1. The Clinical Study Of Anti-cancer Drug Clinical Trials And Data Management 2.The Antiarrhythmic Effect Of The New Compound CPUY102122

In the first part of this paper,by introducing a clinical trial which I participated in Jiangsu Cancer Hospital,I described the whole research procedure of anti-cancer drug clinical trials. Clinical trial data management(CDM) was involved to understand the popularization and application of Electronic data Capture(EDC) system in drug clinical trials.In part II,I discussed the antiarrhythmic effect of the new compound CPUY102122.PartⅠ. The clinical study of anti-cancer drug clinical trials and data managementIn PartⅠ, we discussed a Single arm, non-randomized, open, multi-center Phase ⅡTrial of Chidamide to introduce the whole research procedure of anti-cancer drug clinical trial and how I assisted the investigator in conducting the trial, including organizing and supervising the trial during the whole procedure as an intern study coordinator.Meanwhile,by introducing comprehensive pharmaceutical care to play the advantages of my professional to improve the quality of trials.During the whole procedure of over 3 year period trial, there are totally 15 sites and 83 enrolled subjects involved. Following Good Clinical Practice(GCP) and protocol tightly, the clinical trial was accomplished not only on time, but also got high quality clinical data. The result shows that original oral drug Chidamide has good effect with recurrent or refractory PTCL,and it’s main objective response rate is comparable with orphan drug’s Pralatrexate and Romidepsin.The Chidamide has better security,it’s main adverse reaction is the blood toxicity, so the Chidamide has good clinical value to improve the recurrent and refractory PTCL therapy.The clinical trial data management(Clinical data Management, CDM) is an important part in clinical research, throughout the entire clinical trials.From the following several aspects:the current situation of drug clinical trial Data management in China, Electronic Data Capture(Electronic Data Capture, EDC) system introduction, EDC system advantage, and EDC Data Query,we bring up the Electronic Data Capture(EDC)system,a good way to realize more quality and efficient completion of clinical trials.In order to provide references to Sponsor, investigator and CRA for their data collection and monitoring work and improve the quality of clinical trials,the study investigated the status of queries in clinical trials applying RDC Onsite Electronic Data Capture System.Data of all enrolled subjects from 5 completed clinical trials were collected. All the queries from CRA and Data Review Department were estimated and analyzed based on the type, frequency and resolution in different modules. The results showed in all the e CRF models, Trial completed、concomitant drugs and adverse event are main sources of queries;missing data is the most common type of queries.Characters of different e CRF model and frequency of kinds of queries provides a good reference to research institutes of having adopted and will adopt EDC system especially RDC Onsite system to capture data.In practice,by thinking about clinical trial stage,the particularity of tumor drug clinical trial implementation, the subjects’ rights and security,the compliance of subjects, the record of Case Report Form(Case Report Form, CRF) as well as quality control and quality assurance constantly,I had a comprehensive cognition about tumor drug clinical trials.Phase II. The antiarrhythmic effect of the new compound CPUY102122AIM: To observe the intervention of the CPUY102122 on the model of aconitine-induced arrhythmia. METHOD: After anesthetized with 20% urethane (2g/kg, i.p.), the rats were randomly divided into six groups: untreated group, CPUY11018(3mg/kg), Amiodarone(0.4mg/kg),CPUY102122 high dosage group(9mg/kg, i.p.), middle dosage group(3mg/kg, i.p.) and low dosage group(1mg/kg, i.p.). One hour after medication, the right jugular vein was cannulated with polyethylene tubing for injection of aconitine(0.2ml/min) at a constant speed(0.2ml/min) to make Arrhythmia models.The change of ECG, initial ventricular premature beat(VPB), ventricular tachycardia(VT), atrial fibrillation(AF), ventricular flutter, ventricular fibrillation(VF) and cardiac arrest(CA) were then recorded. RESULTS: CPUY102122 can delayed the time of ventricular flutter and VF of arrhythmic models of rats at a low dosage(P< 0.01); while the time of VPB, VT, AF, ventricular flutter, VF and CA can be delayed at a middle dosage group(P< 0.05 or P< 0.01); The high dosage group of CPUY102122 can delayed the time of VT, AF, ventricular flutter, VF and CA of arrhythmic models of rats(P<0.05 or P<0.01). CONCLUSION: The new compound CPUY102122 has some antiarrhythmic activity.