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

Table 3

Results from quality assessment tool for stem cell clinical trials by phases of trials.

Quality attribute	Quality indicator	All ()		Exploratory phase ()		Confirmatory phase^† ()
		Mean	SE^§	Mean	SE^§	Mean	SE^§
Participant protection	Risk management and AE/SAE reporting plan	0.362	0.185	0.373	0.190	0.322	0.178
Scientific value	Clinical significance of the research question	0.791	0.093	0.798	0.100	0.750	0.000
	Research design	0.581	0.187	0.581	0.198	0.563	0.161
Quality control	Staffs/committees and definition of the roles	0.372	0.249	0.383	0.255	0.359	0.240
	Data integrity	0.432	0.220	0.441	0.234	0.417	0.167
	Implementation quality control strategy	0.189	0.273	0.210	0.289	0.125	0.144
Stem cell products	Material harvest standards and SOPs	0.444	0.475	0.433	0.487	0.250	0.289
	Stem cell production standards and SOPs	0.389	0.290	0.406	0.303	0.300	0.258
	Product logistic and management plan	0.268	0.259	0.280	0.270	0.250	0.245

Exploratory phase includes phases 1, 1/2, and 2 trials. ^†Confirmatory phase includes phase 2/3 and phase 3 trials. ^§Standard error.