Multisite Networks Collaboarating with a U.S. Cooperative Group
How do multisite networks collaborate with U.S. cooperative groups?
NCI-sponsored clinical trial cooperative groups in the U.S. conduct joint trials with cooperative groups based outside the United States. These groups have sites in South America, Asia, Africa, Australia, and New Zealand. Some examples of international multisite network partners are:
- European Organisation for Research and Treatment of Cancer (EORTC)
- National Cancer Research Institute (NCRI) in the United Kingdom
- Medical Research Council (MRC) in the United Kingdom
What are the regulatory requirements for this type of collaboration?
The regulatory requirements may vary for each individual trial. Variables that affect the regulatory requirements include:
- Whether the trial has potential pharmaceutical licensing implications
- Whether the trial involves experimental agents
- Whether the trial requires centralized collection of tumor specimens for analysis at a core laboratory.
In addition, the participating groups must reach agreement on:
- Plans for quality control/quality assurance
- The need for on-site audits to verify original source documentation
- Plans for pooling of data prior to analysis
- Authorship of manuscripts arising from the trial.
How can I explore this type of collaboration further?
Investigators from cooperative groups based outside the United States who would like to explore opportunities for collaboration in clinical trials with a U.S.-based cooperative group can contact that group directly. A list of NCI-sponsored cooperative groups is available on the NCI Web site.
Alternatively, you can contact the NCI CTEP staff member associated with your area of investigation. A list of CTEP staff can be found in the Protocols section of this website.