Participant Recruitment and Retention: The goal of this effort is to improve participant recruitment & retention rates within and beyond the NYULMC Community by promoting efforts to embed research into routine practice at NYULMC, providing tools to assist researchers in recruiting and retaining participants, developing IT solutions, and making training in recruitment and retention for junior faculty involved in clinical research. The NYU-HHC CTSI has also adopted the ResearchMatch program, developed by the CTSA Consortium, a secure registry for bringing together people who are trying to find research studies and researchers who are looking for people to participate in their studies.
Multisite Clinical Research: This unit specifically addresses any barriers clinical researchers may have when developing large multicenter clinical trials and registries by providing experienced faculty and staff to assist with proposal development, coordination, and administration during pre-award phases of a study.
Biomedical Informatics: The Biomedical Informatics Program (BMIP), based in the Center for Health Informatics and Bioinformatics (CHIBI) and developed at NYU to a large extent to support the mission of the CTSI, serves as the CTSI’s informatics core. BMIP provides next generation DNA sequencing and microarray informatics and an in-house High Performance Computing Facility with 1PB of scalable storage and 1000 compute nodes as well as access to a range of leadership class machines and commercial cloud solutions. BMIP also supports the creation of new software and methods to support translational research. The Best Practices Integrated Informatics Consulting and Collaborative Science core (BPIC) provides in-depth project consultations and supports grant applications.
Biostatistics and Study Design: The CTSI Biostatistics and Study Design unit provides statistical consulting and collaboration through one-on-one sessions as well as in-depth grant and protocol development. Departmental collaborations have also been implemented in high-use departments to facilitate access to statistical resources. Teaching and training in statistics are provided through online courses and integrated throughout relevant CTSI curriculum.
Health and Hospitals Corporation: The CTSI’s clinical partner, HHC, provides access to a variety of patient, provider, health care facility and geographic communities. This partnership allows researchers to address health disparities in racial/ethnic minority and other underserved populations; test and evaluate evidence-based interventions in real-world settings using the pragmatic trials model; study rare diseases with larger patient population groups; and increase the generalizability of clinical research. The HHC-CTSI collaboration provides funding to support collaborative pilot projects in clinical and translational research, education and training for HHC researchers, works to enhance the research infrastructure at HHC, and reduces regulatory barriers to NYU/HHC collaborative research studies. In addition, the HHC Data Services Center provides NYU and HHC researchers access to the unparalleled richness of HHC’s clinical data.
Translational Research Core: The Translational Research Core functions as a disease-agnostic steward of the collective expertise, tools and know-how that exist across the University, a hub for the identification of areas of common interest within members of the research community, and a facilitator for the genesis, sprouting and growth of inter-disciplinary, multiple-investigator translational research. In service to this mission, the core provides Research Studios, in-depth sessions in which researchers obtain expert advice and feedback (across disciplines, translational phases, and methodological areas) on their protocol, grant application and/or manuscript. The broader goal is to improve the feasibility, quality, and potential impact of clinical and translational research projects. Support is also available for drug and device development as part of a new Virtual Accelerator Program designed to stimulate and facilitate new therapeutics projects.
Clinical and Translational Research Funding and Support: Direct funding for research and/or access to essential research services provided through the CTSI are available, by application and scientific review, through several mechanisms/programs, including:
Resource Allocation Program (RAP): Provides different levels of support or services for investigators in the form of CTSI services and resources, e.g., Clinical Research, biostatistics, bioinformatics, population health and other relevant services.
Targeted Resource Allocation Program (TRAP): Provides funding for targeted research needs not available as part of the CTSI’s menu of services and resources.
Pilot Project Program (PPP): Provides direct funding to support collaborative scientific studies to enable development of preliminary data to serve as a foundation for submission of translational research grant applications.
Child Health Translational Research Program: The CTSI is supporting the concentration of expertise in translational research in child health by bringing together pediatric researchers, including the creation of a Pediatric Research Strategy Group in which Senior Pediatric Investigators meet, on a monthly basis, with each Division to assess ongoing research, provide mentoring and involve young investigators in CTSI programs.
Consultation Services: Brief consultation is available through the CTSI’s network of expertise in biomedical informatics, biostatistics and research design, clinical research ethics, community engagement principles and approaches, population health research methods, and drug development. In-depth “workshop” sessions are available to review, critique and enhance research grant applications and manuscript submissions (Research Studios).
