Academic clinical research will grind to a halt under the bureaucratic burden proposed by the EU, according to Jaap Verweij, professor of medical oncology at the Erasmus Medical Center in Rotterdam.
He said that international collaborations on clinical trials were vital for translating the results of laboratory research quickly into benefits for patients. Yet the EU's plans could make such collaborations difficult, if not impossible, thereby stifling important research and condemning many patients to death or years of suffering because they would be unable to benefit from new and better treatments for their cancers.
The discovery of a new and effective treatment for a rare and difficult-to-treat cancer has highlighted the way international collaboration can be translated into benefits for patients in a short time-scale that would be impossible if the research had to be carried out in only one country, said Prof Verweij.
"Sarcomas are a very rare collection of cancers of connective tissues such as bone, muscle, cartilage, fibrous tissue and blood vessels," explained Prof Verweij. "They represent only one per cent of all cancers. One of these is gastrointestinal stromal tumour (GIST), which arises from the connective tissue of the gastrointestinal tract. This is a very difficult cancer to treat successfully and for those patients who cannot be treated by surgery, the prognosis is poor, with an average survival of only one year.
"Recently, scientists recognised that it might be possible to control the disease by inhibiting the c-Kit gene, mutations in which were thought to control GIST. They found that the drug imatinib[2] did inhibit the gene and in a very short time phase I, II and III clinical trials have been performed, showing that imatinib is indeed a very active drug in GIST. Although further data are still needed, it is clear from these studies that median survival of patients with GIST has been increased by treatment with imatinib and that symptomatic benefit will be obtained with little toxicity in more than three-quarters of the patients with surgically unresectable, metastatic and advanced GISTs. A quite dramatic effect has been described in some of the patients. Further research is on-going to establish the best dose amounts for patients.
"The speed with which this discovery moved from the bench to the bedside would not have been possible without international collaboration. Due to its rarity, it was vital that GIST patients from around the world were included in the clinical trials in order to get enough of them to test the drug effectively. The fact that the collaborations stimulated by the EORTC[3] and the CTOS (Connective Tissue Oncology Society) enabled us to do two parallel phase III studies including over 1,600 patients in less than one year is a small miracle in itself! The studies involved all co-operative study groups in the USA, the EORTC, the ISG (Italian Sarcoma Group) and the AGITG (Austral-Asian Gastrointestinal Tumour Group), and were a typical example of collaborative academic clinical research at its best.
"However, the proposed EU directive on clinical trials puts this kind of collaboration into jeopardy. We definitely need these studies. Without them, progress will be delayed. The EU rules must move into line with reality and feasibility. If these problems are not solved, academic clinical research will come to a standstill and global collaboration will cease. We will have only pharmaceutical industry-sponsored research left, and although this is very good research, it stops at the moment a drug is registered, while the true value and role of a new drug is usually determined in academic clinical research."
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Notes
[1] The EU directive demands extra data collection, form-filling and inspections for even the most basic clinical trial, making trials more complex, expensive and difficult to set up and run. The provisions of the directive have to be adopted by 1 May 2004.
[2] Imatinib has the brand name of Glivec.
[3] EORTC – European Organisation for Research and Treatment of Cancer.
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