Seeing the value in observational studies
Executive Summary
Safety signals identified in observational studies require confirmation but provide important information about drug use in a real-world setting, according to a pair of opinion pieces in the Nov. 23 issue of the New England Journal of Medicine; both articles addressed Bayer's failure to disclose a large observational study on its drug Trasylol before a recent advisory committee review (1"The Pink Sheet" Oct. 2, 2006, p. 25). "Although observational studies cannot be definitive...they can provide important new safety information that can direct further scientific and regulatory actions - if their findings can be confirmed," Cardio-Renal Drugs Advisory Committee chair William Hiatt (University of Colorado) said. Jerry Avorn (Harvard Medical School) advises care with application of epidemiological research techniques, and argues that transparency of study methods and raw data are critical to interpreting results that are confounded in such uncontrolled studies...
You may also be interested in...
Trasylol Safety Review Raises Questions About Role Of Observational Data
FDA continues to grapple with the relative benefits of observational data and randomized controlled trials to evaluate drug safety
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
P&G Restores Volume Growth In Beauty, Grooming After Pricing Run
Procter & Gamble reports strong consumer spending in the US and Europe after a 3% increase in product pricing over the past year. Dragging on fiscal third-quarter results, sales of SK-II in China fell 30% for the January-March period, while lower incidence of cough and cold impacted Health Care performance.