Delaware Chapter, ASA

Dinner Meeting: September 2002

Speaker: Rafia Bhore, Ph.D.
Center for Drug Evaluation & Research (CDER)
Food and Drug Administration (FDA)
Title: Quantitative Evaluation of Drug Safety: Experiences of an FDA Statistical Reviewer


Federal drug regulations require that prior to marketing a new drug in the United States, the Sponsor of a new drug submit to the Food and Drug Administration an integrated summary of all available data on the safety of the drug product. Upon FDA approval of the new drug, the data on its safety are summarized in the professional labeling of the drug. The drug label is a vehicle that instructs the prescribing physicians about the benefits and risks associated with the drug. Safety data typically are described in the "Adverse Reactions" section of the drug label which contains information on frequently occurring adverse events, serious adverse events, and potential safety hazards reported with the drug, regardless of the proof of a causal relationship to the drug.

Adverse events are often reported in the label in terms of frequencies or a crude incidence rate (number of events divided by number of subjects exposed). The approach of reporting crude rates may be appropriate for most adverse events that occur early in treatment or when patients are exposed short-term. However, such crude incidence rates may not be appropriate for characterizing serious adverse events (that occur after some delay of weeks, months or even years) due to long-term exposure with different hazard rates and with differential follow-up of exposed patients. In this talk, we discuss issues in reviewing safety data with respect to quality and content of safety databases in clinical trials. We will present some examples of time-dependent serious adverse events and discuss various statistical approaches in evaluating them. Finally we discuss possible survival analysis techniques that will explore the time-to-onset of serious adverse events and duration of serious adverse events.

Date: Thursday, September 26, 2002

Social hour -- 6:00 pm
Dinner -- 6:30 pm
Speaker -- 7:15 pm

Newark Holiday Inn
Oliver's Restaurant map

Appetizer: Soup du Jour
Salad: Caesar Salad
Entree: Stuffed Salmon Boats w/Cucumber Vinaigrette
Dessert: Parfait

If you desire a vegetarian meal, please so indicate in your RSVP.


$25 for members, $10 for students

Reservations to Lidia Rejto by Monday, September 23, 2002.
302-831-8034; or email to Lidia Rejto.

Please note: Be sure to RSVP by this date, to assure a meal is reserved for you.

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