Considerations | FDA3 | Considerations | EMEA/EMA9 |
Emergency settings with no informed consent | Required | ||
Risk to clinical trial participant, that is,
| Recommended | Risk to clinical trial participant, that is,
| Recommended |
Practicality of IDMC, that is, | Practicality of IDMC, that is, | ||
| May be impractical |
| May be impractical |
| Consider | ||
Ensuring scientific validity and perception of the trial, that is,
| Consider | Ensuring scientific validity and perception of the trial, that is,
| May be indicated |
Clinical trial examining lesser outcomes (eg, symptom relief)‡ | Generally not needed |
*For example, study participants who may be children, or pregnant women, or very elderly, or terminally ill, or have diminished mental capacity.
†Trials that are conducted over a long period of time may be affected by changes over time (ie, changes in the standard of treatment, or in the understanding of the disease, etc). These external changes may prompt an interest in modifying some aspects of the trial as it progresses.
‡Unless there is an elevated risks of more severe outcomes.
EMA, European Medicines Agency; EMEA, European Medicines Evaluation Agency; FDA, Food and Drug Administration; IDMC, independent data monitoring committee.