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Table 2 Items of primary concern and secondary concern for analyses

From: Review of the registration of clinical trials in UMIN-CTR from 2 June 2005 to 1 June 2010 - focus on Japan domestic, academic clinical trials

Primary concern

Secondary concern

1. Malignancy/other

1. Objective

2. Genomic information

2. Developmental phase

3. Confirmatory/exploratory

3. Randomization unit

4. Explanatory/pragmatic

4. Stratification

5. Basic design

5. Dynamic allocation

6. Randomization

6. Institution consideration in allocation

7. Blinding

7. Concealment

8. Control

8. Blocking in allocation

9. Number of arms

9. Purpose of intervention

10. Type of intervention

10. Lower age limit

11. Target sample size

11. Sex

12. Trial period

12. Primary sponsor

13. Publication of results

13. Funding source

14. Disclosure of trial before/after trial start

 

15. Disease classification by specialty

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