@article{16165,
  keywords = {Humans, Randomised Controlled Trials, Treatment Outcome, Apache, Placebos, Questionnaires, Research Design, United States Food and Drug Administration, United States, Protein C, Therapeutic use, Clinical Trials, Multicenter Studies as Topic, Recombinant Proteins, Anti-Infective Agents, Septic Shock, Drug Industry, Ethics},
  author = {Barie P. and Douglas I. and Gardlund B. and Finfer Simon and Ranieri V. and Rhodes A. and Thompson B. and Marshall J. and Dhainaut J.},
  title = {Design, conduct, analysis and reporting of a multi-national placebo-controlled trial of activated protein C for persistent septic shock},
  abstract = {<p>
The role of drotrecogin alfa (activated) (DAA) in severe sepsis remains controversial and clinicians are unsure whether or not to treat their patients with DAA. In response to a request from the European Medicines Agency, Eli Lilly will sponsor a new placebo-controlled trial and history suggests the results will be subject to great scrutiny. An academic steering committee will oversee the conduct of the study and will write the study manuscripts. The steering committee intends that the study will be conducted with the maximum possible transparency; this includes publication of the study protocol and a memorandum of understanding which delineates the role of the sponsor. The trial has the potential to provide clinicians with valuable data but patients will only benefit if clinicians have confidence in the conduct, analysis and reporting of the trial. This special article describes the process by which the trial was developed, major decisions regarding trial design, and plans for independent analysis, interpretation and reporting of the data.
</p>
},
  year = {2008},
  journal = {Intensive Care Medicine},
  volume = {34},
  edition = {2008/10/08},
  number = {11},
  pages = {1935-47},
  month = {128306597146},
  isbn = {0342-4642 (Print)0342-4642 (Linking)},
  note = {Finfer, SimonRanieri, V MarcoThompson, B TaylorBarie, Philip SDhainaut, Jean-FrancoisDouglas, Ivor SGardlund, BengtMarshall, John CRhodes, AndrewUnited StatesIntensive Care Med. 2008 Nov;34(11):1935-47. Epub 2008 Oct 7.},
  language = {eng},
}