UICC World Cancer Congress 2006

Alexander M.M. Eggermont, MD, PhD

Translational Research is the Driver

Clinical research has gone from observational to science-driven. This makes clinical research not only better and much more interesting, but also more complex and more costly. There is a global need to facilitate, to learn, teach and apply translational research as mandatory components into clinical research to assure that we learn from both negative and positive trials. In Europe the need for new translational research initiatives to place European oncologists at centre stage in drug development and clinical cancer research in general is a task that the EORTC (European Organization for Research and Treatment of Cancer) is taking seriously.

Academic Trials

The EORTC was founded in 1962 to conduct, co ordinate, and stimulate research in Europe to improve the management of cancer through the multidisciplinary, multinational efforts of basic research scientists and clinicians, to facilitate the passage of experimental discoveries into state-of-the-art treatment and aims to minimise the delay between the discovery of new anti-cancer drugs and their therapeutic benefit for patients. Around 100 clinical trials are running at present, involving some 35,000 patients.The Data Centre at EORTC headquarters in Brussels, with around 120 staff, offers important support functions, such as data management, statistical design and analysis, quality of life assessment, regulatory affairs, and quality assurance and clinical cancer methodology research . A major component of the EORTC program consists of non-sponsored academic trials regarding surgical methods, radiotherapy regimes, and systemic therapy combinations to define new standards of care, studies for which it is not easy to get pharmaceutical sponsorship as they may involve combinations of drugs that may have been registered for several years. Yet such studies are vital to define new standards of care and the EORTC is committed to perform them.

Drug Development Trials

Apart from academic trials is the EORTC involved in fully sponsored drug development trials, including pivotal phase III trial for geistration of new drugs. For this EORTC developed flexible mechanisms where the monitoring and part of datalistings is out sourced to contractors, but the hard core scientific evaluation and quality assurance is undertaken EORTC. It is ironic that EORTC receives a core grant from the National Cancer Institute (NCI); but not from Brussels. It reflects a lack of awareness of scientific issues among the European population and their politicians.

Increasing Regulatory Complexicity

The EU-directives on the conduct of clinical research has increased the costs of academic trials by a factor 2-3. Moreover it has made clinical trials more time consuming to organize and made it hard to recruit clinicians who are aware of the extra time it eats up. At the institution level across Europe a 50 % reduction in the number of clinical trials hs been observed initially, but activity seems to be picking up now that people are getting used to the new rules .

How to improve Translational Research: EORTC-NOCI: Network of Core Institutes

To realize top quality both in trial design and trial conduct, top logistics for collection of tissues, creation of real as well as virtual tumor banks, engagement of top laboratories as well as top clinical institutes are a prerequisite these days. To this end the EORTC has launched a network of core institutes (NOCI) that represent academic clinical and research instutions that offer both good accruing power into clinical trials as well as the necessary infrastructure, both at the clinical research level as on the basic science / translational research level to allocate the translational research projects that are generic to EORTC trials, in particular the drug-development trials.

Taking it to the public and to the politicians

Europe - with its population of 500 million - has a tremendous opportunity to take the international lead in drug development. But the problem we face is that European society doesn't have the same belief and awareness of science as for instance in the USA. We need to create patient platforms, as in the US, to push for first rate-scientific clinical trials and persuade politicians to give a greater weighting to funding.