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Table 7 Percentage of trials re-estimating the sample size, conditional power among trials that re-estimated the sample size and overall mean and median sample size for sample size re-estimation using conditional power

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

Percent re-estimating sample size

Empirical conditional power

Mean sample size

Median sample size

Misspecification of the prognostic factor: 0%

5

10%

1,418

37.44%

0.9471

2,500

1,418

20%

798

37.30%

0.9566

1,470

798

30%

608

37.74%

0.9671

1,143

608

40%

532

38.00%

0.9689

984

532

50%

512

39.44%

0.9660

989

512

15

10%

178

37.44%

0.9701

327

178

20%

100

40.48%

0.9674

202

100

30%

78

39.28%

0.9695

150

78

40%

68

42.02%

0.9719

155

68

50%

64

43.58%

0.9748

154

64

Misspecification of the prognostic factor: -5%

5

10%

1,418

49.70%

0.8881

3,568

1,418

20%

798

43.12%

0.9429

1,696

798

30%

608

40.98%

0.9458

1,231

608

40%

532

38.56%

0.9570

1,062

532

50%

512

38.82%

0.9629

987

512

15

10%

178

45.00%

0.8738

402

178

20%

100

42.54%

0.9342

219

100

30%

78

43.56%

0.9660

171

78

40%

68

43.38%

0.9779

153

68

50%

64

44.40%

0.9770

155

64

Misspecification of the prognostic factor: -15%

5

10%

1,418

--

--

--

--

20%

798

51.98%

0.7618

2,425

865

30%

608

47.34%

0.8952

1,439

608

40%

532

44.96%

0.9346

1,155

532

50%

512

41.42%

0.9546

1,028

512

15

10%

178

--

--

--

--

20%

100

48.70%

0.7573

267

100

30%

78

46.80%

0.9167

190

78

40%

68

47.38%

0.9565

161

68

50%

64

44.50%

0.9685

148

64

Misspecification of the prognostic factor: +5%

5

10%

1,418

25.94%

0.9861

1,984

1,418

20%

798

33.26%

0.9747

1,310

798

30%

608

35.76%

0.9676

1,096

608

40%

532

37.68%

0.9618

975

532

50%

512

39.24%

0.9623

969

512

15

10%

178

28.32%

0.9845

263

178

20%

100

35.36%

0.9762

177

100

30%

78

37.42%

0.9840

153

78

40%

68

43.32%

0.9797

150

68

50%

64

45.72%

0.9790

157

64

Misspecification of the prognostic factor: +15%

5

10%

1,418

15.04%

0.9960

1,472

1,418

20%

798

27.34%

0.9824

1,159

798

30%

608

34.22%

0.9673

1,007

608

40%

532

38.58%

0.9725

1,026

532

50%

512

41.56%

0.9644

1,045

512

15

10%

178

14.40%

0.9944

190

89

20%

100

30.38%

0.9888

159

100

30%

78

37.62%

0.9856

149

78

40%

68

43.78%

0.9753

151

68

50%

64

48.00%

0.9708

168

64