Quality Management Model for Phase I Clinical Drug Trials: A Structural Equation Model.

Current Medical Science
Yang ZhaoXin-Ping Zhang

Abstract

This study aimed to construct a quality management model for phase I clinical drug trials. A cross-sectional survey was conducted and data were collected from 604 respondents at 69 institutions in China engaged in phase I clinical drug trials. Exploratory and confirmatory factor analyses were used to develop the survey tool. Structural equation modeling was used to construct a quality management model for phase I clinical drug trials. The results showed that the final survey tool had good reliability and validity (Cronbach's α=0.938, root mean square error of approximation=0.074, comparative fit index=0.962, and Tucker-Lewis index=0.955). The model included five dimensions: government regulation, industry management, medical institution management, research team management, and contract research organization (CRO) management. In total, 22 measurement items were obtained. The structural equation model indicated government regulation, industry management, medical institution management, and CRO management significantly affected the quality of phase I clinical drug trials (β=0.195, β=0.331, β=0.279, and β=-0.267, respectively; P<0.05). Research team management had no effect on the quality of trials (β=0.041, P=0.610). In conclusio...Continue Reading

References

Jan 1, 1996·International Journal of Technology Assessment in Health Care·D MoherP Tugwell
Jul 5, 2001·Journal of Clinical Epidemiology·A P VerhagenP A van den Brandt
Aug 2, 2006·Journal of Clinical Nursing·Cheryl Rabin, Nili Tabak
Sep 20, 2006·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Manish AgrawalEzekiel J Emanuel
Oct 5, 2007·The New England Journal of Medicine·Miriam Shuchman
Mar 19, 2008·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Elizabeth L StrevelLillian L Siu
Apr 2, 2008·Medical Decision Making : an International Journal of the Society for Medical Decision Making·Kevin P WeinfurtNeal J Meropol
Nov 26, 2008·Clinical Trials : Journal of the Society for Clinical Trials·Kevin P Weinfurt
Nov 26, 2008·Clinical Trials : Journal of the Society for Clinical Trials·Nancy E Kass
Apr 24, 2009·Journal of Empirical Research on Human Research Ethics : JERHRE·Nancy KassHerbert Hurwitz
Apr 3, 2010·Urologic Nursing·Rebecca Deal Poston, Christine R Buescher
Feb 9, 2012·Nursing Forum·Christina Catania
Mar 2, 2012·Journal of Empirical Research on Human Research Ethics : JERHRE·Bailu WangXiaoyang Chen
Apr 9, 2014·Journal of Huazhong University of Science and Technology. Medical Sciences = Hua Zhong Ke Ji Da Xue Xue Bao. Yi Xue Ying De Wen Ban = Huazhong Keji Daxue Xuebao. Yixue Yingdewen Ban·Yu-Hong ShenLi-Jun Wang
Jan 17, 2015·Oral Oncology·Robert I HaddadJan B Vermorken
Jan 1, 2017·Studies in History and Philosophy of Biological and Biomedical Sciences·Maël Lemoine
Feb 2, 2018·Applied Clinical Informatics·Lauren HoustonAllison Martin
Jun 5, 2018·Experimental and Clinical Psychopharmacology·Julia RhekerAlexander Winkler
Mar 1, 2013·Therapeutic Innovation & Regulatory Science·Kenneth SprengerBriggs W Morrison

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