European journal of cancer : official journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)
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In 1977, Zelen proposed a new design for clinical trials with the aim of increasing recruitment by avoiding some of the problems associated with obtaining informed consent. These 'randomised consent' designs have proved controversial, and have not often been used. ⋯ All identified published cancer treatment trials using a randomised consent design are considered in some detail. Reasons for and against the use of these designs are summarised.
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The results of many clinical trials on empirical therapy in febrile, neutropenic cancer patients cannot be readily transferred to the clinical practice, because the methodology is often flawed and definitions, study endpoints and eligibility criteria differ from trial to trial. This article critically reviews some issues related to the design and implementation of randomised clinical trials of empirical antibiotic therapy in cancer patients. Within the definition of phase III clinical trials, two approaches co-exist, based on the trial's specific aims: the "explanatory" approach and the "pragmatic" approach. ⋯ Information related to fever and signs of infection, age, underlying disease, neutropenia and concomitant administration of other antibiotics are crucial entry criteria that need to be clearly discussed and defined. Finally, the evaluation of toxicity is problematic in this patient population, due to the existence of a number of toxigenic factors, including the underlying disease, the type of infectious complication, the administration of chemotherapy and radiotherapy and the use of parental nutrition. All these effects tend to overlap, thus impairing the investigator's ability to detect specific drug-related side-effects.