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Table 4 Empirical type I error and percentage of trials switching to the quota sampling scheme for the modified quota sampling method

From: Impact of misspecifying the distribution of a prognostic factor on power and sample size for testing treatment interactions in clinical trials

θ

Planned distribution of the prognostic factor

Planned n t

Empirical type I error

Percent of trials switching to quota sampling

Misspecification of the prognostic factor: -5%

0

10%

1,418

0.0528

99.90%

20%

798

0.0506

74.26%

30%

608

0.0498

47.34%

40%

532

0.0480

36.66%

50%

512

0.0492

36.06%

0

10%

178

0.0566

34.74%

20%

100

0.0496

12.12%

30%

78

0.0528

11.24%

40%

68

0.0452

11.30%

50%

64

0.0522

8.80%

Misspecification of the prognostic factor: -15%

0

10%

1,418

--

--

20%

798

0.0500

100.00%

30%

608

0.0496

100.00%

40%

532

0.0518

99.92%

50%

512

0.0568

99.76%

0

10%

178

--

--

20%

100

0.0578

89.60%

30%

78

0.0522

62.82%

40%

68

0.0542

50.56%

50%

64

0.0478

41.20%

Misspecification of the prognostic factor: +5%

0

10%

1,418

0.0568

98.68%

20%

798

0.0490

68.74%

30%

608

0.0490

48.10%

40%

532

0.0508

36.48%

50%

512

0.0508

36.64%

0

10%

178

0.0504

34.46%

20%

100

0.0534

16.32%

30%

78

0.0496

10.90%

40%

68

0.0450

8.50%

50%

64

0.0502

8.94%

Misspecification of the prognostic factor: +15%

0

10%

1,418

0.0462

100.00%

20%

798

0.0490

100.00%

30%

608

0.0484

100.00%

40%

532

0.0516

99.76%

50%

512

0.0522

99.86%

0

10%

178

0.0452

97.48%

20%

100

0.0444

70.72%

30%

78

0.0526

51.00%

40%

68

0.0524

38.60%

50%

64

0.0528

40.72%

  1. The margin of error based on the 99% confidence interval is 0.008.