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Table 1 Characteristics of 77 included studies, by non-inferiority and superiority trials

From: Clinical significance in pediatric oncology randomized controlled treatment trials: a systematic review

Characteristic

Non-inferiority trials (N = 11)

Superiority trials

(N = 66)

 

n

%

n

%

Journal of publication

 Journal of Clinical Oncology

3

27.3

25

37.9

 Blood

2

18.2

10

15.2

 Pediatric Blood & Cancer

0

0.0

6

9.1

 Leukemia

1

9.1

4

6.1

 Lancet

2

18.2

1

1.5

 Cancer

0

0.0

4

6.1

 Lancet Oncology

1

9.1

3

4.5

 New England Journal of Medicine

1

9.1

2

3

 Other

1

9.1

11

16.7

Region of publication

 Europe

6

54.5

23

34.8

 North America

4

36.4

41

62.1

 Other

1

9.1

2

3

Year of publication

 1976 to 1989

1

9.1

4

6.1

 1990 to 2003

4

36.4

28

42.4

 2004 to 2016

6

54.5

34

51.5

Source of funding

 Non-industry

10

90.9

56

84.8

 Industry and non-industry

0

0.0

2

3

 Not stated

1

9.1

8

12.1

Study participants

 Exclusively children

7

63.6

41

62.1

 Adults included

4

36.4

25

37.9

Disease site

 Hematological

7

63.6

43

65.2

 Central nervous system tumor

1

9.1

11

16.7

 Non-central nervous system solid tumor

3

27.3

12

18.2

RCT study design

 2 × 2 factorial

0

0.0

4

6.1

 Greater than 2 arms

1

9.1

5

7.6

 Two-armed

10

90.9

57

86.3

RCT trial group

 POG

1

9.1

15

22.7

 CCG

1

9.1

12

18.2

 COG

0

0.0

8

12.1

 BFM

1

9.1

9

13.6

 UK MRC

1

9.1

4

6.1

 Other

7

63.6

18

27.3

Outcome

 Time-to-event

10

90.9

56

84.8

 Dichotomous

1

9.1

10

15.2

Intervention in question

 Chemotherapy

9

81.8

57

86.4

 Multimodal therapy

0

0.0

2

3

 Hemopoietic stem-cell transplant

1

9.1

6

9.1

 Radiation therapy

1

9.1

1

1.5

  1. RCT randomized control trial, POG Pediatric Oncology Group, CCG Children’s Cancer Group, COG Children’s Oncology Group, BFM Berlin Frankfurt Münster Study Group; UK MRC United Kingdom Medical Research Council