inglês para português Medicina Medicina: farmacêutica

See this definition in EN:

Explanation of Primary and Secondary Endpoints

Clinical trials are designed to provide clinically important and meaningful information on ****particular measures of efficacy and / or safety. These are called primary endpoints***. Analyses of primary endpoints can therefore generally be considered robust (i.e., they typically have greater scientific validity than analyses of secondary endpoints).

***Other measures of efficacy and safety are often assessed in clinical trials and referred to as secondary endpoints. **** Although clinical trials are typically not designed to provide robust information on secondary endpoints the information they provide can be important e.g., for hypothesis setting or to support the information obtained from primary endpoints. However it should be noted that:

1. The number of patients enrolled into clinical trials is usually based solely on providing clinically and statistically meaningful information for primary endpoints not secondary endpoints.

Therefore, a lack of statistical significance between treatments for secondary endpoints may be because the trial did not include enough patients (the trial is referred to as being underpowered for these endpoints). Conversely where there are statistically significant differences between treatments for secondary endpoints, it is important to recognise that this may be because the trial is oversensitive for these endpoints rather than the difference being clinically important (the trial is referred to as being overpowered for these endpoints).
2. The more secondary endpoints that are analysed the more difficult it can be to interpret statistical tests comparing treatments. This is because the more statistical tests that are conducted the more chance there is of finding a statistical difference which is not real or of missing a real difference.


How is 'endpoint' typically translated in PT clinical trial contexts?