pISSN 1226-6051
eISSN 2508-786X
eISSN 2508-786X
Differences in provision of essential information
| Provision of essential information | N(%) | X2 (p) | OR [95% CI] | ||
|---|---|---|---|---|---|
| Enforcement of regulations (Oct 25, 2018) | |||||
| Before | After | ||||
| Study title | Yes | 45(75.0) | 76(98.7) | 18.3(.000) | 25.3 [10.05-1.49] |
| No | 15(25.0) | 1(1.3) | |||
| Study objectives | Yes | 46(76.7) | 76(98.7) | 16.7(.000) | 23.1 [2.94-181.75] |
| No | 14(23.3) | 1(1.3) | |||
| Study methods | Yes | 47(78.3) | 77(100) | 18.4(.000) | |
| No | 13(21.7) | 0(0.0) | |||
| Eligibility | Yes | 60(100.0) | 77(100.0) | - | |
| No | 0(0.0) | 0(0.0) | |||
| Inclusion criteria | Yes | 60(100.0) | 77(100.0) | - | |
| No | 0(0.0) | 0(0.0) | |||
| Corporate name of study sponsor | Yes | 3(5.0) | 61(79.2) | 74.6(.000) | 72.4 [20.04-261.80] |
| No | 57(95.0) | 16(20.8) | |||
| Address of study sponsor | Yes | 0(0.0) | 60(77.9) | 83.1(.000) | |
| No | 60(100.0) | 17(22.1) | |||
| Contact number of study sponsor | Yes | 1(1.7) | 60(77.9) | 79.3(.000) | 208.2 [26.80-1615.20] |
| No | 59(98.3) | 17(22.1) | |||
| Name of PI | Yes | 24(40.0) | 74(96.1) | 52.1(.000) | 37.0 [10.44-131.04] |
| No | 36(60.0) | 3(3.9) | |||
| Address of PI | Yes | 22(36.7) | 75(97.4) | 60.1(.000) | 64.7 [14.46-290.06] |
| No | 38(63.3) | 2(2.6) | |||
| Contact number of PI | Yes | 31(51.7) | 76(98.7) | 43.6(.000) | 35.0 [7.88-156.08] |
| No | 29(48.3) | 1(1.3) | |||
| Expected adverse event | Yes | 3(5.0) | 73(94.8) | 110.1(.000) | 346.7 [74.50-1611.81] |
| No | 57(95.0) | 4(5.2) | |||
| Total | 60(100.0) | 77(100.0) | |||
PI, principle investigator; OR, odds ratio; CI, confidence interval
* Essential information specified in the Pharmaceutical Affairs Act