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International Randomized Trials in Orthopaedic Oncology : Joining Forces and Shifting the Paradigm. Michelle Ghert, MD, FRCSC Center for Evidence-Based Orthopaedics McMaster University. Disclosure. Committee Chair: Orthopaedic Research Society

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international randomized trials in orthopaedic oncology joining forces and shifting the paradigm

International Randomized Trials in Orthopaedic Oncology: Joining Forces and Shifting the Paradigm

Michelle Ghert, MD, FRCSC

Center for Evidence-Based Orthopaedics

McMaster University

disclosure
Disclosure
  • Committee Chair: Orthopaedic Research Society
  • Committee Member: Musculoskeletal Tumor Society
  • Grand Funding: OREF, MSTS, PSI, CCSRI, MSA
  • Private Funding: Manherz Family Donation
overview
Overview
  • Learning Process
  • Take Home Points:
    • Trials require: 1. The right question

2. Centralized infrastructure

3. Collaborative network

slide7

First ever

Department of Clinical Epidemiology

Chairman: Dr. David Sackett

Dr. David Sackett

M.S. from Harvard Epidemiology

Mentor

Dr. Gordon Guyatt

Coined the term “Evidence-Based Medicine”

Mentor

Dr. Mohit Bhandari

Unparalleled transformation in orthopaedic research

Prospective international randomized controlled trials

Mentor

will it work
Will it work?
  • Trials require: 1. The right question

2. Centralized infrastructure

3. Collaborative network

slide14

SPRINT trial: 1339 patients, 95% follow-up

  • FLOW trial: 2500 patients recruited, target 2520
  • FAITH trial: 990 patients, target 1000
  • TRUST trial: 500 patients, target 1000
  • HEALTH trial: 358 patients, target 1400
  • INORMUS and PRAISE cohorts: 7900 patients
  • Collaboration with over 150 centers around the world
preliminary steps for a surgical trial
Preliminary Steps for a Surgical Trial
  • Find an important question
  • Systematic review
  • Survey the field
  • Publish a protocol
  • Apply for funding
clinical question pico
Clinical Question: PICO

Population

Intervention

Comparison

Outcome

preliminary steps for a surgical trial1
Preliminary Steps for a Surgical Trial
  • Find a question important to your field
  • Systematic review
  • Survey the field for practice and opinion
  • Publish a protocol
  • Apply for funding
preliminary steps for a surgical trial2
Preliminary Steps for a Surgical Trial
  • Find an important question
  • Systematic review
  • Survey the field
  • Publish a protocol
  • Apply for funding
preliminary steps for a surgical trial3
Preliminary Steps for a Surgical Trial
  • Find an important question
  • Systematic review
  • Survey the field
  • Publish a protocol
  • Apply for funding
study design
Study Design

Standard pre-op and intra-op antibiotics

AND 24 hours post op antibiotics

Follow-up one year

Follow-up one year

Patient screened and eligible and provides informed consent

Randomization

Standard pre-op and intra-op antibiotics

AND 5 days post op antibiotics

sample size calculation
Sample Size Calculation
  • Infection rate: 10%
  • Superiority of long-term antibiotics:
    • threshold of 5% for inferiority
  • Estimated sample size of 920
preliminary steps for a surgical trial4
Preliminary Steps for a Surgical Trial
  • Find an important question
  • Systematic review
  • Survey the field
  • Publish a protocol
  • Apply for funding
what you need to run rcts
What you need to run RCTs
  • Trials require: 1. The right question √

2. Centralized infrastructure

3. Collaborative network

what you need to run rcts1
What you need to run RCTs
  • Trials require: 1. The right question √

2. Centralized infrastructure

3. Collaborative network

methods center
Methods Center

Nominated Principal Investigator

Co-Investigators

Senior Biostatistician

Study Coordinator

Administrative Assistants

Statistician

Graduate Students

Data Manager

Research Assistants

slide51

PARITY Trial Organization

STEERING COMMITTEE

Overall responsibility for the trial

CENTRAL ADJUDICATION COMMITTEE

Review and classification of all

clinical events

DATA MONITORING COMMITTEE Review of adverse events and stopping rules based on benefit and harm

