Letters to the Editor
Readers respond to articles and editorials.
Parents for Orphans
A new guideline details basic requirements for submitting a successful application for a proposed orphan drug in the European Union.
Fraud, Abuse, and Consent
Federal prosecutors target sponsors and clinical investigators who misuse federal funds or violate research requirements while FDA proposes new policies and Congress eyes reforms.
Identifying and Documenting Adverse Events at Clinical Study Sites
Improving adverse event reporting can lead to improved safety profiles and, consequently, fewer drugs pulled from the market.
Brian Koziol
Family man, educator, mentor, athlete--and a man on a quest with Amgen Inc for new and better oncology treatments.
A Model-Based Method for Improving Protocol Quality
A new method, based on hard-earned experience, can help you reduce the risk of protocol inconsistencies and ambiguities during the protocol development process.
