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.
AD - Critical Care and Trauma, The George Institute for International Health, University of Sydney, Sydney, NSW, Australia. sfinfer@george.org.au AN - 18839141 BT - Intensive Care Medicine C2 - 2995439 DA - 128306597146 DP - NLM ET - 2008/10/08 J2 - Intensive care medicine LA - eng M1 - 11 N1 - 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. N2 -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.
PY - 2008 SN - 0342-4642 (Print)0342-4642 (Linking) SP - 1935 EP - 47 ST - Intensive Care Med.Intensive Care Med. T2 - Intensive Care Medicine TI - Design, conduct, analysis and reporting of a multi-national placebo-controlled trial of activated protein C for persistent septic shock VL - 34 ER -