Table 1. Measures implemented in early-development clinical trials to mitigate the risk of unintended pregnancies.
| Topic | Responses |
|---|---|
| Methods routinely used to avoid unintended drug exposure during pregnancy in clinical trials (44 respondents) | Adequate contraceptive methods in in/exclusion criteria: 43 In female trial participants, pregnancy test at screening: 39 In female trial participants, pregnancy test before first dose: 37 In female trial participants, documentation of last menstrual period (LMP) at screening: 18 In female trial participants, documentation of LMP before first dose: 5 |
| Routine compliance checks whether subjects used contraceptive methods, how and when they used contraceptive methods (42 respondents) | Yes: 23 No: 19 |
| Procedures in place on what to do if contraceptive methods failed (42 respondents) | Yes: 25 No: 17 |
| Training physicians in instructing trial participants on how to use the contraceptive methods as specified in the clinical trial protocol (42 respondents) | Yes: 26 No: 16 |