End point of clinical trials
Encyclopedia
An endpoint is something which is measured in a clinical trial
or study. Measuring the selected endpoints is the goal of a trial. The response rate
and survival
are examples of the endpoints.
A clinical trial will usually define or specify a primary endpoint as a measure that will be considered success of the therapy being trialled (eg. in justifying a marketing approval). The primary endpoint might be a statistically significant improvement in median
overall survival (OS). A trial might also define one or more secondary endpoints such as median progression-free-survival (PFS) that will be measured and are expected to be met. A trial might also define exploratory endpoints that are less likely to be met.
Frequently the median
is used so that the trial endpoint can be calculated once 50% of subjects have reached the endpoint.
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
or study. Measuring the selected endpoints is the goal of a trial. The response rate
Response rate
Response rate in survey research refers to the number of people who answered the survey divided by the number of people in the sample...
and survival
Survival rate
In biostatistics, survival rate is a part of survival analysis, indicating the percentage of people in a study or treatment group who are alive for a given period of time after diagnosis...
are examples of the endpoints.
A clinical trial will usually define or specify a primary endpoint as a measure that will be considered success of the therapy being trialled (eg. in justifying a marketing approval). The primary endpoint might be a statistically significant improvement in median
Median
In probability theory and statistics, a median is described as the numerical value separating the higher half of a sample, a population, or a probability distribution, from the lower half. The median of a finite list of numbers can be found by arranging all the observations from lowest value to...
overall survival (OS). A trial might also define one or more secondary endpoints such as median progression-free-survival (PFS) that will be measured and are expected to be met. A trial might also define exploratory endpoints that are less likely to be met.
Typical cancer trial endpoints
These are expressed as a period of time (survival duration) eg. in months.Frequently the median
Median
In probability theory and statistics, a median is described as the numerical value separating the higher half of a sample, a population, or a probability distribution, from the lower half. The median of a finite list of numbers can be found by arranging all the observations from lowest value to...
is used so that the trial endpoint can be calculated once 50% of subjects have reached the endpoint.