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Table 4 Secondary endpoint discrepancies stratified by endpoints absent from the protocol and absent from the registry

From: Discrepancies in endpoints between clinical trial protocols and clinical trial registration in randomized trials in oncology

 

Number of trials n = 71 (%)

Secondary Endpoints absent from registry n = 36 (%)

P value

Secondary Endpoints absent from protocol n = 19 (%)

P value

Trial Initiation Period

 1994–2005

30 (42)

15 (42)

0.9191

8 (42)

0.9878

 2006–2010

41 (58)

21 (58)

 

11 (58)

 

Trial Result

 Negative

37 (52)

22 (61)

0.1237

10 (53)

0.9578

 Positive

34 (49)

14 (39)

 

9 (47)

 

Funding Source

 Non-pharma

33 (46)

13 (36)

0.0757

8 (42)

0.6551

 Pharma

38 (54)

23 (64)

 

11 (58)

 

Duration of Trial

 < 3 years

30 (42)

18 (50)

0.1802

9 (47)

0.5979

 ≥ 3 years

41 (58)

18 (50)

 

10 (53)

 

Number of protocol non-primary endpointsa

 ≤ 6

36 (51)

15 (42)

0.1224

9 (47)

0.7340

 > 6

35 (49)

21 (58)

 

10 (53)

 

Protocol Lengtha

 ≤ 34 pages

36 (51)

18 (50)

0.8292

8 (42)

0.0326

 > 34 pages

35 (49)

18 (50)

 

11 (58)

 

Study Phaseb

 II

10 (14)

6 (17)

0.5993

3 (16)

0.3972

 III

57 (50)

29 (81)

 

14 (74)

 

Study Intervention

 Systemic

53 (75)

30 (83)

0.0880

15 (79)

0.7624

 Non-systemic

18 (25)

6 (17)

 

4 (21)

 

Protocol Type

 Full

60 (85)

31 (86)

0.7048

18 (95)

0.2670

 Appended

11 (15)

5 (14)

 

1 (5)

 
  1. aDichotomized at the median
  2. b4 unspecified trials not included