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Overall Treatment Utility is an example of a multidimensional composite endpoint in cancer clinical trials. [8] Regarding humane endpoints, a combined endpoint may constitute a threshold where there is enough cumulative degree of disease, symptoms, signs or laboratory abnormalities to motivate an intervention. [citation needed]
FDA: Clinical trial endpoints for the approval of cancer drugs and biologics [17] provides recommendations to applicants on endpoints for cancer clinical trials submitted to the Food and Drug Administration (FDA) to support effectiveness claims in new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications.
Progression-free survival (PFS) is "the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse". [1] In oncology, PFS usually refers to situations in which a tumor is present, as demonstrated by laboratory testing, radiologic testing, or clinically. Similarly ...
Clinical Cancer Research is a peer-reviewed medical journal on oncology, including the cellular and molecular characterization, prevention, diagnosis, and therapy of human cancer, medical and hematological oncology, radiation therapy, pediatric oncology, pathology, surgical oncology, and clinical genetics.
This distinction must be made by both the treating physicians and the cancer patients themselves. Many oncologists in their daily clinical practice follow their patients' malignant disease by means of repeated imaging studies and make decisions about continuing therapy on the basis of both objective and symptomatic criteria.
The American Journal of Clinical Oncology is a bimonthly, peer-reviewed, scientific, oncology journal, published by Lippincott Williams & Wilkins. The editor in chief is David E. Wazer (Tufts University). The journal was formerly entitled Cancer Clinical Trials. [1] [2] [3] [4]
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