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2. SAP Contents
2.1. Trial Primary and Secondary Endpoints
The primary endpoint of a clinical trial must correspond to the scientific objective of the trial. Both primary and secondary endpoints may be made up by several endpoints called a ’family of endpoints’. Secondary endpoints should provide supportive information
about a medicine’s effect on the primary endpoint or demonstrate additional effects on the disease or condition. Endpoints can be measured objectively (blood pressure, weight, survival time) or indicated subjectively by patients or clinicians on standard
score sets (e.g. level of pain, psoriasis area evaluation, outcome reports). The trial endpoints can be of several types: Continuous, binary or time-to-event endpoints.
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Continuous:
- Is made up of measured data (e.g. height, weight).
- Examples of continuous endpoints are blood pressure measurements or body temperature.
- Binary:
- Response Rate – how often a response occurs.
- Absolute frequency – how many times a response occurs.
- Relative frequency – for what percentage of participants does a response occur?
- Time-to-event (TTE):
- Time to progression (TTP): time from randomisation to progression of disease.
- Overall survival (OS): time from randomisation to death from any cause.
- ‘Event’ free survival (EFS): time from randomisation to either ‘event’ or death from any cause.
- ‘Event’ free interval (EFI): time from randomisation to either ‘event’ or death related to the disease evolution or treatment.*