Summary
Progress in antiemetic research dictates that clinical trials of antiemetic agents be conducted according to guidelines for Good Clinical Practice, as follows. Studies must be of a prospective, parallel-group design in which the new treatment is compared with the existing best available treatment, after optimal dosage schedules for each have been established. Ethically, placebo-controlled trials can only be justified when chemotherapy with a low emetogenic potential is used. All end-points (nausea, vomiting, adverse events and quality of life parameters) must be specified in detail before the trial is begun. Patient populations must be homogenous with respect to prior chemotherapy and other confounding variables. Finally, patients must actively participate in the evaluation of antiemetic therapy, since only they can provide reliable information regarding the impact of nausea and vomiting on their quality of life.
Similar content being viewed by others
References
Gralla RJ, Itri LM, Pisko SE, Squillante AE, Kelsen DP, et al. Antiemetic efficacy of high-dose metoclopramide: randomized trials with placebo and chlorpromazine in patients with chemotherapy induced nausea and vomiting. New England Journal of Medicine 305: 905–909, 1981
Klein Poelhuis EH, Hart AAM, Burgers JMV, Hermus RJJ, Bruning PF. Assessment of quality of life: scoring performance status in cancer patients. In Aaronson NK, Beckman J (Eds) The quality of life in cancer patients, pp. 93–99, Raven Press, New York, 1987
Kris MG, Tyson LB, Gralla RJ, Clark RA, Allen JC, et al. Extrapyramidal reactions with high-dose metoclo-pramide. New England Journal of Medicine 309: 433–434, 1983
WHO handbook for reporting results of cancer treatment. World Health Organization, Geneva, 1979
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
McVie, J.G., de Bruijn, K.M. Methodology of Antiemetic Trials. Drugs 43 (Suppl 3), 1–5 (1992). https://doi.org/10.2165/00003495-199200433-00003
Published:
Issue Date:
DOI: https://doi.org/10.2165/00003495-199200433-00003