This model facilitates the post-approval evaluation of oncology drugs through investigator initiated research. Grants support the exploration of new avenues of clinical investigation that answer important scientific questions and improve patient care. Studies evaluate new combinations of drugs, mechanisms of action of specific agents, drug resistance, or explore extended uses for specific agents. Research is conducted using the following process which is modeled similar to a NIH Study Section:
This model facilitates preclinical, translational, and clinical research for oncology drugs in development. Grants support research performed either as investigator initiated trials or as industry sponsored trials. The investigator holds the IND for investigator initiated trials and the company holds the IND for industry sponsored trials.
The NCCN ORP works with industry collaborators to identify their research needs and facilitates meetings of expert teams to work in one of the following pathways:
Proposal Driven Pathway: This pathway essentially uses the Research Grant Model process in that experts on the RFP Development Team formulate the Request for Proposals (RFPs) to solicit proposals for investigator initiated clinical trials. The NCCN ORP organizes Scientific Review Committees made up of leading peer reviewers to evaluate, score and rank proposals and award funding to the most promising and scientifically meritorious proposals. Since drugs studied in the Drug Development Model are unapproved, the industry collaborator has greater input in clinical trial oversight as it pertains to drug safety and dose escalation issues. The NCCN ORP also provides research services for data monitoring and auditing as necessary.
Protocol Driven Pathway: Experts on a Protocol Development Team (PDT) work hand-in-hand with industry collaborators to develop one or more specific protocols and identify site(s) to conduct studies either as investigator initiated or industry sponsored research. The NCCN ORP: