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image European Research News Centre > Medicine and Health > Because clinical research is fundamental
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image image image Date published : 03/04/2002
  image Cancer
Because clinical research is fundamental

 

RTD info 33

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Because clinical research is fundamental
With 2 500 voluntary practitioners in some 360 hospitals, the European Organisation for Research and Treatment of Cancer (EORTC) is a major spearhead in the global fight against cancer. By organising rigorous clinical trials on a vast scale it has permitted major progress in the treatment of the most varied forms of the disease.
   
     
   

The EORTC was set up 40 years ago by a handful of pioneering doctors working on a voluntary basis. It is not only one of the oldest experiences in creating a European research area but also one of the most successful. 'At first it was no more than a meeting of a select group of eminent and visionary oncologists without any mandate,' stresses Françoise Meunier, the organisation's director general. 'But given the urgency of the fight against cancer they were aware that one country alone would never be able to cope and that it was crucial to make the most of the potential offered by European coordination of clinical research.'

Survival and quality of life

What is EORTC's mission? To improve the treatment of cancer, by helping to develop new drugs as well as by defining optimal therapeutic strategies (surgery, radiotherapy and chemotherapy) and the best possible use of existing methods. Epidemiology and prevention - although also vital - are not within its scope: its chief task is to develop not just more effective treatment in terms of patient survival but also treatment which is able to improve their quality of life.

The network develops and implements rigorous clinical trials on vast numbers of patients throughout Europe. It is particularly necessary to have a wide field of experimentation for cancer - as combating it requires a mix of treatments based on a multidisciplinary approach, unlike AIDS, diabetes or hypertension, for example, which are usually treated by drugs alone. In oncology, a new treatment can lead to questions about the optimal way to administer it and, when it is approved by the authorities, about how it would ineract with other treatments. The process of clinical research is therefore crucial for implementing the results obtained in the laboratory and on animals.

With or without industry

To develop new medicines, it is very often necessary to work closely together with the pharmaceutical industry, which looks to the EORTC network to develop clinical trial strategies for innovative treatments and to test them at European level. The institution offers its formidable know-how while retaining its independence in terms of analysing the data and guaranteeing the validity of the results.

The development of reference treatments also involves carrying out a large number of tests which do not necessarily involve industry, and which could at times be contrary to its interests. As Françoise Meunier stresses: 'Drug manufacturers do not need to know, for example, whether a total or partial removal of the breast is preferable, whether radiation or surgery is best for prostrate cancer, or if a course of chemotherapy is best over four or six cycles. It is only so-called academic - in the sense of non-commercial - clinical research which can answer these questions of therapeutic strategy. Around 70% of clinical trials carried out by the EORTC are without industry partnerships. That is why it is essential to continue funding this multidisciplinary clinical approach in Europe, carried out totally independently and most often on a voluntary basis.'

A complex and painstaking approach

How is a clinical trial conducted? One may want to determine, for example, whether or not it is useful to follow irradiation of a prostrate cancer with a course of hormone therapy. A trial of this kind,(1) conducted in three distinct stages (see box), involves recruiting a large number of patients - sometimes several thousand - while respecting information and transparency requirements as well as international standards and national laws. Some are treated by the conventional means used to date and others by experimental treatment. The two groups (selected by a procedure known as randomisation) are carefully monitored to compare the results in terms of toxicity, survival and quality of life.

Many difficulties must be overcome. An experienced and international network with a sufficient 'critical mass' to identify therapeutic improvements - even if for just a few percent of the cases treated - is vitally important.

Ideally, several countries should participate in stage three to reduce the influence of local bias and recruit patients within a reasonable time frame. But the data must also remain homogeneous and the technical content and quality assurance procedures must be of the highest standard.

Finally, any legal problems posed by the existence of different national legislation and ethical committees need overcoming. 'For the same trial, seven different insurance policies must be taken out (with different premiums) due to the lack of harmonisation of the legal obligations in different countries. The trial is sometimes finished before the legal problems concerning a country's participation have been sorted out. This evident drawback effects European innovation and competitiveness in treating cancer.' (2)

The 'translational' approach

It is sometimes difficult to persuade doctors to participate in clinical trials as respecting protocols can be very time consuming. 'For an individual cancer specialist working at a hospital it is often easier not to take part. An investigator has to spend more time with the patient, explaining to him all matters concerning the treatment of his illness, obtaining consent, setting up a team to carry out the trial, collecting and communicating the data, and sorting out legal and insurance matters to get the necessary approval to proceed.'

Fewer than 5% of cancer specialists currently take part in clinical trials, approximately the same percentage as for cancer patients - despite the fact that treatment in a research context (whether or not you are in the group receiving experimental treatment) can mean closer care, more rigorous treatment, an improved quality of life and better survival prospects.

