FDA has implemented several policies and programs to accelerate the process of drug marketing

Investigator-initiated trials (IITs) are established and managed by non-pharmaceutical researchers, such as clinicians and researchers working in a health institution.

Disease-Specific Survival (DSS) refers to deaths caused specifically by a particular disease.

Milestone survival rate is defined as the survival probability at a given point in time.

Health-Related Quality of Life (HRQoL) is a significant indicator for assessing the quality of life and health status of patients.

Clinical Benefit Rate (CBR) is defined as the percentage of advanced cancer patients who achieve complete remission, partial remission, or at least six months of stable disease after treatment.

Pathological Complete Response (pCR) is commonly used as a surrogate marker for breast cancer and is defined as the absence of residual invasive cancer in the resected breast tissue and evaluated regional lymph node.

Complete response (CR) is defined as the absence of detectable tumor in the patient's body. Radiology and histopathology are used to measure CR, serving as surrogate or primary endpoints depending on the specific disease or use scenario.

Duration of Response (DoR) is defined as the time from randomization to disease progression or death for patients who achieve complete or partial alleviation.

Duration of Clinical Benefit (DoCB) is defined as the time from randomization to disease progression or death in patients who achieve complete remission, partial remission, or disease stability for 24 weeks or longer.

Time to Next Treatment (TTNT) is defined as the period from the start of the treatment to the start of the next line of treatment.

TTF, in comparison to PFS, synthesizes the effectiveness and safety characteristics of the drug, encompasses treatment failure for any reason and includes death.