Division of Pediatric Clinical Research

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Division of Pediatric Clinical Research

• Batchelor Children's Research Institute
• 5th Floor

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Introduction Philosophy

• Tracie Miller, MD, MS
• Division Director

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Mission

• The Division of Pediatric Clinical Research is
  dedicated to
• The development and conduct of the highest
  quality interdisciplinary pediatric clinical
  research
• Establishing UM and its faculty as national
  leaders in child health research

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Goals (1)

• To promote cutting-edge research that will result
  in improved child health
• To encourage interdisciplinary research across
• Divisions, departments, and schools within the
  University of Miami
• Link the department to other institutions and
  organizations regionally, nationally, and
  internationally

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Goals (2)

• To create a collaborative and supportive academic
  research environment and infrastructure
• To secure extramural funding from institutions
  ranging from the NIH to private foundations and
  industry

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Infrastructure

• We have over 30 faculty and staff who are
  positioned to facilitate research
• We centralize resources and expertise to maximize
  organizational efficiency resulting in high
  quality services

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Current Personnel Include

• Director
• Division Manager
• Grants Administration Specialists
• Near Full-Time Research-Oriented Physicians
• Faculty Biostatisticians
• Faculty Epidemiologists
• Database Analysts
• Research Dietician
• Research Exercise Physiologists
• Experienced Research Study Coordinators

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Clinical Research Administration Supports the
Division to

• Consult with Investigators who need assistance
• Research Opportunities for Investigator Interests
• Develop new Community/Academic Programs
• Liaison with Pediatrics Administration
• Assist with Interdepartmental Grant Submissions
• Oversee General Building and Office Operations
• Provide Faculty and Staff Support
• Schedule visiting professors for presentations

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Exercise Rehab CrunchTime UMMG
DXA Bone Density Scans
Clinical Programs
Pediatrics Division of Clinical Research
Planning Scheduling of Visiting Professors
Weekly Luncheon Seminar Series
Research Support
Administrative Support for Staff and Faculty
Research Opportunities Tracking Database
Consulting Services Support for Investigators
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Epidemiology

• Jay Wilkinson, MD, MPH
• Senior Faculty Epidemiologist

Sarah Messiah, PhD, MPH Faculty Epidemiologist
WayWay Hliang, PhD Faculty Epidemiologist
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What Exactly IS Epidemiology?

• Study of distribution and determinants of
  disease/health-related states in populations
• Classifying/categorizing disease
• Defining a population at risk
• Measuring disease frequency

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What Does an Epidemiologist Know?

• Clinical Medicine - emphasis on disease
  classification and diagnosis
• Public Health - emphasis on disease prevention
• Pathophysiology - basic biological mechanisms of
  disease
• Social Sciences - social context in which disease
  occurs
• Statistics - to quantify disease frequency,
  relationships with antecedents

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What an Epidemiologist Can do for You

• Research Design
• Power Analysis
• Project/grant development (specific
  aims/supporting hypotheses)
• Manuscript Development and Submission

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Biostatistics

• David A. Ludwig, PhD
• Senior Biostatistician

Gabriella Lopez-Mitnik, MS, MPhil Masters
Biostatistician
Kristopher L. Arheart, EdD Senior Biostatistician
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Overall Design Strategy

• Formulation of Research Goals/Aims/Objectives
• Operational definition of these goals and
  objectives
• Quantification and measurement of the operational
  definitions
• Design aspects of data collection and
  experimental manipulation or survey methodology
• QA/QC strategies during the study
• Liaison with data base management specialists
• Statistical programming tracked to the goals
  and objectives
• Interpretation and presentation of statistical
  outcomes

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General Areas of Expertise

• Design and Analysis of Experiments and
  Observational Studies (Clinical Trials, Power
  Analysis)
• Statistical Programming (SAS, StatExact)
• Statistical Modeling (GLM, Neural Nets)
• Graphics (2-D, Motion)
• Computer Intensive Methods (Bootstrap, Monte
  Carlo Simulation)
• Psychometrics (Scale Evaluation Construction)
• Multivariate Methods (Data Reduction, Mining)
• Epidemiological Risk Assessment (Contingency
  Tables, Logistic Models)
• Sampling (SRS, Complex)

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Areas of Application

• Grants and Contracts
• Manuscripts
• Oral Presentations
• Posters
• Program Evaluation

YOU CANT DO THAT!!!
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Data Management Database Development

• Maria Y. Marin, MIT
• Senior Database Analyst

Sunil Mathew Database Tech. Specialist II
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Database Design

• Consult with P.I.s, biostatisticians, and
  epidemiologists on study objectives and
  narratives
• Deliver an effective DBMS solution
• Create an initial backend to the database
  (tables, fields, properties) based on study
  requirements
• Create a conceptual data model that will allow
  for data to be linked by relationships

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Database Development

• Develop the user interface to simulate case
  report forms
• Program internal controls (ranges, constraints,
  and calculations) to protect accidental data
  entry
• Develop detailed and summary reports
• Beta test the database for data accuracy and
  user-friendliness

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Database Administration

• Host the database on the server to allow for
  multiple users to access the database
  simultaneously
• Set up appropriate user accounts and privileges
• Perform daily and weekly backups
• Continuously update and/or modify the database
  based on changes to the study

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Databases Designed and Developed

• Research Database
• Nutrition Study Database, Tracie Miller, M.D.
• Safe-Labor Database, Victor Gonzalez-Quintero,
  M.D.
• Early Discovery Database, Susan Gold, M.D.
• Pediatric Heart Failure Database, Paolo Rusconi,
  M.D.
• Administrative Databases
• Research and Research Related Accounts Database,
  Department of Pediatrics
• Project Tracking Database, Division of Clinical
  Research
• Reminder/Recall Database, Pediatrics Mobile
  Clinic
• Foundation and P.I. Interest Tracking Database,
  Department of Pediatrics

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Database Support

• Assist in design, modifications, and scripting of
  databases
• Install and update database applications on
  client stations
• Configure client systems to access the server
  hosting the databases
• Assist with database server management,
  maintenance, and updates
• Database software training

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Research Grants Funding

• Ivonne Rivera
• Administrative Assistant

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Research Grant Opportunities

• Obtain P.I.s disease interest through the
  Faculty Interest Survey distributed via email to
  Pediatrics faculty.
• Input P.I.s interest in the Foundation Tracking
  Database for future grant opportunities.
• Research and Match grant opportunities to the
  appropriate P.I.s interest for alerts received
  from private or government funding announcements
  such as Listserve, NIH, RWJF, Index of Diseases,
  etc. based on the PIs Faculty Interest Survey
  response.
• Notify faculty members of foundation name, award
  amount, application deadlines and brief
  description of the announcement.

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Research Grant Opportunities

• Research interests can be added and or updated at
  any point in time.
• Email Contact irivera_at_med.miami.edu

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Project Coordination

• Gabriel Somarriba
• Exercise Physiologist Senior Research Associate

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Who We Are

• DPCR we have 11 coordinators
• Vast experience in all aspects of a research
  project
• We are familiar with Jackson procedures
• IATA certified to ship biological samples
• We have contacts in HSRO, GCRC, pharmacy, local
  labs, labs around the country
• Between all of us, we do get everything done

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How We Can

• A coordinator may be used for 10 of their time
  to 100, depending on your needs
• May be involved from protocol development to
  manuscript submission
• Roles range from data entry to phlebotomy
• IRB whether you have a multi center trials that
  go to WIRB, transferring studies back to UM, new
  protocols at UM, and any other procedures, we
  have done those at both sites

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What We Ask of

• Review all documents
• Documents we need
• CITI (up to date), CV, Medical license
• Submit COI
• These limit protocols, amendments, continuing
  reports from going to board
• Meet to discuss progress/responsibilities

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Clinical Programs

• Tracie Miller, MD, MS
• Division Director

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Facilities

• 2 Patient Examination Rooms
• Nurses Station
• Body Composition Laboratory
• Cardiac Evaluation Laboratory
• Exercise Rehabilitation

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Clinical Facilities - Functions
Clinical Facilities - FUNctions

• Industry-sponsored protocols
• Other clinical protocols
• Commercially available exercise rehabilitation
  program (CRUNCHTIMETM)
• Commercially available bone mineral density and
  body composition laboratory

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Administration

• Christie Vila, PhD
• Division Manager

Ivonne Rivera Administrative Assistant
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Accessing Consulting Services DPCR faculty and
staff will assist you with proposals or research
in progress on a case by case basis Please
Contact Christie K. Vila, PhD cvila_at_med.miami.edu
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Examples of Consulting Services

• Successful Partnerships in Grant Submissions
  with
• Investigators from most UMMSM departments
• Miami Childrens Hospital
• Department of Defense funded projects
• Agatston Research Foundation South Beach
  Diet/HOPS
• Services Provided
• Biostatistics support on proposals and ongoing
  research
• Project coordination and IRB support
• Database management, programming, and support
• In-house IT support
• Epidemiological advisement
• Manuscript preparation

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Clinical Research Seminar Series

• Natalya Bublik, MPH
• Research Associate III

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About Clinical Research Seminars

• Take place every Wed, 12 1 PM, Sept May
• Examples of Seminar Topics (2007-2008)
• Stem Cell Transplant Research
• Public Policy and Epidemiology of Intellectual
  Disability
• Grant Writing 101
• Preventing Tobacco Initiation in Children and
  Promoting Tobacco Cessation in Parents
• Culturally Sensitive Education for Parents in
  NICU
• Designing Clinical Interventions to Prevent
  Obesity in Young Children
• Blood Pressure Changes from Childhood to
  Adolescence
• Development of Novel Treatment Strategies for CNS
  Leukemia

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About Clinical Research Seminars

• Examples of Speakers
• Matt Gillman, MD Harvard School of Medicine and
  Public Health
• Stephen Daniels, MD, PhD University of Colorado
  Denver School of Medicine
• Arthur Agatston, MD Creator of South Beach Diet
• Julio C. Barredo, MD Director, Division of
  Pediatric Hematology-Oncology, UM
• Steven E. Lipshultz, MD Chairman of Pediatrics,
  UM
• Paolo Rusconi, MD Medical Director, Pediatric
  Heart Failure and Transplant, UM

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About Clinical Research Seminars

• Good place to share research ideas, ongoing
  projects, research dilemmas, etc.
• Great way for everyone to learn about research
  studies happening at UM and elsewhere
• Opportunity for our speakers
• To get some feedback on their projects
• To establish collaborations
• To communicate with other investigators to help
  recruit patients for the studies

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About Clinical Research Seminars

• Please RSVP to attend our seminars
• Contact me to be added to our distribution list
• Natalya Bublik
• nbublik_at_med.miami.edu
• [phone]

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Questions ?
The Division of Pediatric Clinical Research
Thanks for visiting
Contact Us cvila_at_med.miami.edu 305-243-1423