Participating in NCI sponsored Intergroup trials with the SunCoast CCOP Research Base: Information for Children’s Oncology Group (COG) Clinical Centers
What are Intergroup trials?
- The NCI supports an average of over 1,300 clinical trials a year in the areas of prevention, screening, diagnostics, treatment, quality of life, supportive care, and genetics.
- This research is done primarily through NCI sponsored cooperative groups and Research Bases. Some groups are organized around a specific disease (i.e., gynecologic oncology), some are centered on a particular expertise (i.e., pediatrics), and others have multiple focus areas (i.e., cancer control). What the groups all have in common is that they work to develop and conduct trials in multi-institutional settings.
- In recent years, the NCI has allowed for a limited number of “Intergroup” trials. This means a clinical trial developed by one group may be opened to members of another group. For example, members of COG can have access to specific cancer control trial developed by the SunCoast CCOP Research Base.
- This “Intergroup” mechanism allows for a flexible research agenda and is in response to changing scientific opportunities and new discoveries.
What is the role of the clinical center?
Your role will be to:
- Obtain local IRB approval using the NCI approved protocol and consent model
- Screen participants for eligibility
- Obtain informed consent and register participant through Lead Group’s mechanisms
- Complete treatment per protocol guidelines using Good Clinical Practice Guidelines
- Provide required data to the Lead Group, in this case the SunCoast CCOP Research Base
What are the benefits of becoming a participating clinical site?
Benefits to your site include:
- Access to more Pediatric Cancer Control trials
- Participation provides site with:
- NCI Cancer Control credits, which is used for payment
- A registration that counts towards the minimum number of required registrations to maintain membership with COG
What requirements do COG sites need to meet prior to participating in Intergroup trials?
Your site must:
- Be an active member with COG
- Complete Intent to Participate form
- Fax or email form to the SunCoast CCOP Research Base at the numbers provided on the form
How does reimbursement work?
The SunCoast CCOP Research Base will notify COG of each registration. Your site will be reimbursed by COG based on the credit amount assigned to each study by the NCI. This is the same mechanism used for all cancer control studies regardless of the Lead Group.
If you have any questions about becoming a participating site in the Intergroup trials provided by the SunCoast CCOP Research Base, please contact:
SunCoast CCOP Research Base
Pediatric Epidemiology Center at the University of South Florida
3650 Spectrum Blvd, Suite 100
Tampa, FL 33612
Web site: http://www.suncoastccop.org
Operations Center: 1-800-909-1242