Clinical Research in Pediatrics at McMaster:

Types, Resources & Support Facilities

Stephanie A. Atkinson, PhD, FCAHS

Professor & Associate Chair, Pediatrics

Associate Member, Dept. Biochemistry & Biomedical Sciences

Professional Staff, McMaster Children’s Hospital

Clinical Research

• Definition

• Funding

• Ethics

• Clinical research at McMaster

– Areas of research

– Facilities

Research Approaches

Hypothesis based scholarly investigation

Basic science

Clinical study

Health services

Epidemiological

Systematic Review

Quality Assurance, Review of Practice

Case reports

Clinical Research Designs

Common Design Objective of Research

Randomized clinical trial Treatment effect

Cohort Prognosis

Cohort, case control,

cross-sectional

Cause

Cohort Incidence

Cross-sectional Prevalence

J. HollandOctober 2009

Clinical Research: Process, Policy, Procedures

PRINCIPAL

INVESTIGATOR

STUDY

MANAGEMENTOVERSIGHT DISSEMINATIONAPPROVALSSCIENCE

CLINICAL RESEARCH

Integrated

Research Services

Health Research

Services

Clinical Department

Research Directors

Peer Scientific

Reviews

Grants

Contracts

Division / Dept

Clinical Services

Clinical Program

HEALTH CANADA

( & / or FDA )

RESEARCH

ETHICS BOARD

Patients

Patient Care policy

Safe Location

Education

Study Audit

& Monitoring

Clinical Research

Site (Nursing,

Beds, Exercise Lab)

Staff Education

Template SOPs

Study Budgets

Data Management

& Biostatistics

Health Care Team:

- Clinical Practice

- Rounds

Research Subjects

Patients:

- Individual Results

- Summary Results

Colleagues:

- Conferences

- Peer review journals

Public:

- Advocacy Groups

- Granting Agencies

- Media

Medical Advisory

Committee

Clinical

Departments

Study Design

(Sponsor; PI)

RESEARCH

ETHICS BOARD

RESEARCH

ETHICS BOARD

5

J Holland 2007

Funding for Research

or Graduate/Postgrad Training

• Tri-Council Federal Agencies

- CIHR/NSERC/SSHRC

• Disease-specific Agencies

• Provincial Agencies

CIHR: 13 Virtual Institutes

Institute of Health Services &

Policy (IHSP): Example of Special Funding

Opportunities from an Institute

• Funding Opportunities launched Jun 24 – 09

• Masters, PhD and Fellowship capacity building

grants in PRIMARY HEALTHCARE

• National and international Catalyst Research

Grants in PRIMARY HEALTHCARE

• Methods and Tools grant to support research

that enables the development and refinement of

research methods and tools

Funding for Research

• Disease-specific agencies

– Heart and Stroke Foundation

– National Cancer Institute

– Canadian Cystic Fibrosis Foundation

– MS Society of Canada

– Juvenile Diabetes Research Foundation International – PDF and early career awards

– Many others……..just google the disease of interest

Funding for Research

• Provincial Agencies

– Ontario Graduate Scholarship

– Center of Excellence for Child & Youth Mental Health at CHEO

– Physician Services Inc – Ontario only

– Alberta Heritage Fdn Medical Research – AB

– Michael Smith Fdn for Health Research – BC

– FRSQ – Quebec only

– Min Health Long-term Care, ON only

Funding Beyond CIHR

• Hospital Foundations, e.g. HHS – most target young investigators – fellows/early career – and only local

• Hospital for Sick Children Foundation – national competition – www.sickkidsfoundation.com

• PSI – www.psifoundation.org

• HSF – www.hsf.ca

• NCE for Child and Youth Mental Health –www.onthepoint.ca

• Michael Smith Foundation for Health Research

Hamilton Health Sciences/Faculty of

Health Sciences

Research Ethics Board (REB)

http://fhs.mcmaster.ca/healthresearch/reb/fo

rms.html

ETHICS in RESEARCH

Mandate of the REB

To protect the rights, safety and well-

being of any patient or healthy

volunteer who participates in research

conducted by a member of the staff of

HHS/Faculty of Health Sciences

Research Ethics Board

Online Documents

• Chart Review Research Application

• General Research Application (Revised: Oct 1, 2009)

• Prospective Database Research Application

• Human Tissue Research Application

• Information and Consent

– General Consent template

– Genetic Consent Template

– Assent Template

– Consent Checklist

ETHICS OF RESEARCH INVOLVING

HUMAN SUBJECTS

AN EDUCATIONAL SEMINAR FOR GRADUATE STUDENTS

CIBC Hall 308/309, Student Centre, McMaster

Thursday October 28, 2010

8:30 a.m. to 1:30 p.m.*

• to introduce graduate students across all faculties and disciplines to ethical issues surrounding

research involving human participants.

FREE - Register online before Oct 27th

http://iserv.mcmaster.ca/ethics/mreb/register/registration.cfm

The Canadian

Road Map:

Tri-Council Policy

Statement

Tri-Council Policy Statement

• REBs

• Privacy

• Conflict of Interest

• Inclusion

• Aboriginal Research

• Clinical Trials

• Fetus

• Tissues

The International Road Map

New Guide to Research in Children

2009

Available at: http://www.mcmaster.ca/ors/ethics/index.htm

• Mechanism of Disease & Disability

• Innovative Management of Childhood Disease

• Health and Quality of Life Outcomes

• Knowledge Translation and Education

http://fhs.mcmaster.ca/pediatrics_research/index.html

Research in Department of Pediatrics

McMaster Child Health Research

• Wet labs for measurement of biomarkers,

tracer studies etc - 5+

• Measurement of nutrition, growth and body

composition in children

• questionnaires, Case Report Forms

• database management

• measurement tools

• knowledge translation

McMaster Child Health Research

ANTHROMPOMETRY – Length/Height

Nutrition, Physical Activity & Health

Length Boards – for use on

flat counter tops

- Premature infant

- Term infant

- Child to 2 years

Stationary Wall-mounted Stadiometer

Anthropometric Equipment for Pediatric

Clinical Research Unit

Body Composition in Children

• Bioelectrical Impedence

• Calipers for skin fold thickness

• DXA –- Dr. Atkinson - located in HSC 4U18 with specialized infant software

Anthropometric Equipment for Pediatric

Clinical Research Unit

Pea Pod by Life

Measurement, Inc

• Will be available by

Dr. Fusch for use both

within the NICU and

outside of it for

measures in infants

up to 6 months of age

Exercise Capacity Measures

Dr. Timmons’ Lab

Exercise Physiology

Lab at CENC

Clinical Research

Definition

Funding

Ethics

Clinical research at McMaster

– Areas of research

– Facilities