title: Off-protocol access to study therapies.
abstract: The ethics of allowing off-protocol access to a study therapy are explored, using the example of recombinant factor VIIa for intracerebral hemorrhage. rVIIa was later found to be ineffective. While the studies were being performed, researchers struggled with the question of whether a critically ill patient with intracerebral hemorrhage was actually indifferent between the treatment and placebo arms of the trial.
authors: Department of Neurology, Brigham and Women's Hospital, Boston, MA, USA.
authors: Thomas I
authors: TI
authors: Cochrane
mesh_terms: D002543:Cerebral Hemorrhage / Q000188:drug therapy*; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000379:methods; D015942:Factor VIIa / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D056687:Off-Label Use / Q000941:ethics*; D011994:Recombinant Proteins / Q000627:therapeutic use
chemical_list: D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa