title: Independence of the statistician who analyses unblinded data.
abstract: This discussion considers arguments for and against separating responsibility for the unblinded interim analysis of a clinical trial from responsibility for trial management and modifications to the ongoing trial. The degree to which one or different statisticians carry out these responsibilities and thus the degree of statistician independence for the two activities can vary, but a sponsor should recognize that giving a single statistician both responsibilities might limit flexibility in managing the trial, particularly with respect to modifying an ongoing trial.
authors.affiliation: Center for Biologics Evaluations and Research, Food and Drug Administration, Rockville, MD 20852, USA.
authors.forename: Jay P
authors.initials: JP
authors.lastname: Siegel
authors.forename: Robert T
authors.initials: RT
authors.lastname: O'Neill
authors.forename: Robert
authors.initials: R
authors.lastname: Temple
authors.forename: Gregory
authors.initials: G
authors.lastname: Campbell
authors.forename: Mary A
authors.initials: MA
authors.lastname: Foulkes
mesh_terms: D026661:Clinical Trials Data Monitoring Committees / Q000941:ethics* / Q000592:standards; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000592:standards; D003627:Data Interpretation, Statistical; D004995:Ethics, Professional; D013223:Statistics as Topic / Q000941:ethics* / Q000592:standards