The fact is clinical research does not enjoy the same prestige as fundamental research. 'The researcher who discovers a new molecule is much more fêted than the researcher who discovers in what doses and in what circumstances it must be administered. The institutions which finance health care (social security, mutual associations, insurance companies, etc.) are also reluctant to support clinical research, despite the fact that it can improve the management of health care systems, for example by reducing redundant or obsolete treatment, or by enabling a more efficient allocation of resources.'

Fortunately, the fundamental/clinical divide is now closing and the move 'from mice to men' is attracting growing interest among decision-makers and the authorities. Removing this barrier is moreover the principle behind 'translational research' which is developing rapidly due to recent progress in molecular biology and genomics. This approach involves bringing together specialists to cooperate at every stage of the process - from the test tube to the hospital bed - while ensuring a two-way information flow: from the fundamental to the applied and from the applied to the fundamental, thereby creating a synergy effect.

A genuine 'clinical bank'

This is the spirit which inspires EORTC. Once the trial results are obtained, the organisation seeks to disseminate them in a way which enables members of the medical profession in Europe and elsewhere to be continuously informed of the latest discoveries and the most promising strategies. It does so through scientific publications, conferences and courses. EORTC's analysis centre in Brussels also maintains a database on more than 130 000 patients who have taken part in clinical trials over the past 40 years. Every year, an additional 7 000 files are added to this data centre which many researchers consult regularly. ' EORTC is working on a project to compile a pan-European tumour bank with samples of tissue taken from cancer patients included in clinical trials,' explains Ms Meunier. 'The purpose is for researchers to be able to re-evaluate the tissue samples if one day new markers are discovered or new tests developed which make it possible to refine treatment and validate certain hypotheses by possible correlation with the patients' clinical data.'

Correlation between lung cancer,
smoking and the genes

Correlation between lung cancer, smoking and the genes

There is no longer any doubt about the causal link between smoking and lung cancer. However, smoking-related cancers could be influenced by genetic factors which affect the metabolism of the tobacco carcinogens. Some genes which code the enzymes involved in this metabolism could affect the cancer risk.

(Study of the action of the CYP2D6 cytochrome in 130 cases and 170 control cases) © S. Benamou, INSERM

(1) About 100 clinical trials of this kind are permanently under way under the aegis of the EORTC.
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(2) All quotations are by Françoise Meunier.
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EORTC, a multidisciplinary platform

Much progress has been made over the past 40 years. Today, EORTC is a unique European institution, also recognised by the prestigious US National Cancer Institute (NCI) which, since 1974, has co-financed the analysis centre, home to its only office outside the United States. In addition to 'translational' and applied research, the organisation works with the computerised management of clinical data, quality of life, and the economic value of therapies, statistics and methodology.

And in the past decade, the headquarters has increased its personnel from 28 to 134, including 100 university graduates. EORTC has its own foundation (Queen Silvia of Sweden is its president) and receives financial backing from most of the European national leagues against cancer as well as the European Commission (for specific research projects), private donors and the pharmaceutical industry (to evaluate new drugs). Its network of 2 500 members includes surgeons, oncologists, radiotherapists, immunologists and specialists from other disciplines. They all provide their services free of charge.

Françoise Meunier - EORTC director-general for the past 10 years.

Françoise Meunier
EORTC director-general for the past 10 years.

 

2002, Europe against cancer meeting

On the occasion of its 40th anniversary, EORTC is holding a 'Scientific Strategy Meeting' in Brussels from 26 to 28 March 2002. The meeting will look at the current state of cancer research and seek to lay the foundations for future developments in clinical research by EORTC.

To find out more

http://www.eortc.be/
EORTC Communications Officer
Samantha Christey
sch@eortc.be

 

The three obligatory stages in a clinical trial

Stage I - A new experimental treatment - previously tested in a laboratory on cell cultures and animals - is tried out on a small number of patients (between 10 and 40). Doctors seek the best way of administering it, in complete safety for the subject, and determine the maximum tolerated dose.

Stage II - The trials, generally including between 40 and 80 patients, assess the effectiveness of the experimental treatment tested on different types of cancer.

Stage III - If a stage II trial has shown that a treatment has an anti-cancer effect, the conventional or standard treatment (the one most commonly applied in a given pathological situation) is then compared with an innovative treatment which it is hoped will prove more effective and/or less toxic.

 

Clinical trials and ethics

EORTC respects the ethical rules laid down in the Helsinki Declaration, drawn up by the World Medical Association. This fundamental text is a moral charter whose objective is to provide recommendations for doctors and others involved in medical research on human beings. It also includes studies carried out on personal data or non-anonymous biological samples.

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The patients speak

Although progress in research is often discussed in terms of 'cancer survival', EORTC has always been interested in a vital human aspect: the quality of life of patients. Some treatments or strategies improve patient comfort a great deal, even if they have no effect on the cancer's development. The evaluation of quality of life is based, in particular, on 'validated articles'. In-depth questionnaires - with a common section for all patients and another which is specific to a particular cancer type - are available in 42 languages and enable patients to express how they feel before, during and after the trial. These documents are valuable instruments developed by the organisation and are available to practitioners and researchers.

 


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