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Table 2 Results of the 18 non-inferiority studies

From: Methodological standards in non-inferiority AIDS trials: moving from adherence to compliance

 

Δ Maximum difference % (hypothesis)

δ (%)*

UBCI§ of δ (%)

Non-inferiority D-value (type of analysis)

Superiority P-value (ITT)

Abstract authors' conclusion as compared with active-control for primary endpoint

CNAAB3005

12 (E)

7.3

14.3

0.17 (OT)

0.90

Was equivalent to

NEFA

13.5 (NI)

     

(a)

 

3.9

9.8

< 0.001 (ITT)

0.20

No conclusion

(b)

 

8.5

15.8

0.14 (OT)

0.035

A trend toward higher rate of [failure]

BEST

15 (NI)

15.7 (ITT)

25.9 (ITT)

1.0 (ITT)

0.003

Superiority of control in ITT

  

0.7 (OT)

7.2 (OT)

< 0.001 (OT)

1.0 (OT)

Non-inferiority in OT

2NN

10 (E)

     

(a)

 

5.9

14.0

0.36 (ITT)

0.15

Showed similar efficacy

(b)

 

7.7

14.6

0.56 (OT)

0.091**

Showed similar efficacy

(c)

 

15.4

23.6

0.24 (ITT)

0.0003

Did not show efficacy

903

10 (NI)

4.1

10.3

0.07 (ITT)

0.19

Highly effective and comparable***

SOLO

12 (NI)

-1.0

6.1

< 0.001 (ITT)

0.78

Provided durable [efficacy]

FTC-303

15 (NI)

5.0

12.9

< 0.01 (ITT)

0.234

Was equivalent to

EPV20001

12 (E)

-0.1

3.6

< 0.001 (OT)

0.81

Regimens were equivalent

ALIZE

15 (NI*)

-2.9

3.6

< 0.001 (ITT)

0.39

Associated with sustained [efficacy]

CNA30024

12 (NI)

-0.8

-6.3

< 0.001 (ITT)

0.82

Not inferior to

BMS-2004

10 (NI)

3.9

9.7

0.043 (OT)

0.16

As efficacious as

ESS40013

12 (NI)

6.1

13.5

0.09 (OT)

0.77

Maintained [efficacy]

SEAL

12 (NI*)

-1.5

4.3

< 0.001 (ITT)

0.61

Not inferior to

BMS-045

NA (NI)

     

(a)

 

8.0***

20.4***

NA (ITT)

0.21

As effective as

(b)

 

19.5***

32.2***

NA (ITT)

0.003

Efficacy was lower than

CNA30021

12 (NI)

2.2

6.6

< 0.001 (OT)

0.61

Not inferior to

CONTEXT

NA (NI)

     

(a)

 

14.0***

28.0***

NA (OT)

0.07

Not shown to be as effective as

(b)

 

10.0***

23.0***

NA (ITT)

0.30

Not shown to be as effective as

SHAART

15 (NI)

2.1

17.4

0.13 (ITT)

0.784

Not inferior to

934

13 (NI)

-3.5

0.5

< 0.001 (OT)

< 0.005

Fulfilled criteria for non-inferiority and proved superior

  1. § Bold UBCI exceeded the pre-specified non-inferiority margin
  2. *A positive δ corresponds to a higher efficacy of the active-control group, as compared with the experimental group. We choose the OT or ITT in a worst case basis, unless the authors reached separate conclusions for OT and ITT. The numbers may differ from original reports because original reports were stratum-adjusted or used 90% confidence interval.
  3. ** If patients who never started treatment were excluded, P = 0.03
  4. ***Based on secondary endpoints
  5. Abbreviations: δ : Observed difference between the % of success observed in the control arm minus the % of success observed in the experimental arm ; UBCI : upper bound of the 95% confidence interval; E: equivalence; NI: non-inferiority