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Table 5 Designs with minimum cost among designs with 80% power of detecting the interaction

From: Flexible Two-Phase studies for rare exposures: Feasibility, planning and efficiency issues of a new variant

Gene-surrogate

Flexible two-phase design options

Expected Phase One counts

Power#

Cost*

Spec

Sens

n0

n1

ρ0

ρ1

N0

N1

  

70%

80%

700

500

90%

80%

5163

1525

81%

1534

70%

90%

600

500

90%

80%

4412

1472

80%

1394

80%

60%

700

300

90%

90%

7721

1491

80%

1461

80%

70%

600

300

90%

80%

6585

1259

80%

1292

80%

80%

500

300

90%

80%

5461

1200

80%

1133

80%

90%

400

400

90%

80%

4348

1528

81%

1094

90%

60%

400

400

70%

50%

6667

1683

81%

1217

90%

70%

500

300

50%

50%

5896

1169

80%

1153

90%

80%

500

300

40%

60%

4673

1307

80%

1099

90%

90%

500

300

40%

50%

4630

1019

82%

1082

  1. # Analysis approach: Maximum likelihood
  2. * the study cost is computed as the sum of the number of screened subjects divided by 20 plus the number of subjects included in Phase Two.
  3. † ρ0 is the proportion of SG + controls included in Phase Two
  4. ‡ ρ1 is the proportion of SG + cases included in Phase Two