Community Engagement and Population Health Research: The Community Engagement and Population Health Research Program (CEPHR) serves as a cornerstone of the CTSI’s efforts to establish an integrated home for community-engaged translational research and foster the conduct of T3/T4 translational research among NYU and its institutional and community partners. CEPHR’s mission is to promote collaboration between community members, researchers, health and social service providers, community-based organizations, academic investigators, and policymakers that advances research to identify and disseminate relevant and effective strategies to make people and populations healthier and to reduce and eliminate health inequities. To achieve this mission, CEPHR provides consultation and training and education in Comparative Effectiveness, Patient-Centered Outcomes, and Community-Based Participatory research design and methods. In addition, CEPHR supports T3/T4 grant applications through pilot funding, facilitating data requests, consultations, fostering linkages and making introductions, providing letters of supports, and targeted seminars and trainings (e.g., Community-Based Participatory Research methods for researchers).
Training and Education in Translational Research: The Translational Research Education and Careers (TREC) program offers a variety of degree and training programs and collaborates regularly with the other units to offer additional education and training. The following degree programs and training opportunities are available:
The Empire Clinical Research Investigator Program (ECRIP): A New York State Department of Health program intended to encourage clinical research and clinical research training at New York State Hospitals that support graduate medical education.
School of Medicine Fellowship in Primary Care Research: An interdisciplinary, two-year, HRSA-funded National Research Service Award (T32) fellowship program designed to prepare physicians for careers in primary care research.
KL2 Program in Translational Research: A University-wide post-doctoral training and career development opportunity for physicians, nurses, dentists, and other appropriate health professionals.
TL1 PhD Program in Clinical and Translational Research: A University-wide doctoral training opportunity for PhD students. The program focuses on the support and development of doctoral candidates seeking careers in translational research.
Physician Scientist Training Program (PSTP): Established to support and encourage the participation of physician-trainees in intensive experiences in translational research.
Mentor Development Program (MDP): The CTSI aims to ensure success of translational research at NYU by developing a cadre of research and career mentors through the Mentor Development Program.
Online Training Courses:
Introduction to Clinical Research
Introduction to Biostatistics
Masters of Science in Clinical Investigation for Board-Eligible Clinicians (Translational Research Track): This training program consists of a core curriculum and mentored research experiences for clinician-scientists interested in applying scientific discoveries to the clinical setting.
MD/MS in Clinical Investigation: The dual MD/MSCI is designed for students interested in translational research who wish to develop skills needed to succeed in their future careers.
Certificate in Translational Research: Intended to help individuals obtain the foundation, skills and knowledge essential for a career in translational research.
Summer Intensive Program in Translational Research Methodologies: Provides a cohesive foundation in clinical research methods, biostatistics, medical bioinformatics, and ethics and is designed for participants with limited formal didactic training in research methodologies who wish to rapidly develop skills for more advanced study and for participation in new or ongoing research projects.
Comparative Effectiveness Research:
Masters of Science in Clinical Investigation for Board Eligible Clinicians (Comparative Effectiveness Track). The goal of this program is to increase the nation’s supply of physician-investigators conducting Comparative Effectiveness Research centered around health decisions affecting urban under-served communities.
Certification in Comparative Effectiveness Research. The Comparative Effectiveness Research Certification Program provides education and career development in comparative effectiveness research training through mentorship and coursework.
Clinical Investigator & Development Education Resources (CIDER): Provides a cross-institutional training resource for investigators and research coordinators who are relatively new to clinical research, focusing on operational day-to-day responsibilities to ensure subject protection/compliance.
Collaboration: The CTSI fosters collaboration in many different ways; principal approaches include:
Science Interest Groups – Serve as "nucleation" point for sharing of ideas and resources
Ion Channels and Transporters Interest Group
Bones Interest Group
TR in Inflammation & Atherosclerotic Disease Interest Group
Crystal Diseases Study Group
Primary Immunodeficiency Science Interest Group
Team Science Working Group – Central resource for the development of team science and the study of team science
Translational Science Librarian – Facilitates collaborations and supports technology to promote collaboration including Find-A-Researcher and other research networking tools, Faculty Bibliography, and eagle-i, a resource discovery tool for synergizing resources and expertise across individual research teams/labs.
Seminars and Events that Bring Researchers Together – Including Translational Research in Progress Seminars (TRIP) and Networking events (e.g., Seminar/Poster Day - "Bioengineering at NYU Polytechnic School of Engineering: Opportunities for Collaborative Translational Research").
The Cardiovascular Clinical Research Center (CCRC) provides an infrastructure for clinical research in the NYUSOM Division of Cardiology. Located in a 2,500 square foot space, there are 10 offices and a large conference room for meetings. The unit and all the offices are double-locked to comply with privacy obligations related to storage of study materials. There is excellent IT support through the NYU School of Medicine which includes backup and storage of project data on a Storage Area Network offsite server. There is full access to almost all electronic collections such as Ovid, PubMed, Psychlit, and online journals through the T-1 connection to the NYUSOM and the main NYU Washington Square library systems that are supported by award winning reference services. There is an abundance of classroom space equipped with computer and projection for meetings and educational sessions. The CCRC has a contract with eVelos to provide compliant, encrypted internet based data management services.
