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
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.