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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2014, Vol. 19 ›› Issue (1): 33-37.

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Impact of clinical pharmacists on protocol deviation in anti-cancer drug clinical trial

SHAN Jiao-jiao1,TANG Yi-qun1,SHI Mei-qi2, XIA Guo-hao2, WANG Li2,FANG Ying2,ZHAO Jie1   

  1. 1Clinical Pharmacy Teaching and Research Section,China Pharmaceutical University,Nanjing 210009,Jiangsu,China;
    2Department of Medical Oncology, Jiangsu Cancer Hospital,Nanjing 210009,Jiangsu,China
  • Received:2013-03-19 Revised:2014-01-17 Online:2014-01-27 Published:2014-02-12

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

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