title: The role of the unblinded sponsor statistician.
abstract: In clinical trials sponsored by Merck the unblinded statistician is typically an employee of the company. From a pharmaceutical industry perspective, advantages of this approach include ensuring that the unblinded statistician is knowledgeable regarding the experimental treatments, therapeutic area and study objectives; that the quality of the analysis conforms to rigorous standards; and that the allocation schedule, database and interim results are kept confidential. These advantages are felt to outweigh any potential disadvantages.
authors.affiliation: Merck Research Laboratories, BL3-2, West Point, PA 19486, USA. ssnapinn@amgen.com
authors.forename: Steven
authors.initials: S
authors.lastname: Snapinn
authors.forename: Thomas
authors.initials: T
authors.lastname: Cook
authors.forename: Deborah
authors.initials: D
authors.lastname: Shapiro
authors.forename: Duane
authors.initials: D
authors.lastname: Snavely
mesh_terms: D026661:Clinical Trials Data Monitoring Committees / Q000941:ethics* / Q000639:trends; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000592:standards; D004345:Drug Industry / Q000941:ethics* / Q000592:standards; D004995:Ethics, Professional; D005260:Female; D006801:Humans; D008297:Male; D013223:Statistics as Topic / Q000941:ethics* / Q000592:standards