NCI Web site
Dictionary of Cancer Terms
NCI Drug Dictionary
NCI Clinical Trials Information
Programs & Activities
Drug Development
For more than 25 years the NCI Liaison Office has assisted with the international exchange of information and new experimental cancer drugs of mutual interest at all stages of preclinical and clinical evaluation. European Collaborative Agreements have been signed with EORTC and Cancer Research UK (CRUK) to define the role of each organization in the development of new anticancer drugs. High priority drug candidates may, by mutual agreement, be assigned to any appropriate CRUK, EORTC, or NCI laboratory or clinic that can aid in or carry out a necessary step in the development of the agent.
Preclinical Development
Preclinical collaborative agreements with European institutions are providing important expertise on experimental tumor models development, human tumor cell lines, and xenografts to NCI. These collaborative groups (EORTC Drug Development Committee and Pharmacology & Molecular Mechanisms Groups) also provide secondary evaluation of potentially effective anticancer drugs originating from the NCI in-vitro screening program, in collaboration with the NCI Developmental Therapeutics Program (DTP).
Approximately 20 percent of all potential new anticancer compounds submitted worldwide to the NCI screening program have been acquired by the NCI Liaison Office from European sources. The office has kept contacts with more than 600 European suppliers from over 26 countries. A Web-based submission and selection process is now available via the DTP web site. The NCI Liaison Office continues to assist European suppliers with inquiries related to the submission and further investigation of their compounds by DTP.
Clinical Development
With the assistance of the NCI Liaison Office, the NCI’s Cancer Therapy Evaluation Program (CTEP) has been instrumental in facilitating cross-Atlantic joint clinical studies. The NCI’s standard protocols and guidelines for clinical investigations have been adopted by EORTC, CRUK, and SENDO, and clinical research is now conducted according to standards compatible with those adopted by Phase I and Phase II groups in the United States. The European institutions have registered their Drug Master File with the US FDA, thus facilitating the filing of IND applications and their approval by the US FDA based on preclinical and clinical data from Europe. Both CRUK and EORTC have obtained International Cooperative Project Assurance (ICPA) certificates from the US Alliance for Human Health Research Protections (AHRP).
Via the NCI Liaison Office, CTEP investigators serve as advisors to the EORTC Protocol Review Committee in providing expert advice on Phase III protocol outlines.
