Childhood cancer outcomes have shown truly remarkable improvements in the past 3 decades. Key to this success has been the large-scale participation in multi-centre clinical trials based on the concept that research is a core component of childhood cancer care.
For patients registered on clinical trials, any therapy or management delivered in any setting is considered part of the clinical trial protocol. Thus rigorous requirements around assessment of patients, delivery of care, recording of interventions and compliance with regulatory requirements are required in all settings – including satellites. To meet these requirements, satellite centers must comply with the regulations of the National Cancer Institute Office of Human Research Protection (OHRP), Health Canada, the Children’s Oncology Group (COG) and other regulatory bodies.
Failure to comply with the specified regulatory requirements would lead to one of two outcomes – either the patient would not be enrolled on the relevant clinical trial, OR the patient could not receive treatment in the satellite center.
Pediatric Oncology patients and their families should ideally not be forced to choose between accessing satellite care and enrolling on clinical trials.
This document is intended to define the structure of research participation of satellite patients specifically in phase 2 and 3 trials conducted by the Children’s Oncology Group (COG). The goal of this process is to allow children registered on clinical trials to receive components of care closer to home while still allowing for compliance with all aspects of clinical research within the satellite site.
In addition to this document, the following are essential elements to the conduct of COG trials at satellite sites:
- Master research agreement between each tertiary center and its relevant satellite site(s)
- Tertiary institution delegation of Research Ethics Board (REB) oversight to the Ontario Cancer Research Ethics Board (OCREB) for specific COG phase 2 and 3 studies
- Satellite institution delegation of REB oversight to OCREB for their role as tertiary site affiliates for the conduct of specific COG phase 2 and 3 trials
- Master research agreement per study addendums implemented by tertiary sites in compliance with COG instructions, which extend to the relevant satellite site.
- Access to the overall study protocol document
Primary author Dr. Paul Gibson, Pediatric Oncology Group of Ontario, Toronto, Children’s Hospital, London Health Sciences Centre, London with input from Dr. Jacqueline Halton, Children’s Hospital of Eastern Ontario, Ottawa, Dr. Carol Portwine, McMaster Children’s Hospital, Hamilton Health Sciences, Hamilton, Dr. Mark Greenberg, Pediatric Oncology Group of Ontario, The Hospital for Sick Children, Toronto, Ms. Carla Bennett, Pediatric Oncology Group of Ontario, Toronto, Dr. Sarah Alexander, The Hospital for Sick Children, Toronto, and Ms. Catherine Deveault, The Hospital for Sick Children, Toronto.
Published: December 13th, 2016