The Enrollment/Continuation Decision

Abstract

This is the critical decision in the research process for both the patient and the investigator. It marks the transition for the patient from private or usual medical care to research care. The investigator is committing the patient to a course of action and therapy in the study by prescribing the study medication. Much of the “pressure” in the conduct of a study also centers around this decision. Rapid recruitment of an adequate number of patients who qualify is the name of the research game—good investigators recruit enough good patients for the study.