Abstract: AIM: To explore the impact of clinical pharmacists on the occurrence of protocol deviation in antineoplastic drug clinical trial.METHODS: Subjects between September 2011 and May 2012 were enrolled in non-intervention group,while intervention group included subjects between June 2012 and February 2013 with pharmaceutical intervention. The incidence of protocol deviation was analyzed and the effects of pharmaceutical intervention were observed.RESULTS: 61.3% cases in non-intervention group occurred protocol deviation including 37.3% major protocol deviation,in contrast, 43.9% cases had protocol deviation including 19.7% major protocol deviation in intervention group. Protocol deviation (P<0.05) and major protocol deviation (P<0.05) were significantly lower in intervention group.CONCLUSION: Clinical pharmacists could effectively reduce protocol deviation in antineoplastic drug clinical trials. Being a part of clinical trials provides clinical pharmacist a new opportunity to work at the department of medical oncology.

Key words: Clinical research protocol, Research subject, Clinical pharmacist, Protocol deviation