Skip to main content

Table 1 Characteristics of the 200 articles included.

From: What differences are detected by superiority trials or ruled out by noninferiority trials? A cross-sectional study on a random sample of two-hundred two-arms parallel group randomized clinical trials

Characteristics

Superiority trials

(n = 100)

Noninferiority trials

(n = 100)

P-value*

Journals, No. (%)

  

0.24**

   N Engl J Med

14 (14)

21 (21)

 

   J Clin Oncol

5 (5)

8 (8)

 

   JAMA

6 (6)

10 (10)

 

   Pediatrics

11 (11)

7 (7)

 

   Lancet

10 (10)

4 (4)

 

   Other

54 (54)

50 (50)

 

Years of publication, No. (%)

  

0.99

   2004-2006

59 (59)

59 (59)

 

   2007-2009

41 (41)

41 (41)

 

Justification for the treatement difference, No (%)

  

0.02

   Yes (by published or pilot studies)

59 (59)

49 (49)

 

   No

41 (41)

61 (61)

 

Medical specialty, No (%)

  

<0.001

   Cardio-vascular diseases

14 (14)

19 (19)

 

   Infectious diseases

3 (3)

23 (23)

 

   Oncology

6 (6)

10 (10)

 

   Other

77 (77)

48 (48)

 

Intervention, No. (%)

  

0.02

   Pharmacological

54 (54)

73 (73)

 

   Surgery

8 (8)

3 (3)

 

   Strategy (diagnosis or management)

34 (34)

18 (18)

 

   Other

4 (4)

6 (6)

 

Patient categories, No. (%)

  

0.18**.

   Adults (including elderly)

77 (77)

82 (82)

 

   Neonates and children < 18 yrs

18 (18)

18 (18)

 

   Mother and child

5 (5)

0 (-)

 

Primary outcome, No. (%)

  

<0.001

   Dichotomous

60 (60)

86 (86)

 

   Continuous

40 (40)

14 (14)

 

Type of outcome, No. (%)

  

0.17

   Mortality

12 (12)

19 (19)

 

   Other

88 (88)

81 (81)

 

Statistician/epidemiologist involved, No. (%)

   

   Yes

46 (46)

54 (54)

0.32

   No

54 (54)

46 (46)

 

Median power (interquartile range)

0.80 (0.80-0.90)

0.82 (0.80-0.90)

0.02***

Multicenter trial, No. (%)

  

0.001

   Yes

67 (67)

86 (86)

 

   No

33 (33)

14 (14)

 

Median sample size (interquartile range)

248 (118-633)

500 (300-900)

<0.001***

   Funding source, No. (%)

  

0.004**

   Study supported by the industry

50 (50)

70 (70)

 

   Study supported by institutional funds

33 (33)

25 (25)

 

   No funding source or not stipulated

17 (17)

5 (5)

 
  1. * Comparisons between superiority and noninferiority trials, ** Fisher's exact test, *** Mann-Whitney test