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EORTC AISBL / IVZW |
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EORTC AISBL / IVZW |
The National Cancer Institute (NCI) is the leading US agency for cancer research and treatment in the United States and is part of the National Institutes of Health (NIH). The NCI was established by the US Congress in 1937 and its programmes were intensified in 1971 after passage of the National Cancer Act. The vast majority of NCI funds (80%) go as grants and contracts to universities, medical schools, cancer centers, research laboratories and private companies. The NCI supports scientists all over the world in a broad range of research activities.
European-NCI Collaborative Activities
A history of more than three decades of coordinated cancer treatment research between the EORTC and the NCI has brought great opportunities for more efficient development of new cancer therapeutics.
As part of the NCI’s global strategy, the NCI Liaison Office in Brussels was created in 1972, to search
for potential new anticancer substances from European sources. The Office expanded quickly and has
been pivotal in moving Europe and North America closer to a common linked network.
A European Collaborative Programme initiated with the EORTC in the early 70’s continues to be
highly successful in promoting the exchange of information on new drugs for both pre-clinical and
clinical evaluation. Compound acquisition, selection, screening, formulation, toxicology, and the clinical
evaluation are now well integrated between Europe and the USA. Much of this success in new drug
development has been facilitated by the close working relationship between the NCI, the EORTC, and
the British Cancer Research United Kingdom (CRUK) in London.
European Collaborative Agreements
Collaborative Agreements signed between the NCI and the EORTC, CRUK, and the Southern Europe New Drugs Organization (SENDO) in Italy define the role of each organisation in the clinical development of new anticancer drugs. This expanded international collaboration also includes the exchange of information and new drug candidates of mutual interest at all stages of pre-clinical and clinical evaluation.
High priority drug candidates may, by mutual agreement, be assigned to any appropriate CRUK,
EORTC, SENDO or NCI laboratory or clinic that can help with or carry out a necessary step in
the development of the agent. Drugs are now developed in such a way that they may enter clinical
trials on either side of the Atlantic. Initial clinical trials are conducted according to mutually-agreed
protocols and in compliance with appropriate standards for the testing of experimental agents, so
as to facilitate the acceptability of data on Phase I results by the appropriate regulatory authorities.
Joint guidelines on pharmaceutical formulation were published in the European Journal of Cancer and
Clinical Oncology. Based on the current state-of-the-art, joint guidelines on pre-clinical toxicology are
made available and updated as necessary.
By mutual agreement this collaboration has been extended to provide new compounds of European origin from the NCI in-vitro anticancer screening programme to the European collaborative groups. A review and selection committee composed of members of EORTC, and CRUK has so far reviewed the data on more than 1000 compounds, of which numerous substances have been considered as being of interest for potential further anticancer evaluation in Europe.
With the registration by the EORTC and CRUK of their Drug Master Files with the FDA, and thus
the recognition by the FDA of the leading European centers, it is now well recognized that the
preclinical studies as well as the clinical trials carried out under the collaborative programme meet
the requirements of the various regulatory agencies both in Europe and the United States. Over
the past years, it has become common practice for the FDA to approve Investigational New Drugs
(INDs) based on European studies carried out under these guidelines, as is documented by numerous
examples. In March 2001, the FDA published a document “Guidance for Industry-Acceptance of
Foreign Clinical Studies”. This document represents an important official recognition of what the NCI
Liaison Office has been promoting for European clinical studies carried out by NCI’s collaborators.
In order to facilitate the cooperation with the North American Cancer collaborative groups, the
EORTC has been affiliated with the Office of Human Research Protection (OHRP) since 1998.
Since 1998, the legal framework for clinical trials has been significantly revised on both sides of the
Atlantic.
In December 2004, the NCI developed new regulatory guidelines with the Cancer Therapy Evaluation
Programme (CTEP) for the conduct, development and analysis of clinical trials with international
collaborating institutions.
Within the framework of these newly developed CTEP guidelines and gratefully to the existing
affiliation of the EORTC with the OHRP, transatlantic cooperation has been facilitated significantly.
