Drugs under experimental and clinical research
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Considerable progress has been made in the treatment of cancer. However, there is still a need for new drug development. The preclinical antitumour activity of new anticancer agents is evaluated by sequential testing in murine tumours and human xenografts in mice. ⋯ Further dose increases depend on the type and severity of these toxic side-effects. Patients included in phase I clinical trials of anticancer agents must have histologically proven malignant disease that cannot be treated by conventional therapeutic modalities. They should have normal haematological, renal and hepatic functions and should be expected to live long enough to evaluate properly the toxic effects of the new compounds.(ABSTRACT TRUNCATED AT 250 WORDS)
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Controlled clinical trials, usually carried out in a multicentre, randomized manner, have become fashionable and popular because they contribute to the general acceptance of the results, particularly when the difference between the treatment arms is small. The present book and the present introduction attempt to discuss when and how this form of trial is appropriate. It is recognized that the discussion may be one-sided in the sense that the undoubted and well-known merits of controlled clinical trials are not reiterated. ⋯ The number of patients subjected to phase II trials can be appreciably reduced if reasonable statistical measures are taken, as proposed here, to optimize and minimize the trial. Phase III trials must improve the relevance of the questions asked, reporting of errors, patient information and statistical interpretation. They must be based on promising phase II studies with historical controls so that their efficacy is increased.