Event-Free Survival (EFS), compared to Disease-Free Survival (DFS), adds a surgical intervention criterion and is often used to evaluate neoadjuvant therapy pre-surgery, or radiotherapy.
Disease Control Rate refers to the proportion of patients who, according to internationally recognized criteria for alleviating evaluation, achieve tumor relief (PR+CR) and stable disease (SD) after treatment and can maintain for the minimum duration requirement.
PFS is a tumor measurement-based endpoint that primarily evaluates the anti-tumor activity of a drug and, to a certain extent, considers the drug's safety and patient survival (accidental death).
ORR is an index directly measuring the anti-tumor activity of a drug and is the most common endpoint based on tumor measurements, evaluated in single-arm trials.
Me-too drugs specifically refer to drugs with their own intellectual property rights, whose efficacy is comparable to that of innovative breakthrough drugs.
A protocol outlines the experiment's context, theory, and intent, its design, methodology, and structure including statistical considerations, and the conditions for execution and completion.
DSMB stands for Data Safety and Monitoring Board, an independent expert group established to safeguard the rights and needs of infants and young children participating in Phase III clinical trials.