Trial endpoints for drug approval in oncology: Chemoprevention.
As with other drugs, new drug applications for marketing approval of chemopreventive drugs must include data from adequate and well-controlled clinical trials that demonstrate effectiveness and safety for the intended use. This article summarizes the regulatory requirements for traditional marketing approval, as well as for approval under the accelerated approval regulations. Unlike traditional approval, accelerated approval is based on a surrogate endpoint that is reasonably likely to predict clinical benefit. Discussions with the Food and Drug Administration (FDA) regarding the validity of trial endpoints that may serve as surrogates for clinical benefit for accelerated approval should take place as early as possible in drug development. Meetings with the FDA to discuss these issues may be requested throughout the clinical development of a new drug.
Beitz
J
J
Food and Drug Administration, Center for Drug Evaluation and Research, Division of Oncology Drug Products, Rockville, Maryland 20857, USA.
D016588:Anticarcinogenic Agents / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy; D000068579:Celecoxib; D005260:Female; D006801:Humans; D007417:Intestinal Polyps / Q000188:drug therapy; D017387:Investigational New Drug Application / Q000331:legislation & jurisprudence* / Q000379:methods; D008297:Male; D011720:Pyrazoles; D013449:Sulfonamides / Q000627:therapeutic use; D013629:Tamoxifen / Q000627:therapeutic use; D014481:United States; D014486:United States Food and Drug Administration
D016588:Anticarcinogenic Agents; D011720:Pyrazoles; D013449:Sulfonamides; D013629:Tamoxifen; D000068579:Celecoxib