| Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access |
| Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc |
| Journal website http://www.jocmr.org |
Original Article
Volume 5, Number 5, October 2013, pages 401-406
Participant Preferences for the Provision of Registration Trials Results
Tables
| Strongly agree | Agree | Neutral | Disagree | Strongly disagree | No answer | Total | |
|---|---|---|---|---|---|---|---|
| a. Do you want to be informed concerning your own allocation in the registration trial?/td> | 29 (50.9%) | 14 (24.6%) | 1 (1.8%) | 3 (5.3%) | 0 | 10 (17.5%) | 57 |
| b. Do you want to be informed concerning your own allocation in the registration trial, even if you were treated with placebo?/td> | 28 (49.1%) | 14 (24.6%) | 2 (3.5%) | 2 (3.5%) | 1 (1.8%) | 10 (17.5%) | 57 |
| Strongly agree | Agree | Neutral | Disagree | Strongly disagree | No answer | Total | |
|---|---|---|---|---|---|---|---|
| a. Do you want to be informed of the results (efficacy and safety) of the registration trial in which you participated?/td> | 34 (59.6%) | 17 (29.8%) | 2 (3.5%) | 1 (1.8%) | 1 (1.8%) | 2 (3.5%) | 57 |
| b. Do you want to be informed of the results (efficacy and safety) of the registration trial in which you participated, even if negative?/td> | 31 (49.1%) | 17 (29.8%) | 4 (7.0%) | 1 (1.8%) | 1 (1.8%) | 3 (5.3%) | 57 |
| c. Do you want to be informed of the state of labeling of the drug examined in the registration trial in which you participated?/td> | 32 (56.1%) | 13 (22.8%) | 5 (8.8%) | 0 | 0 | 7 (12.3%) | 57 |
| d. Do you want to be informed of the state of labeling of the drug examined in the registration trial in which you participated, even if drug development has ceased?/td> | 30 (52.6%) | 15 (26.3%) | 7 (12.3%) | 1 (1.8%) | 0 | 4 (7.0%) | 57 |
| Participants who agreed to provision of information | ||
|---|---|---|
| Participants with difficult-to-treat diseases (n = 36) | Participants with other types of diseases (n = 21) | |
| a, b, c, d, e, fSignificant differences (P = 0.008, 0.005, 0.048, 0.013, 0.021, 0.021, respectively) compared with participants with difficult-to-treat diseases. | ||
| 1-a. Do you want to be informed of your allocation in the registration trial?/td> | 23 (63.9%) | 20 (95.2%) a |
| 1-b. Do you want to be informed of your own allocation in the registration trial, even if you were treated with placebo?/td> | 22 (61.1%) | 20 (95.2%) b |
| 2-a. Do you want to be informed of the result (efficacy and safety) of the registration trial in which you participated?/td> | 30 (83.3%) | 21 (100%) c |
| 2-b. Do you want to be informed of the result (efficacy and safety) of the registration trial that you participated, even if negative?/td> | 27 (75.0%) | 21 (100%) d |
| 2-c. Do you want to be informed of the state of labeling of the drug examined in the registration trial in which you participated?/td> | 25 (69.4%) | 20 (95.2%) e |
| 2-d. Do you want to be informed of the state of labeling of the drug examined in the registration trial in which you participated, even if drug development has ceased?/td> | 25 (69.4%) | 20 (95.2%) f |
| Physician | CRC | Officer | No answer | Total | |
|---|---|---|---|---|---|
| 1 (1.8%) | 0 | 0 | 0 | 1 (1.8%) | |
| Telephone | 1 (1.8%) | 1 (1.8%) | 0 | 0 | 2 (3.5%) |
| Posted letter | 8 (14.0%) | 7 (12.3%) | 4 (7.0%) | 0 | 19 (33.3%) |
| Face-to-face | 25 (43.9%) | 6 (10.5%) | 1 (1.8%) | 0 | 32 (56.1%) |
| No answer | 0 | 0 | 0 | 3 (5.3%) | 3 (5.3%) |
| Total | 35 (61.4%) | 14 (24.6%) | 5 (8.8%) | 3 (5.3%) | 57 (100%) |