There are currently 22.4 million people in the world living with cancer. It accounts for over one in eight of all deaths. In Europe, cancer remains the second cause of mortality after cardiovascular diseases. On average 2.7 million new cases are diagnosed every year and 1.7 million of the population of Europe die from it.
Globally, the incidence of cancer is rising due to several factors, including an ageing population and unhealthy lifestyles, such as smoking. Today, about 50% of patients are cured, so there is still a long way to go to improve cancer care.
HIGH-QUALITY CLINICAL RESEARCH
The tremendous advances in knowledge of the epidemiology, genetics and molecular biology of cancer make us confident that in this century appropriate strategies will be established for most cancers.
In the short term, intelligent application of existing knowledge and implementation of state-of-the-art treatments for all patients should greatly improve cancer care and patients’ survival. There have been major breakthroughs in our understanding of cancer and there are currently many new potential treatments waiting to be tested and validated, bringing greater hope than ever. Comprehensive cancer research programmes are essential to achieve these goals.
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Clinical research into cancer is looking to develop innovative, more effective and less toxic treatments. Cancer clinical trials are complex, as these studies are conducted with patients with life threatening diseases.
The art and science of high-quality clinical trials is not only demanding and expensive but also highly dependent on good operational design, including statistical analysis, rigorous quality assurance programmes, effective computer technology and, most importantly, medical knowledge.
Multinational and multidisciplinary approaches of already established networks in Europe are at a great advantage, allowing for complex therapies to be evaluated, even in cases of rare cancers. In addition, large-scale trials involving thousands of patients with common diseases will demonstrate small but medically important differences that can benefit many patients.
More specifically, high-quality clinical trials are aiming either at developing and registering new agents (which are either less toxic or more effective) or at establishing state-of-the-art treatments using drugs which are already on the market and used in combination with other therapeutic modalities such as surgery or radiation therapy. This second category of trials is usually conducted by academic research networks supported by cancer charities and foundations.
There are numerous examples of successful non-sponsored studies leading to change of practice, such as larynx preservation in case of head and neck cancer, conservative treatment in case of breast cancer and the role of adjuvant therapy for brain tumours, amongst others. However, both types of trials need to be evaluated on an independent basis.
All clinical trials have to be conducted according to international standards established by the International Conference of Harmonization (ICH), the Declaration of Helsinki and the national legal requirements according to the European Directives 2001/20/EC and 2005/28/EC. The European legal framework is under review following the implementation of the clinical trial directive 2001/20/EC.
FOLLOWING THE DIRECTIVE
This directive and the second directive on Good Clinical Practice (GCP) (which was the European Commission Directive 2005/28/EC of 8th April 2005, and laid down principles and detailed guidelines for good clinical practice with regard to investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products) raise a number of important problematic issues for academic research.
The guiding principle behind these directives is to promote and facilitate clinical trials in Europe while protecting the patients’ rights.
But unfortunately, the directives may lead to a profound and damaging effect in the key area of non-commercial research, which is essential in order to establish state-of-the-art treatments for all patients with cancer.
While most physicians acknowledge the importance of clinical research, less than 5% of medical doctors have participated in clinical trials. Similarly, less than 5% of cancer patients in Europe are currently enrolled in clinical trials as most patients in Europe are still unaware and uninformed of the potential benefits that are derived from their involvement.
Clinical research based on sound medical methodological and ethical grounds is fundamental to advances in high-cancer care and ultimately, to finding a cure for cancer.