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In many clinical trials and other experimental settings, the primary endpoint is some critical event. In analgesic studies such as postdental-extraction pain or postpartum pain, the event is relief of pain. In an anti-infective study such as chronic urinary tract infection, the event is microbiological cure or abatement of clinical signs and symptoms of the infection. In oncology studies such as carcinoma of the breast, head and neck cancer, liver cancer, colorectal cancer, etc., the primary event is death. However, if the primary treatment is surgery, which leaves the patient with no evidence of disease, another important event in patient follow-up is evidence of disease or recurrence. In a study of bladder tumors, e.g., important events in patient follow-up are remission or progression. In transplantation studies involving renal allografts, although death is ‘‘primary,’’ rejection may be the primary event reflecting the experimental objective. Similarly, in long-term chronic toxicity studies of rodents, tumor development may directly reflect the experimental objective more than death.
In such studies, participants are usually monitored for a specified length of time. The frequency of follow-up may vary depending on the disease being studied, e.g., daily, weekly, monthly, quarterly, biannually, or over unequally spaced intervals. Seldom, if ever, would follow-up be less frequent than quarterly. Follow-up on each participant permits the recording of the observed occurrence or nonoccurrence of the event during the monitoring period. If the event is not observed to occur, it could be that the observation time was censored due to the subject’s withdrawal prior to the end of the study (moved away from the area, died from causes unrelated to disease or treatment under study, adverse event unrelated to study conditions that prevented subject’s continued study participation, etc.) or due to the study coming to an end.
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