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Table 2 Baseline characteristics of clinical trials associated with the changing year (n = 277)

From: The changing landscape of phase II/III metastatic sarcoma clinical trials—analysis of ClinicalTrials.gov

Characteristics

Number of trials (%)

P value

Before to 2007 year

2008–2017 year

Trial phase

0.048

Phase I/II

10 (10.4)

38 (21.0)

 

Phase II

78 (81.3)

122 (67.4)

 

Phase II/III

0 (0)

4 (2.2)

 

Phase III

8 (8.3)

17 (9.4)

 

Sponsor

0.215

NIH

16 (16.7)

17 (9.4)

 

Industry

20 (20.8)

40 (22.1)

 

Other

60 (62.5)

124 (68.5)

 

Number of centers

0.560

1

32 (33.3)

65 (35.9)

 

2

1 (1.0)

5 (2.8)

 

multicenter

63 (65.6)

111 (61.3)

 

Number of arms

0.007

1

79 (82.3)

117 (64.6)

 

2

13 (13.5)

54 (29.8)

 

≥3

4 (4.2)

10 (5.5)

 

Treatment allocation

0.002

Non-randomized

83 (86.5)

126 (69.6)

 

Randomized

13 (13.5)

55 (30.4)

 

Masking

0.024

Open-label

94 (97.9)

164 (90.6)

 

Double-blind

2 (2.1)

17 (9.4)

 

Region

< 0.001

United states

77 (80.2)

109 (60.2)

 

Europe

18 (18.8)

47 (26.0)

 

Asia

1 (1.0)

25 (13.8)

 

Therapy

Chemotherapy

55 (57.3)

40 (22.1)

< 0.001

Target therapy /immunology therapy

36 (37.5)

130 (71.8)

 

other

5 (5.2)

11 (6.1)

 
  1. Percentage of trial characteristics with each inclusion criteria group. Chi-squared test was used for class variables NIH, National Institutes of Health