Division of Alcoholism and Drug Abuse, Department of Psychiatry
NYUSOM and Bellevue Hospital Division of Alcoholism and Drug Abuse comprise one of the nation’s largest divisions of substance abuse in terms of patient care visits, fellowship and residency training programs, and a number of affiliated faculty. The Division is a long-standing participant in research of the neurobiologic basis of addiction disorders, novel addiction treatments, and outcomes research among addicted and dually diagnosed populations. The Divisions’ principal research sites are Bellevue Hospital Center, the VA NYHHS, NYUSOM, and the Nathan Kline Institute.
Mental Health and Addictive Disorders Research Program (NYUSOM and VA NY Harbor Healthcare System)
The Mental Health and Addictive Disorders Research Program, under the direction of Dr. Rotrosen, has over 25 years of experience in biological psychiatry, clinical psychopharmacology and neuroimaging. It has contributed to the successful development of virtually all of the atypical antipsychotic agents, as well as buprenorphine and extended release naltrexone (Vivitrol), and has participated in studies with numerous agents for cocaine and methamphetamine dependence as well as novel agents for attention deficit hyperactivity disorder particularly in adult populations. Dr. Rotrosen was director of the NIDA/VA Medications Development Research Unit in NY and is currently the PI of the New York Node of NIDA CTN New York Node, which conducts studies with both pharmacological and behavioral (and combined) interventions in populations with addictive disorders treated in eight community-based programs in New York City. Together these academic and clinical programs provide expertise in clinical pharmacology and clinical trials implementation as well as a rich source of patient referrals.
Major Equipment {Make sure to tailor this to your grant}
In addition to all standard equipment for molecular and cellular biology, additional equipment housed within the Cardiovascular Research space includes: Leica TCS SP5 confocal microscope; Ion Optix calcium and contractility measuring system; three fully equipped optical mapping stations for measuring voltage- and calcium-dependent activity; animal physiology stations with dissecting binocular microscope (Zeiss); ventilator (Harvard systems); Electrophysiology Station with Medtronic stimulator, NuMED octapolar EP catheters and Biopac monitoring system; Hemodynamics Station with 1.4F Millar catheters; Nanion Port-a-patch high through patch-clamp apparatus; PixCell IIe Laser Capture Microdissection System (Arcturus) laser-capture microscope as well as an ABI Prism real-time PCR system.
Animal {Make sure to tailor this to your grant}
Lab animals are housed within the NYU Langone Medical Center at one of several facilities (Skirball, Berg, Smilow and Dental School), in accordance with the Animal Welfare Act, the U.S. Dept. of Agriculture Regulations and the NIH Guide for the Care and Use of Laboratory Animals. NYULMC has a currently approved Animal Welfare Assurance Agreement with the NIH. Services of full-time veterinarians and ancillary staff are available for investigators in this program.
A fully equipped AAALAC-accredited and staffed animal facility is available at the New York University School of Medicine, Division of Laboratory Animal Resources (DLAR). There are three central vivaria, including two rodent barriers and several ABSL2 areas. The DLAR is staffed by an ACLAM board-certified attending veterinarian, six veterinary medicine staff members, and an additional 40 operational and care staff personnel. Animal care is provided by DLAR seven days a week including emergency veterinary care available 24 hrs/day. There are 3 dedicated surgical suites for large animals and numerous procedure rooms and surgical areas for rodents.
Computers
NYUSOM provides each of the project’s key personnel with individual state of the art computers and printers and have access to the internet via the NYU {or Veterans’ Affairs} network{s}. The computer resources available to and supportive of the academic programs of the School of Medicine are extensive. NYU has the resources to expand access to information necessary for practitioners, teachers and researchers in its educational and clinical networks. The University’s computer resources are located throughout the campus in facilities that include the Academic Computing Facility, the NYU Langone Medical Center, the Frederick L. Ehrman Medical Library, and the Elmer Homes Bobst Library. All are maintained and coordinated by Medical Center Information Technology (MCIT), which manages the campus data communication network, NYU-NET, and provides internet access to the NYU Langone Medical Center community.
