American Statistical Association
When a new drug is developed, the sponsor must apply for drug approval from the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) before it can enter the market. The FDA then reviews the drug application in conjunction with data from clinical trials to determine whether the drug is safe and effective for a specific use or indication that is being proposed. If the FDA grants approval then the drug's label includes specific information regarding dosage, route of administration, and other information. Off-label use refers to the practice of prescribing a drug for an unapproved indication, which could include a different patient population, dose, or form of administration than what is included on the label. Once a drug has received approval from the FDA and is on the market, physicians may prescribe the drug for any condition. This component of medicine is not regulated and it is legal for physicians to prescribe a drug off-label and may in fact be standard medical practice to do so. This is an important and understudied area in oncology. We set out to estimate the frequency of off-label use of chemotherapeutic agents in a cohort of elderly breast and lung cancer patients. Since the safety of a drug in the off-label setting may not have been thoroughly examined, we examine rates of hospitalization among patients who received off-label therapies versus those who received FDA approved treatments. We will utilize the population based SEER-Medicare linked dataset to explore this topic.
|Date:||Wednesday, February 27, 2013|
|Time:||11:00 A.M. - 12:00 P.M.|
Memorial Sloan-Kettering Cancer Center
Department of Epidemiology and Biostatistics
307 East 63rd Street
(between First and Second Avenues)
3rd Floor Conference Room
New York, New York
Note: To gain access to the building, please follow the directions by the telephone in the foyer.