Improving Stem Cell Clinical Trial Design and Conduct: Development of a Quality Assessment Tool for Stem Cell Clinical Trials

Table 2

Validation of quality assessment tool of stem cell clinical trials by structural equation modeling.

Quality attribute	Quality indicator	Estimate	Factor load	SE	value	value
Participant protection	Risk management and AE/SAE reporting plan	1.000	1.000
Scientific value	Clinical significance of the research question	1.000	0.545
	Research design	4.095	0.558	1.737	2.357	0.018
Quality control	Staffs/committees and definition of the roles	1.000	0.902
	Data integrity	0.885	0.645	0.22	4.018	<0.001
	Implementation quality control strategy	1.904	0.759	0.398	4.781	<0.001
Stem cell products	Material harvest standards and SOPs	1.000	0.543
	Stem cell production standards and SOPs	0.813	0.725	0.297	2.741	0.006
	Product logistic and management plan	0.854	0.676	0.32	2.67	0.008
Overall quality
	Participant protection	1.000	0.760
	Scientific value	0.172	0.953	0.064	2.716	0.007
	Control strategy	0.515	0.729	0.151	3.418	0.001
	Stem cell products	0.760	0.826	0.301	2.53	0.011

SE: standard error; SOP: standard operation procedure; value < 0.05.