The NCI Liaison Office (NCILO)
The NCI Liaison Office (NCILO) in Brussels, Belgium, situated adjacent to the EORTC headquarters, is part of the Office of International Affairs, NCI, and is an integral part of the NCI. Its role is to act as a European-based link to NCI cancer research and treatment programmes in the United States. It facilitates the interchange of information, ideas, experimental drugs, scientific expertise and scientists between Europe and the US NCI. It works in close collaboration with the EORTC, the British Cancer Research UK (CRUK) and the Southern Europe New Drugs Organization (SENDO) in Italy, as well as with other European cancer research institutes and pharmaceutical/chemical industries. Its role is to help create a network of cancer experts and cancer centers between Europe and the US NCI which work towards a common goal, to enable rapid progress in cancer research on an international scale.
Through the NCI Liaison Office, the NCI is represented on numerous European committees involved
in new drug development, as well as on the EORTC Board and General Assembly and the CRUK Ph I/II
clinical trials committee. The Office participates in working groups that disseminate cancer research
and drug development information throughout Europe.
The Office assists with the acquisition of new agents from Europe for NCI’s screening programmes, and supports an international exchange of experimental drugs for pre-clinical and clinical evaluation.
Up until the transition over to a web-based submission procedure, the NCI Liaison Office acquired
approximately 2000 compounds per year from European sources for NCI’s in-vitro anticancer
screening programme. Pre-clinical collaborative agreements with European institutions, administered
by the Office, are providing important expertise on experimental tumour model development, human
tumour cell lines, and xenografts. These collaborative groups (i.e. Drug Discovery Committee of
the EORTC Pharmacology and Molecular Mechanisms Group) also provide secondary evaluation of
potentially effective anticancer drugs originating from the NCI in-vitro screening programme.
The Office also assists other NCI divisions and programmes with their European activities, such
as exchange and support programmes. Furthermore, the Office collects European cancer research
protocols for the NCI Cancer Information Products and Systems (CIPS) Programme, Office of
Communications, NCI, for inclusion in NCI’s clinical database PDQ (Physician Data Query/Cancer
Net ®). PDQ is a database which contains information on cancer treatment research. PDQ allows
investigators to have access to both ongoing US and European protocols. In addition to the clinical
studies under EORTC auspices, the inclusion of investigational protocols was extended to national
groups in the early 90s. These include protocols from e.g. CRUK, MRC, SCTN and SIOP from the
UK, NKB from the Netherlands, SAKK from Switzerland, the German Cancer Society, FNCLCC from
France, and from other national groups. The NCI Liaison office actively seeks new European groups
with an interest to submit their research protocols to PDQ.
The PDQ database may be accessed via http://www.cancer.gov.
NCI Liaison Office and the International Network For Cancer Research and Treatment (INCTR)
Recently, the collaboration has been extended to closer interactions with the International Network for Cancer Research and Treatment (INCTR), a unique organisation dedicated to helping patients in developing countries, which is also located in Brussels and partially supported by the NCI’s Office of International Affairs. The NCI Liaison Office currently assists with some of the training and education activities.
Telesynergy® Medical Consultation Workstation
The NCI Liaison Office is the European hub for NCI’s TELESYNERGY® Medical Consultation WorkStation, installed in March 2004. The Telesynergy® Workstation allows numerous research collaborators at greatly separated geographic sites to interact as if they were in the same room, viewing the same medical images. By integrating powerful telecommunications technology into healthcare research and delivery, telemedicine enables clinical researchers to simultaneously communicate and view and manipulate data necessary for collaborations, including patient diagnosis and care, such as x-ray films and pathology samples. The telemedicine system has high quality, multisite teleconferencing capabilities, and is also capable of transmitting most types of diagnostic-quality medical images and information from several different sources, such as a microscope, a patient examination camera, document camera, color video printer, DVD player/recorder, and PC applications.
By making the knowledge and experience of oncology experts accessible regardless of where in
the world those experts are, TELESYNERGY® has the potential to dramatically accelerate cancer
research and improve cancer care by facilitating unique collaborations and connections.
Note:
The TELESYNERGY® Workstation is available at very low cost to outside collaborators.
Interested parties are welcome to use it.
For further information please feel free to contact the NCI Liaison Office: |