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Table 1 Clinical Translation of Cell Therapies in Stroke (CT2S): Checklist for efficiency in trial conduct

From: Clinical Translation of Cell Therapies in Stroke (CT2S) Checklist—a pragmatic tool to accelerate development of cell therapy products

Domain

Topic

Number of questions

Study design

Target population

4

 

Trial design

6

 

Study endpoint

3

 

Timing of study after stroke

4

 

Intervention

4

 

Medication

1

 

Comparator

3

 

Statistical analysis

2

 

Safety reporting

1

Regulatory

Intended cell therapy use

4

 

Cell therapy processing

9

 

Expertise in submission of clinical trial applications to regulators

1

Ethical

Patient and Public Involvement in Research (PPIR)

10

 

Study safety committee

1

Health economic

Cost outcomes

5