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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.
AuthorsThomas I Cochrane
JournalTopics in stroke rehabilitation (Top Stroke Rehabil) 2013 Jan-Feb Vol. 20 Issue 1 Pg. 1-4 ISSN: 1074-9357 [Print] England
PMID23340066 (Publication Type: Case Reports, Journal Article)
Chemical References
  • Recombinant Proteins
  • recombinant FVIIa
  • Factor VIIa
Topics
  • Cerebral Hemorrhage (drug therapy)
  • Clinical Trials as Topic (ethics, methods)
  • Factor VIIa (therapeutic use)
  • Humans
  • Male
  • Middle Aged
  • Off-Label Use (ethics)
  • Recombinant Proteins (therapeutic use)

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