METHODOLOGICAL ISSUES IN ANTIEMETIC STUDIES

In summary, the clinical application of the 5-HT3 antagonists presents new opportunities for the control of the nausea and vomiting associated with cytostatic therapy. If these agents are to be employed at optimal efficacy, both as single agents and in combination, adequately defined doses and schedules (from phase I-II studies) should be investigated in double-blind, randomized and appropriately stratified phase III trials. This is dictated particularly by the subjective nature of nausea and the multi-factorial etiology of nausea and vomiting. Efficacy should be judged according to agreed response criteria for which there is currently no consensus. Response criteria should be based on the patient's experience of both nausea and vomiting, if these are to adequately relate to the patients experience and improve their tolerance of emetogenic therapies. Finally, emphasis should be given to the results after the first 24 hr of acute control of examine the delayed phase, and to assess the results over several cycles of treatment. There is also a lack of data studying the control of anticipatory nausea and vomiting, and new, well designed studies using all the factors described above need to be constructed in these important settings. © 1993 Kluwer Academic Publishers.