Antiemetic study methodology: recommendations for future studies.
The methodology of future antiemetic studies will reflect the need to address the problems identified in current studies. New preclinical information on the mechanisms of emesis and antiemetic action will allow more rational clinical study design. Prior to large randomized studies, phase I and II trials should define the minimum effective dose of an antiemetic which may differ according to the strength of the emetic stimulus. The most convenient route of administration and schedule should also be sought in early phase trials. New endpoints such as cost-effectiveness should be incorporated into phase III studies, which should also serve as vehicles for further studies of prognostic factors. Problem areas such as delayed emesis should be specifically targeted in future trials. Patients must evaluate the overall benefit of a new antiemetic regimen.
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Medical Oncology, Royal Adelaide Hospital, S.A., Australia.
D000818:Animals; D000932:Antiemetics / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods*; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D005544:Forecasting; D006801:Humans; D012702:Serotonin Antagonists / Q000627:therapeutic use*
D000932:Antiemetics; D012702:Serotonin Antagonists