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Table 5 Association of trial characteristics with different reasons related to trial discontinuation a

From: General characteristics and reasons for the discontinuation of drug clinical trials in mainland China

Items

Drug development strategy

Trial planning

Trial conduct

Studied drug

P

Study design

 Parallel assignment (n = 171)b

57 (33.3)

58 (33.9)

9 (5.3)

47 (27.5)

0.164d

 Crossover assignment (n = 111)b

31 (27.9)

30 (27.0)

15 (13.5)

35 (31.5)

 Single group assignment (n = 32)

10 (31.3)

12 (37.5)

1 (3.1)

9 (28.1)

Blinding status

 Open label (n = 179)b

49 (27.4)

58 (32.4)

18 (10.1)

54 (30.2)

0.240e

 Single blind (n = 14)b

5 (35.7)

5 (35.7)

2 (14.3)

2 (14.3)

 Double blind (n = 121)

44 (36.4)

37 (30.6)

5 (4.1)

35 (28.9)

No. of centers

 Single center trial (n = 144)b

45 (31.3)

45 (31.3)

5 (3.5)f

49 (34.0)

0.028d

 Multiple center trial (n = 170)

53 (31.2)

55 (32.4)

20 (11.8)

42 (24.7)

Sample size c

  < 100 participants (n = 157)b

48 (30.6)

48 (30.6)

18 (11.5)

43 (27.4)

0.002d

 100–499 participants (n = 109)b

37 (33.9)

42 (38.5)

7 (6.4)

23 (21.1)

  > 500 participants (n = 37)b

7 (18.9)

7 (18.9)

2 (5.4)

21 (56.8)g

Has enrolled participants

 Yes (n = 136)b

26 (19.1)h

37 (27.2)

10 (7.4)

63 (46.3)h

< 0.001d

 No (n = 178)b

72 (40.4)

63 (35.4)

15 (8.4)

28 (15.7)

  1. Data was presented as n (%)
  2. a: 5 trials did not give a reason for discontinuation
  3. b: Coded multiple times for trials with multiple reasons recorded
  4. c: We excluded trials not record planned sample size
  5. d: Pearson chi-square test
  6. e: Fisher’ s exact test
  7. f: Significantly different from the multiple center trial group by Bonferroni correction (P < 0.05)
  8. g: Significantly different from the < 100 participants group and the 100–499 participants group by Bonferroni correction (P < 0.05)
  9. h: Significantly different from the no group by Bonferroni correction (P < 0.05)