Professor Baum, chairman of the 3rd European Breast Cancer Conference, told a news briefing that the organising committee of the conference were unanimous in their concern. At the end of the conference tomorrow (Saturday 23 March) delegates will be asked to agree a policy which will culminate in a document – the Barcelona Declaration - to be presented to European Union health commissioners.
"These threats to research come from multiple directions – EU regulations on clinical trials, the revised Declaration of Helsinki, which is branding some legitimate clinical research unethical, and the activities of animal rights," said Professor Baum.
On top of this the increasing bureaucracy of informed consent procedures was frightening off both clinicians and patients. "It is also deterring young clinical researchers," he said. "They feel the game isn’t worth the candle."
The topic will be the subject of the final conference debate tomorrow. To set the scene for the delegates, Professor Baum has turned to George Orwell’s famous novel ‘1984’ for inspiration for a short satirical drama entitled ‘2084’, which will performed by the panellists. He envisages the hero of Orwell’s novel as a medical oncologist in the year 2084 whose attempts to carry out clinical research lead him into confrontation with the authorities and end with him being hauled before the Ministry of Truth and Health accused of the ultimate crime of not being politically correct.
Said Professor Baum: "It may be tongue in cheek but it makes an extremely serious point. If we care for the future of clinical research we must be prepared to challenge those rules and regulations that are gradually and insidiously undermining our ability to carry it out."
Dr Martine Piccart, head of the chemotherapy department at the Institut Jules Bordet in Brussels, told the briefing of her concern for the future of clinical trials.
She said that she belonged to the generation of physicians who joined the clinical research field at a time when a clinical trial could be initiated within one to two months.
"No wonder that this field catalysed my enthusiasm, given the much needed improvement in our anti-cancer strategies," she said. "But, as regulations in the field started to grow exponentially, resulting in a rapid multiplication of administrative procedures linked to trials, I probably developed ‘protective antibodies’, which helped me cope with this mounting bureaucracy."
She said her biggest fear was for the young generation of oncologists. She was finding it increasingly difficult to motivate young doctors for clinical research.
"It was time to ring an alarm bell, so I brought the issue to the organising committee of EBCC-3, who immediately endorsed the idea of devoting a whole session to the subject. Indeed, this conference offers a unique opportunity to raise awareness since it involves not only physicians, but also nurses, basic scientists, epidemiologists - and health care consumers through Europa Donna."
Dr Piccart said EBCC-3 was fortunate also to have a talented chairman who could put together a play, as there was nothing like humour to introduce a very serious topic.
She pledged that the rebellion against an increasing number of unnecessary, costly and time-consuming bureaucratic hurdles would not stop after the Barcelona meeting. "We will go forward and publish the highlights of the round table discussion, and Europa Donna, being sensitised to the problem, will most likely help us in lobbying the European Parliament in order to re-establish a healthy environment that facilitates clinical and translational research."
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