In December 2018 the FDA released new guidelines for clinical trials of cancer drugs and biologics. Such endpoints serve different purposes at different points in time during the trial. During early trials the focus is on efficacy and safety. Later on, trials select endpoints for clinical benefits like improved survival and symptom relief.

 

For cancer patients, the survival rate is considered the optimum endpoint all other things being equal. Tumor assessment and symptom assessment are two other common endpoint categories.

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