Information Technology Services supports over 30,000 users, and 4 general computer labs with a capacity of 400 computers, in addition to an estimated 8,600 networked computers throughout the campus. All certified users have an ID and password to access the Internet, the World Wide Web, email, and a variety of statistical, database, spreadsheet, graphics, and word processing programs. This network consists of high speed Cisco switches and routers using a 10 Gigabit standard. The network connects all computers (both desktop office computers and laptop computers at individual student desks and lab benches), all printers and special devices, including flow cytometry, DNA sequencing and gene expression data storage. The network also allows the use of the central UNIX server farm, centralized storage devices such as IBM DS8300, EMC DMX3, and EMC NS480, and all internet services. NYULMC’s internal systems are protected by state of the art firewall systems including Juniper devices and intrusion detection software (Tipping Point). Full data and system back up capabilities are handled through IBM tape library and TSM backup software. Collaboration and teamwork are supported across multiple institutions using a Microsoft SharePoint architecture behind a secure VPN connection. Other applications are available behind the VPN via a Citrix framework. In addition, high performance computing is performed on Sun Blade 6000 with 10 nodes and 80 cores (64 cores usable). HPC capacity expansion is planned in the coming months.
Databases
Available databases for the conduct of research include: a) Infoshare: a cleaned, friendly set of all released public access social and health related data for NYC, NYS 1980-2010 census data; b) Health and Hospitals Corporation Databases: The public hospitals and clinics in the Southern Manhattan Healthcare Network use an electronic medical record (Misys), housed in a mirrored central server; c) AMDeC: This NY Cancer Project Data Repository is a work in progress and has recruited 18,000 participants (going to 300,000 over 3 years) NY area cancer patients, and provides complex data sets and DNA samples to member’s researchers; {Remove if not applicable: d) Geisinger Health System EMR serves as an integrated provider network located in 31 counties of north central Pennsylvania, with 52 clinic sites, 2 hospitals, 600 employed physician and a catchment area of 2.1 million and uses Epicare as its EMR platform}; e) National and local Veterans Administration Medical SAS Datasets, available indirectly through approved protocols, and various national data extraction sets such as the Veterans Information Resource Center, the Health Economics Resource Center and VA-Medicare Data for Research and; f) NYU’s hospitals utilize a Health Information System which captures all clinical, laboratory, and financial data.
NYU Langone Medical Center High Performance Computing Facility (NYUHPCF)
The NYULMC HPCF provides support services and resources essential for the successful conduct of research within the Department of Population Health. The NYULMC HPCF maintains state-of-the-art resources that combine substantial computing and storage capabilities. Within HPCF we have the computational capacity to perform production, development and benchmarking of high-performance software and algorithms for high-throughput data analytics and scientific computations. In addition, HPCF staff provides consultation on best practices for utilization and current trends in high-performance computing. This allows our researchers to remain current on the state-of-the art in computational platforms and methodology for best utilization of available computing resources specific to their tasks and needs. Our new HPC cluster includes a total of 1170 of the latest Intel processing cores, 5 nodes with latest NVIDIA GPU accelerators (a total of 12,500 cores), a Field Programmable Gate Array (FPGA) server (BEECube) and one high memory server (with 1TeraByte RAM), providing an aggregate of over 10 Terabytes of memory and over 1PetaByte of high-throughput, scalable data storage. In addition, our facility provides access to commercial cloud computing resources.
The NYU General Cluster is a general-purpose high performance computing resource for the NYU research community that offers 2.62 terabytes of memory, large-scale storage options, and a theoretical peak performance of more than 10.5 Teraflops (a trillion calculations per second). The Rocks operating system is used to manage the cluster, which consists of 140 compute nodes and two interactive login nodes, with a total CPU core count of 1,120. Each computer node contains two Xeon Intel Quad-Core 64-bit processors, running at 2.33GHz. The cluster accommodates low latency parallel runs via nodes that are connected with an Infiniband DDR network from CISCO. The General Cluster offers GNU, Intel and MPI compilers, and the Matlab, R, Mathematica, Amber, Gromacs, NAMD, Gaussian 03, VMD applications (additional software may be installed upon request). Home directories are mounted from the control node of the cluster, and there is also a scratch file system accessible from all nodes. For clients with large data needs, there is now an archive file system attached to the clusters' login nodes.
Office Space
Offices and conference rooms assigned for this project are located in the NYULMC Translational Research Building and on the 5th floor of 650 First Avenue. The individual investigators each have their own offices for routine purposes.
The NYU Child Study Center recently relocated its offices to a single facility comprising 73,000 square feet over two floors of One Park Avenue, New York, NY. Our new state-of-the-art office has been designed to meet the needs of researchers, clinicians, educators and administrative staff. It includes 160 offices, 90 research assistant cubicles, seven receptionist/ administrative suites, five fax machines with dedicated lines, six copy machines, sophisticated telephone equipment, four kitchen areas, and extensive filing and storage facilities. There are four testing rooms for seeing subjects, plus two combined treatment/observation rooms for teaching and research. Four conference rooms plus a large central faculty/staff lounge encourage open collaboration among researchers.
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