Brief introduction to phase I clinical trial subjects management

Welcome to Chinese Journal of Clinical Pharmacology and Therapeutics,Today is Chinese

Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2014, Vol. 19 ›› Issue (3): 320-322.

Previous Articles Next Articles

Brief introduction to phase I clinical trial subjects management

HUANG Ping¹, ZUO Rong¹, XIA Chun-hua², XIONG Yu-qing²

¹State Drug Clinical Trial Agency,the First Affiliated Hospital of Nanchang University,Nanchang 330006,Jiangxi,China;
²Institute of Clinical Pharmacology,Nanchang University,Nanchang 330006,Jiangxi,China

Received:2014-02-25 Revised:2014-03-10 Online:2014-03-26 Published:2014-04-10

Abstract

Abstract: Discuss subject recruitment and compliance management in the process of the phase I clinical trial. Analysis the difficulties in recruiting subjects and take effective measures to improve recruitment efficiency and subject compliance. In the whole process of trial, improving subject compliance depends mainly on researchers' sincere care, respect, kindness and solid knowledge of medical skill.

Key words: phase I clinical trial, subject, recruitment, compliance

CLC Number:

R969

HUANG Ping, ZUO Rong, XIA Chun-hua, XIONG Yu-qing. Brief introduction to phase I clinical trial subjects management[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2014, 19(3): 320-322.

[1]	LIU Min, KONG Xiang, ZHANG Ye, GU Yifei, XIANG Xuemei, HE Qing, HUANG Kai. Analysis of reasons for screening failure of healthy subjects in clinical trials of orally inhaled drug products [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2023, 28(7): 758-766.
[2]	LIU Min, KONG Xiang, ZHANG Ye, GU Yifei, XIANG Xuemei, HUANG Kai. Safety analysis on bioequivalence studies of orally inhaled drug products in healthy Chinese subjects#br# [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2023, 28(10): 1131-1138.
[3]	SONG Yan, GAO Linyan, ZHANG Yanping, LI Xiang, ZHANG Lan. Application of medical failure mode and effect analysis in blood sample management in phase I clinical trials#br# [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2021, 26(9): 1031-1036.
[4]	ZHONG Zihang, CHEN Feng, YUAN Ying, CHENG Jiancheng, YU Xuanxuan, YANG Min, TAN Mingmin, ZHAO Yang, BAI Jianling, YU Hao. A novel model-assisted design in phase I clinical trials: Bayesian optimal interval design [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2020, 25(6): 640-648.
[5]	ZHANG Zhengfu, LI Meng, WANG Jianan. Protection of subjects' legal rights, welfare and safety in clinical trials of COVID-19 [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2020, 25(4): 421-425.
[6]	Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, GCP Center Phase I Clinical Trial Ward, Shenyang , Liaonning, China. Bioequivalence of rosuvastatin calcium tablets in Chinese healthy subjects [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2020, 25(12): 1369-1375.
[7]	YANG Haijing, YU Jicheng, WANG Jingjing, LI Nanyang, WU Jufang, ZHANG Hai, XUE Tao, DAI Weiguo, DING Tianling, CAO Guoying. Risk management of biological agents in phase I clinical trials: Case sharing [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2020, 25(1): 44-48.
[8]	LI Jingjing, YU Yanxia, TANG Lian, ZHANG Jinkun, YU Qiang, SHANG Erning. Influence of clinical pharmaceutical care on medication compliance and treatment effect in Helicobacter pylori positive peptic ulcer outpatients [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2018, 23(2): 199-204.
[9]	CAO Bei, GENG Yan, LI Juan. Brief probe into the application of BEIS system of ECRFPlus in Phase I clinical trials [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2018, 23(12): 1431-1437.
[10]	YE Yujie, YUAN Weian, HE Min. Implementation points of the urine sample collection in phase I clinical trial of drugs [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2018, 23(12): 1438-1440.
[11]	LI Xiu, JI Zhaoning. Chemotherapy compliance of patients with digestive system cancer and its influencing factors [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2017, 22(5): 565-569.
[12]	LI Guo-zhu, XIE Hai-tang, CHEN Bai-feng, WANG Hao, SUN Xiao-tian. A survey on adult medication compliance and its influencing factors analysis [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2015, 20(1): 47-50.
[13]	HANG Rong-hua, LI Ye-ping, WU Ming-fei, LI Rui. Relationship on medication compliance, antipsychotic side-effects and social support in schizophrenia outpatients [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2014, 19(8): 912-915.
[14]	SHAN Jiao-jiao,TANG Yi-qun,SHI Mei-qi, XIA Guo-hao, WANG Li,FANG Ying,ZHAO Jie. Impact of clinical pharmacists on protocol deviation in anti-cancer drug clinical trial [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2014, 19(1): 33-37.
[15]	ZHANG Zheng-fu, SHEN Yu-hong, LI Zheng-qi. Problems in the recruitment and management of trial subjects for phase I clinical trials in China [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2012, 17(5): 481-484.

Brief introduction to phase I clinical trial subjects management

PDF (PC)

Knowledge

Abstract

Cite this article

share this article

References

Related Articles 15

Recommended Articles

Metrics

Comments