What is Hard Endpoint?
Hard Endpoint definition and meaning on Health terms:
The endpoint of a clinical trial is a pre-defined event: for instance, the occurrence of a disease, the occurrence of a symptom, or a particular laboratory result. Once someone reaches the endpoint, they are generally excluded from further research in the trial. A hard endpoint is an endpoint that is well defined and can be measured objectively. For example, in cancer research, the endpoint in a trial might be related to response to treatment (such as shrinkage of a tumour). Endpoints related to a response are typical in Phase II clinical trials for cancer treatments. Endpoints relating to the survival of patients are common in Phase III cancer trials. ‘Progress free survival’ and ‘disease free survival’ measure the length of time patients are alive without their disease worsening. In contrast to hard endpoints, soft endpoints are subjective measures. Quality of life measures, for example, are soft endpoints. It is common to use quality of life measures as endpoints in(. . . )