METHODS AND COORDINATING CENTRE

Data management, daily conduct of the trial

PARTICIPATING CLINICAL CENTRES Patient recruitment and follow-up as per study protocol

methods center personnel
Methods Center Personnel

Nominated Principal Investigator

Co-Investigators

Senior Biostatistician

Study Coordinator

Grants Administrator

Statistician

Graduate Students

Data Manager

Research Assistants

principal investigator
Principal Investigator

Nominated Principal Investigator

Co-Investigators

Senior Biostatistician

Study Coordinator

Grants Administrator

Statistician

Graduate Students

Data Manager

Research Assistants

co investigators senior biostatistician
Co-Investigators, Senior Biostatistician

Nominated Principal Investigator

Co-Investigators

Senior Biostatistician

Study Coordinator

Grants Administrator

Statistician

Graduate Students

Data Manager

Research Assistants

study coordinator
Study Coordinator

Nominated Principal Investigator

Co-Investigators

Senior Biostatistician

Study Coordinator

Grants Administrator

Statistician

Graduate Students

Data Manager

Research Assistants

statistician
Statistician

Nominated Principal Investigator

Co-Investigators

Senior Biostatistician

Study Coordinator

Grants Administrator

Statistician

Graduate Students

Data Manager

Research Assistants

data manager
Data Manager

Nominated Principal Investigator

Co-Investigators

Senior Biostatistician

Study Coordinator

Grants Administrator

Statistician

Graduate Students

Data Manager

Research Assistants

graduate students
Graduate Students

Nominated Principal Investigator

Co-Investigators

Senior Biostatistician

Study Coordinator

Grants Administrator

Statistician

Graduate Students

Research Assistants

Data Manager

research assistants
Research Assistants

Nominated Principal Investigator

Co-Investigators

Senior Biostatistician

Study Coordinator

Grants Administrator

Statistician

Graduate Students

Research Assistants

Data Manager

grants administrator
Grants Administrator

Nominated Principal Investigator

Co-Investigators

Senior Biostatistician

Study Coordinator

Grants Administrator

Statistician

Graduate Students

Data Manager

Research Assistants

what you need to run rcts2
What you need to run RCTs
  • Trials require: 1. The right question √

2. Centralized infrastructure √

3. Collaborative network

what you need to run rcts3
What you need to run RCTs
  • Trials require: 1. The right question √

2. Centralized infrastructure √

3. Collaborative network

slide70

PARITY Trial Organization

STEERING COMMITTEE

Overall responsibility for the trial

CENTRAL ADJUDICATION COMMITTEE

Review and classification of all

clinical events

DATA MONITORING COMMITTEE Review of adverse events and stopping rules based on benefit and harm

METHODS AND COORDINATING CENTRE

Data management, daily conduct of the trial

PARTICIPATING CLINICAL CENTRES Patient recruitment and follow-up as per study protocol

parity investigators
PARITY Investigators

Michelle Ghert, Benjamin Deheshi, Gita Sobhi, Peter Ferguson, Jay Wunder, Robert Turcotte, Joel Werier, Paul Clarkson, Marc Isler, R. Lor Randall, Ginger Holt, Megan Anderson, John Healey, Marcos Galli, Rob Grimer, Tom Scharschmidt, Ed Chang, Benjamin Miler, Norbert Dion, SevanHopyan, Rob Pollock, GraigGerrand, William Aston, Max Gibbons, John Abraham, Tessa Balach, Paul Cool. MinnaLaitinen, YairGortzak, Yoshihiro Nishida, TabuGokita, Doran Frantzen, Leonard Marais, Matthew DiCaprio, Felix Cheung, Howard Rosenthal, Ernest Conrad, Timothy Damron, Joseph Benevenia, Mark Gebhardt, Sophie Mottard, Nathan Evaniew, AntonellaRacano, Sheila Sprague, Marilyn Swinton, Dianne Bryant, LehanaThabane, Gordon Guyatt, MohitBhandari

take home points
Take Home Points
  • Trials require: 1. The right question

2. Centralized infrastructure

3. Collaborative network

  • Collaboration is the foundation of RCTs, without which the endeavour will collapse