Favorite Datasets from Early Phases of Drug Research

Method Comparison Study

Part 3 - Table 6


As part of a larger study, 48 hypertensive patients from four clinics were allocated randomly to receive either 0, 25, or 100 mg of Drug A or a therapeutically effective dose of a positive control (P). During a 24 hour observation period, angiotensin II levels in blood plasma were measured at four hours "post dosing" at study baseline (Bs), following the first dose of therapy (1st), and after two (Wk2) and six (Wk6) weeks of therapy. The angiotensin II levels were assayed using two procedures: HPLC RIA and Direct RIA.

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Part 3 - Table 6
Method Comparison Study
Angiotensin II Level (pg/nl)
     HPLC RIA      Direct RIA
Clinic Trt Pat Bs 1st Wk2 Wk6 Bs 1st Wk2 Wk6
1 25 4 15.0 14.2 14.3 22.0 12.0 17.0 16.3 26.7
1 100 3 2.2 10.0 25.1 15.6 7.6 12.3 30.6 17.4
1 100 6 0.9 2.2 2.5 1.3 4.0 3.9 6.3 7.5
1 P 2 8.0 1.8 0.4 0.8 6.5 3.8 4.5 5.3
1 0 1 7.0 6.2 5.3 7.5 11.2 9.3 6.5 7.7
1 0 13 5.4 4.2 3.6 2.7 6.2 6.9 8.5 6.9
2 25 19 0.4 1.0 1.2 0.7 3.7 6.1 4.1 3.5
2 25 22 3.0 8.7 8.7 10.0 5.4 11.9 11.9 12.5
2 25 25 3.2 8.0 7.5 1.8 7.4 10.5 31.5 6.6
2 100 20 1.0 0.1 2.7 0.1 3.3 8.2 4.0 5.0
2 100 24 7.0 10.9 11.0 14.4 9.8 14.3 13.2 12.4
2 100 28 6.5 39.9 25.0 20.2 10.0 42.6 30.5 21.5
2 100 31 1.7 3.5 9.5 6.6 4.0 5.9 9.6 7.5
2 P 17 0.9 0.7 0.6 0.1 3.9 3.1 4.0 5.0
2 P 23 6.2 1.7 2.2 0.1 10.9 5.4 8.2 11.6
2 P 26 0.1 0.1 0.1 0.1 3.4 3.2 2.8 3.1
2 P 29 5.6 0.6 2.7 MS 6.0 3.6 19.4 3.3
2 0 18 1.1 1.2 2.1 1.7 4.3 4.8 5.4 8.9
2 0 21 5.4 4.1 2.8 2.6 11.1 6.9 5.7 13.2
2 0 27 2.0 2.3 2.1 1.1 3.9 6.9 7.0 5.2
2 0 30 7.6 4.9 MS 7.2 6.2 5.7 5.2 6.3
3 25 35 0.7 0.9 0.1 1.2 3.4 2.7 3.1 3.1
3 25 37 0.7 0.6 0.8 1.7 3.6 3.1 4.1 5.0
3 25 44 1.1 2.4 4.9 4.6 5.3 6.1 9.9 7.0
3 25 46 0.7 0.7 0.7 3.3 4.7 4.5 4.0 13.1
3 100 33 2.5 3.3 22.2 10.1 6.4 8.1 14.0 17.8
3 100 38 0.6 1.1 1.0 0.8 3.7 4.4 5.4 4.2
3 100 43 1.9 3.0 15.9 4.8 6.4 7.4 22.4 8.6
3 100 48 2.0 18.9 16.2 14.7 4.2 22.8 18.9 13.4
3 P 34 4.6 0.9 1.1 2.3 10.0 5.2 3.1 3.5
3 P 39 3.8 0.1 3.0 1.5 4.9 4.5 5.0 6.6
3 P 42 3.4 1.2 1.2 0.6 3.9 3.9 7.0 6.4
3 P 47 1.7 1.5 0.5 0.6 4.3 3.8 3.8 4.1
3 0 36 2.2 1.3 2.6 2.7 3.7 3.5 4.8 4.1
3 0 40 4.9 2.1 5.9 6.0 8.3 5.4 14.4 11.0
3 0 41 1.9 2.4 4.5 4.9 6.4 6.2 20.7 10.8
3 0 45 0.1 0.3 1.6 1.6 5.0 3.5 5.4 4.0
3 0 117 1.8 1.2 MS 5.6 5.2 5.3 6.0 6.5
4 25 53 6.6 10.6 39.7 14.4 6.6 9.5 46.5 20.0
4 25 60 6.6 6.5 6.7 2.3 7.7 7.2 7.1 6.5
4 100 49 MS MS MS MS 10.9 18.4 11.8 18.3
4 100 58 3.8 10.3 4.7 12.1 6.0 14.3 8.1 15.7
4 100 61 3.1 6.9 62.0 19.9 10.0 8.4 68.9 22.0
4 P 51 MS MS 5.3 3.7 18.5 5.0 10.0 6.5
4 P 54 MS MS 1.6 1.1 5.7 5.1 6.0 4.8
4 P 57 6.2 1.8 9.2 8.0 9.1 5.7 7.2 7.5
4 0 59 7.0 4.8 8.2 5.4 9.6 8.9 10.7 6.8
4 25 50 MS MS MS MS 5.5 5.5 5.2 8.2

MS = Data Missing


Source:

Bradstreet, T.E. (1994) "Favorite Data Sets from Early Phases of Drug Research - Part 3." Proceedings of the Section on Statistical Education of the American Statistical Association.

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Last modified December 24, 1997 - THS