pISSN 1226-6051
eISSN 2508-786X
eISSN 2508-786X
Differences in provision of additional information
| Provision of additional study information | N (%) | X2 (p) | OR [95% CI] | ||
|---|---|---|---|---|---|
| Enforcement of regulations (Oct 25, 2018) | |||||
| Before | After | ||||
| Clinical trial phase | Yes | 9(15.0) | 45(58.4) | 26.6(.000) | 7.9 [3.43-18.4] |
| No | 51(85.0) | 32(41.6) | |||
| Exclusion criteria | Yes | 9(15.0) | 61(79.2) | 0.7(.385) | 1.4 [0.60-3.64] |
| No | 51(85.0) | 16(20.8) | |||
| Information of investigational product | Yes | 25(41.7) | 69(89.6) | 35.9(.000) | 12.0 [4.93-29.52] |
| No | 35(58.3) | 8(10.4) | |||
| Study period | Yes | 57(95.0) | 75(97.4)) | 0.5(.457) | 1.9 [0.31-12.20] |
| No | 3(5.0) | 2(2.6) | |||
| Number of target subjects | Yes | 8(13.3) | 13(16.9) | 0.3(.567) | 1.3 [0.50-3.42] |
| No | 52(86.7) | 64(83.1) | |||
| Laboratory test | Yes | 24(40.0) | 59(76.6) | 18.9(.000) | 4.9 [2.34-10.28] |
| No | 36(60.0) | 18(23.4) | |||
| Visit frequency | Yes | 55(91.7) | 74(96.1) | 1.2(.272) | 2.2 [0.51-9.78] |
| No | 5(8.3) | 3(3.9) | |||
| Benefit from study participation | Yes | 53(88.3) | 54(70.1) | 6.5(.011) | 0.3 [0.12-0.78] |
| No | 7(11.7) | 23(29.9) | |||
| Total | 60(100.0) | 77(100.0) | |||
OR, odds ratio; CI, confidence interval
* Additional information not specified in the Pharmaceutical Affairs Act