The goal of the Cancer Therapy Evaluation Program (CTEP) is to facilitate the process of bringing promising, novel, investigational anticancer agents to the public as quickly and as safely as possible. As part of meeting that goal, CTEP actively seeks collaborations with pharmaceutical and biotechnology companies, specifically to complement or enhance their clinical development plans, thereby expediting the development of promising agents. CTEP offers a unique combination of resources and expertise, including the ability to evaluate agents in a wide variety of tumor types and disease settings. Collaborative agreements provide the Industry partner with exclusive use of all data from clinical trials for regulatory filings and agent development, an option to elect a license to any intellectual property that might arise from the clinical trials and a unique way to leverage resources in the conduct of clinical trials. CTEP files an IND for all studies conducted under a collaborative agreement, thereby assuming all of the regulatory responsibilities for the conduct of the studies. All data is shared with the Industry partner.
An important part of CTEP’s goal is to enhance therapeutic benefit by rationally combining investigational agents based on their purported mechanism of action. CTEP has over 100 INDs filed with the FDA and has about 75 active collaborative agreements. Therefore, CTEP is uniquely positioned to negotiate with more than one Industry Collaborator in order to use multiple investigational agents in a single clinical trial. Each Industry Collaborator is provided with access to the data and there are intellectual property provisions in each agreement to foster these combination studies. The success of this program is evidenced by the increasing number of active combinations protocols each year. There are currently over 100 such studies with many more approved or in development. In addition, CTEP has included combination studies as part of the solicitations for new studies issued for many of the new agents entering the program.