidisciplinary forum for the discussion of bioethical issues available to Mount Sinai investigators.
Clinical Trials and Comparative Effectiveness Research
The International Center for Health Outcomes and Innovation Research (InCHOIR) within the Department of Population Health Science and Policy, in collaboration with the Office of Clinical Research and Research Information Technology, offers expertise in the design, conduct, and analysis of randomized trials of novel interventions, ranging from proof-of-concept (Phase I and II) to large-scale multicenter clinical trials and comparative effectiveness research.
This group provides consultation, support, and services in the following areas:
- Design of comparative effectiveness trials and randomized trials of novel interventions, including selection and measurement of endpoints (e.g., functional status, quality of life, economic endpoints), choice of comparison arms, standardization of interventions, definition of the appropriate patient population, and refinement of recruitment strategies
- Statistical design and analysis of trials employing optimal multistage designs in Phase I and II studies, sample size calculations, adaptive trial designs, and implementation of novel Bayesian approaches
- Creation of study documentation, including protocols, case report forms, and manuals of operations/procedures
- Informatics, including study websites and the design of secure, centralized, electronic data capture (EDC) systems that are HIPAA- and FDA-compliant, that accommodate a broad range of work flows dictated by study design
- Selection and management of core labs, medical monitors, and oversight committees such as Data Safety Monitoring Boards DSMBs and event adjudication committees
- Regulatory affairs, including IND and IDE submissions, Food and Drug Administration (FDA) reporting, and Pre-Market Approval (PMA)development
- Data integrity and quality assurance, including remote (electronic) and on-site source documentation auditing
Statistical Advisory Service
James Godbold, PhD
Translational Research Ethics Committee
Rosamond Rhodes, PhD
Clinical Trials and Comparative Effectiveness Research
Department of Population Health Science and Policy
Center for Biomedical Informatics
The CBI's programs are designed to facilitate the movement of promising wet bench research and theoretical modeling into clinical testing, and more rapidly translating research discoveries into clinical practice. These interventions will lead to patient-oriented outcomes research that will generate new basic science research questions that can be taken back to the bench.
The Mount Sinai Health System (MSMC) has committed itself to building a substantial biomedical informatics infrastructure. The CBI will direct the design and implementation of this campus-wide research resource. Conduits will leverage MSMC's investments in biomedical informatics resources to support clinical and translational research.
MSMC, and its affiliated health organizations and community resources, will greatly benefit from the provision of interoperable, institution-wide accessibility of Conduits data sets for PPHS -approved studies. Benefits will be realized both by Conduits and by the Clinical Translational Science Award Informatics Consortium, which will be able to share in the tools and resources created by the CBI under the very backing of Conduits.
Our data collection and storage methods will emphasize data interoperability and the development of an expert rules engine to facilitate smart access to the interoperable model-based research data repository. The interoperable data repository will be augmented by the development of best-of-breed analytics that will create and share clinically useful mathematical and statistical models across Conduits.
Translational Research Genomic Data Analysis Pipeline and Toolset
Mount Sinai is also making available genome browser tools provided by the University of California - Santa Cruz. These tools are used to provide effective sequence display of requested portions of genomes along with annotation tracks. More detailed description of the tools can be found at the UCSC genome website.
Clinical Research Center (CRC)
The CRC provides the necessary infrastructure to effectively and safely perform clinical-translational research studies. Resources include inpatient and outpatient space, nursing, bionutrition, specimen processing, and information technology support.
Experimental Therapeutics Institute (ETI)
The ETI serves as the interdisciplinary institutional platform for the development of new drugs, devices, and intellectual property that grow out of Mount Sinai's basic and clinical research projects.
Charles R. Bronfman Institute for Personalized Medicine (IPM)
The IPM explores how genetic information and environmental exposure affect each person's risk to develop certain diseases and response to medication. IPM provides an innovative, integrated genomic and translational research hub for groundbreaking research to redefine complex diseases on a molecular level. Our programs enable Mount Sinai researchers to define genetic risk, molecular pathogenesis, and molecular diagnosis of common, complex diseases in unique and well-characterized patient populations that are accessible for studies through a rich fabric of outstanding disease research centers at Mount Sinai.
The Translational and Molecular Imaging Institute is advancing the science of imaging, from the development of new visualization technology to improved contrast agents. The Institute is applying imaging modalities in both preclinical basic science and clinical research settings to improve diagnostic accuracy, increase the understanding of pathophysiology and metabolism, and measure therapeutic efficacy.
Investigational Drug Service (IDS) - The Department of Pharmacy maintains an Investigational Drug Service (IDS) to support research activities at Icahn School of Medicine. The IDS is a research pharmacy charged with maintaining the control and accountability of investigational agents (FDA approved and non-approved) in compliance with Good Clinical Practices (GCPs), Good Manufacturing Practices (GMPs) and other regulations and laws as appropriate. The IDS provides dedicated research support including protocol review, storage, preparation, dispensing and education to groups and investigators engaged in research.
Shared Resource Facilities (SRFs)
Shared Resource Facilities (SRFs) bring state-of-the-art instrumentation, methodologies, and opportunities for collaboration crucial to modern biomedical research cores within the reach of all Mount Sinai investigators and graduate students. The facilities are staffed by experts who provide research services, act as sources of instruction and training, and, therefore, constitute a major educational resource for those wishing to diversify or explore new avenues of research.
Sonia Kleiner-Arje, MSRA, CHRC
Director, ISMMS ConduITS CTSA, Institutes for Translational Sciences
Director, Office of Research Services (ORS)
ConduITS is supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences of the National Institutes of Health through Grant Number UL1TR001433.
Any use of CTSA-supported resources requires citation of grant #UL1TR001433 awarded to Icahn School of Medicine in the acknowledgment section of every publication resulting from this support. Adherence to the NIH Public Access Policy is also required.