In a general sense, a clinical endpoint is included in the entities of interest in a trial.
The results would ultimately reflect the fraction of patients who reached the endpoint of having developed chest pain, compared with the overall number of people enrolled.
A clinical trial will usually define or specify a primary endpoint as a measure that will be considered success of the therapy being trialled (e.g. in justifying a marketing approval).
A trial might also define one or more secondary endpoints such as progression-free-survival (PFS) that will be measured and are expected to be met.
These rates are generally low to zero as clinical trials are typically halted when toxic deaths occur.
Serious adverse events are defined by the US Food and Drug Administration as "Any AE occurring at any dose that results in any of the following outcomes: A humane endpoint can be defined as the point at which pain and/or distress is terminated, minimized or reduced for an entity in a trial (such as an experimental animal), by taking action such as killing the animal humanely, terminating a painful procedure, or giving treatment to relieve pain and/or distress.
[5][6][7] Some studies will examine the incidence of a combined endpoint, which can merge a variety of outcomes into one group.
For example, the heart attack study above may report the incidence of the combined endpoint of chest pain, myocardial infarction, or death.
Overall Treatment Utility is an example of a multidimensional composite endpoint in cancer clinical trials.
[citation needed] The response rate is the percentage of patients on whom a therapy has some defined effect; for example, the cancer shrinks or disappears after treatment.
[9] When used as a clinical endpoint for trials of cancer treatments, this is often called the objective response rate (ORR).
[10][11] The FDA definition of ORR in this context is "the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period.