Abstract:Objective The configuration of anti-tumor drugs in clinical trials is different from that of ordinary drugs. In recent years, there have been more and more clinical trials of new anti-tumor drugs, and the management of the configuration of anti-tumor drugs during the trial process has become increasingly important. This article mainly explores the role of GCP pharmacists in drug configuration management in phase II and III anti-tumor clinical trials, in order to provide experience reference for peers. Methods Review the preparation of anti-tumor drugs in phase II and III clinical trials of our hospital from January 2023 to November 2023, and summarize the positive effects of GCP pharmacists participating in phase II and III clinical trials. Results All ongoing clinical trial configuration work in the first 11 months of 2023 showed that: ① 4464 bags of clinical trial drugs were dispensed without any incidents of medication delay caused by dispensing errors; ② GCP Pharmacists intercepted a total of 19 times, mainly involving errors in drug dosage and non-standard preparation forms; ③ A total of 314 adverse reactions occurred with anti-tumor drugs, including 83 grade III and IV adverse events. The most frequent adverse reactions were mainly ophthalmic toxicity, decreased neutrophil count, decreased platelet count, and decreased white blood cell count. The drugs involved mainly included antibody conjugated drugs, paclitaxel, cisplatin, etc.; ④ GCP pharmacists continuously optimize workflow, develop relevant SOPs, and standardize configuration forms. Conclusion GCP pharmacists participate in the management of infusion configuration in clinical trials of anti-tumor drugs, playing a positive role in various aspects such as scheme review, standardized drug configuration, personnel protection, and adverse reaction monitoring. At the same time, they greatly improve the efficiency of configuration, effectively ensure infusion quality, and ensure the safety of clinical trials of anti-tumor drugs.