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U.S. National Institutes of Health
Last Updated: 06/02/14

CTEP Major Initiatives

An Overview of NCI’s National Clinical Trials Network
On March 1, 2014, after several years of extensive consultation and coordination with many stakeholders, NCI transformed its longstanding Cooperative Group program into the new National Clinical Trials Network (NCTN). More…

Institute of Medicine (IOM) Recommendations – NCI Clinical Trials Cooperative Group Program
Learn more about the process NCI has put in place recently to take the beginning steps in transforming the Cooperative Group Program. More…

Restructuring NCI Clinical Trials Prioritization Process – Steering Committees
The Disease-Specific Scientific Steering Committees will leverage existing Intergroup, Cooperative Group, SPORE, and Cancer Center structures for each major disease area as well as for pediatric oncology and symptom management/supportive care to address, design and prioritize phase 3 trials. More…

Phase 1-2 Early Drug Development
The CTEP Early Drug Development Program (EDDP), under the direction of the Investigational Drug Branch, carries out drug development plans for investigational agents held under CTEP IND, in collaboration with industry, academia, and the NCI intramural program. CTEP currently holds approximately 80 active INDs, with more than 500 phase 1-2 clinical trials. More…

Pharmaceutical Collaborations
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. More…

Cancer Trials Support Unit (CTSU)
The Cancer Trials Support Unit (CTSU) is a service of the National Cancer Institute’s (NCI) Cancer Therapy Evaluation Program (CTEP). More…

The Children’s Oncology Group (COG) Phase I/Pilot Consortium
The consortium’s primary objective is to expeditiously develop and implement pediatric phase I and pilot studies, thus facilitating the integration of advances in cancer biology and therapy into the treatment of childhood cancer. The consortium includes approximately 20 pediatric COG institutions with expertise and experience in developmental therapeutics. More…

Adult Brain Tumor Consortium
The Adult Brain Tumor Consortium (ABTC) is a new multi-institutional consortium created from the consolidation of two previous, separate NCI-funded consortia: the New Approaches to Brain Tumor Therapy (NABTT) and the North American Brain Tumor Consortium (NABTC). The newly formed ABTC permits NABTT and NABTC investigators to continue their research, but focuses management of their clinical program into a single entity.More…

Pediatric Brain Tumor Consortium
The Pediatric Brain Tumor Consortium (PBTC) was formed by the National Cancer Institute (NCI) in 1999 as a clinical trials organization dedicated to translating innovative therapies from the laboratory to early phase clinical testing so that treatment for primary brain tumors in children can be improved. More…

Organ Dysfunction Studies
The Cancer Stem Cell (CSC) Therapeutics Initiative will evaluate agents (GSIs, kinase inhibitors, DLL ligand inhibitors, antibodies, disruption of protein interactions) that target the cancer stem cells/progenitor cells and their altered embryonic signaling pathways, with a particular emphasis on Hedgehog (SHh), notch and wnt signaling. More…

Central Institutional Review Board Initiative (CIRB)
The Central Institutional Review Board Initiative (CIRB) provides an innovative approach to human subject protection through a “facilitated review” process that streamlines local IRB review of adult and pediatric national multi-center cancer treatment trials. More…

Pediatric Preclinical Testing Program (PPTP)
The NCI-supported Pediatric Preclinical Testing Program (PPTP) is a comprehensive program to systematically evaluate new agents against childhood solid tumor and leukemia models. The PPTP is supported through an NCI research contract to St. Jude Children's Research Hospital (SJCRH) with Dr. Peter Houghton as the Principal Investigator. More…

International Trials – NCIC, EORTC, IBCSG and others
As improvements in cancer treatment have led to increased survival, the need for expanded collaboration on treatment trials has correspondingly increased. First, new active treatments which prolong survival in turn often require larger sample sizes to detect potential benefit from experimental regimens or to determine the similar efficacy of a less toxic regimen. Second, developments in molecular biology have allowed the use of molecular markers to define patient cohorts based on tumor biology, “splitting” rather than “lumping” histologically-defined cancer populations into smaller genomically-defined diseases. More…

Common Terminology Criteria for Adverse Events
Cancer Therapy Evaluation Program (CTEP) developed the original Common Toxicity Criteria (CTC) in 1983 to aid in standardizing the description of adverse events (AEs) and grading the severity of those events for oncology clinical trials with therapeutic interventions. More…

CTEP Early Drug Development (EDD) Meeting
CTEP sponsors two semi-annual investigator meetings, in the spring and fall of each year. These meetings generally last one and a half days and are held either on the NIH Clinical Center campus (e.g. Natcher auditorium) or in a nearby hotel. The meeting is intended as an educational event and is focused on enhancing communications between the NCI and the network of CTEP-supported UO1 and NO1-funded early clinical trial investigators.More…

Michaele C. Christian Oncology Development Lectureship and Award
This award was established by the Cancer Therapy Evaluation Program in 2007 to honor the twenty year NCI career of Michaele C. Christian. Dr. Christian was appointed Associate Director of the Cancer Therapy Evaluation Program of DCTD in 1997 after serving as head of the Investigational Drug Branch overseeing the clinical development of novel anticancer agents. More…

The Childhood Cancer Survivor Study
The Childhood Cancer Survivor Study (CCSS) is a collaborative, multi-institutional study funded by the National Cancer Institute since 1993. The goal of CCSS is to investigate the long-term morbidity and mortality associated with the treatment regimens for children and adolescents treated for cancer during the past 30 years. More…

Collaboration with NHLBI on the BMT-CTN
The Blood and Marrow Clinical Trials Network (BMT CTN) is supported by a U01 grant to the NHLBI and NCI, with the NHLBI as the lead institute. NIAID also supports one of the trials. This network is managed jointly among NHLBI and NCI/CTEP program officers. More…