Design, conduct, analysis and reporting of a multi-national placebo-controlled trial of activated protein C for persistent septic shock. Commentary
Identifieur interne : 008D99 ( Main/Exploration ); précédent : 008D98; suivant : 008E00Design, conduct, analysis and reporting of a multi-national placebo-controlled trial of activated protein C for persistent septic shock. Commentary
Auteurs : Simon Finfer [Australie] ; V. Marco Ranieri [Italie] ; B. Taylor Thompson [États-Unis] ; Philip S. Barie [États-Unis] ; Jean-Francois Dhainaut [France] ; Ivor S. Douglas [États-Unis] ; Bengt Gardlund [Suède] ; John C. Marshall [Canada] ; Andrew Rhodes [Royaume-Uni] ; Jordi Mancebo [Espagne] ; Massimo Antonelli [Italie]Source :
- Intensive care medicine : (Print) [ 0342-4642 ] ; 2008.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
Abstract
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.
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Affiliations:
- Australie, Canada, Espagne, France, Italie, Royaume-Uni, Suède, États-Unis
- Catalogne, Latium, Nouvelle-Galles du Sud, Piémont, Svealand, Île-de-France
- Paris, Rome, Stockholm, Sydney, Turin
- Université de Sydney
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Le document en format XML
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Giovanni Battista-Molinette, Università di Torino</s1><s2>Torino</s2><s3>ITA</s3><sZ>2 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Turin</settlement><region type="région" nuts="2">Piémont</region></placeName></affiliation></author><author><name sortKey="Thompson, B Taylor" sort="Thompson, B Taylor" uniqKey="Thompson B" first="B. Taylor" last="Thompson">B. Taylor Thompson</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Pulmonary and Critical Care Unit, Bullfinch Building, Room 148, Massachusetts General Hospital, 55 Fruit Street</s1><s2>Boston, MA 02114</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Boston, MA 02114</wicri:noRegion></affiliation></author><author><name sortKey="Barie, Philip S" sort="Barie, Philip S" uniqKey="Barie P" first="Philip S." last="Barie">Philip S. Barie</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Department of Surgery, P713A, Weill Cornell Medical College, 525 East 68 St</s1><s2>New York, NY 10065</s2><s3>USA</s3><sZ>4 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>New York, NY 10065</wicri:noRegion></affiliation></author><author><name sortKey="Dhainaut, Jean Francois" sort="Dhainaut, Jean Francois" uniqKey="Dhainaut J" first="Jean-Francois" last="Dhainaut">Jean-Francois Dhainaut</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Cochin Port Royal Hospital-Paris Descartes University</s1><s2>Paris</s2><s3>FRA</s3><sZ>5 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Douglas, Ivor S" sort="Douglas, Ivor S" uniqKey="Douglas I" first="Ivor S." last="Douglas">Ivor S. Douglas</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Denver Health and University of Colorado</s1><s2>Denver</s2><s3>USA</s3><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Denver Health and University of Colorado</wicri:noRegion></affiliation></author><author><name sortKey="Gardlund, Bengt" sort="Gardlund, Bengt" uniqKey="Gardlund B" first="Bengt" last="Gardlund">Bengt Gardlund</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Department of Infectious Diseases, Karolinska University Hospital</s1><s2>14186 Stockholm</s2><s3>SWE</s3><sZ>7 aut.</sZ></inist:fA14><country>Suède</country><placeName><settlement type="city">Stockholm</settlement><region nuts="2">Svealand</region></placeName></affiliation></author><author><name sortKey="Marshall, John C" sort="Marshall, John C" uniqKey="Marshall J" first="John C." last="Marshall">John C. Marshall</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Departments of Surgery and Critical Care Medicine, St Michael's Hospital, 4th Floor Bond Wing, Rm. 4-007, 30 Bond Street</s1><s2>Toronto, ON M5B 1W8</s2><s3>CAN</s3><sZ>8 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>Toronto, ON M5B 1W8</wicri:noRegion></affiliation></author><author><name sortKey="Rhodes, Andrew" sort="Rhodes, Andrew" uniqKey="Rhodes A" first="Andrew" last="Rhodes">Andrew Rhodes</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Department of Intensive Care Medicine and Anaesthesia, St George's Hospital</s1><s2>London SW17 OQT</s2><s3>GBR</s3><sZ>9 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>London SW17 OQT</wicri:noRegion></affiliation></author><author><name sortKey="Mancebo, Jordi" sort="Mancebo, Jordi" uniqKey="Mancebo J" first="Jordi" last="Mancebo">Jordi Mancebo</name><affiliation wicri:level="2"><inist:fA14 i1="10"><s1>Servei de Medicina Intensiva, Hospital de Sant Pau, Av. S.A.M. Claret 167</s1><s2>08025 Barcelona</s2><s3>ESP</s3><sZ>10 aut.</sZ></inist:fA14><country>Espagne</country><placeName><region nuts="2" type="communauté">Catalogne</region></placeName></affiliation></author><author><name sortKey="Antonelli, Massimo" sort="Antonelli, Massimo" uniqKey="Antonelli M" first="Massimo" last="Antonelli">Massimo Antonelli</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Department of Intensive Care and Anesthesiology, Policlinico Universitario A. Gemelli, Università Cattolica del Sacro Cuore, Largo A. Gemelli, 8</s1><s2>00168 Rome</s2><s3>ITA</s3><sZ>11 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Rome</settlement><region nuts="2">Latium</region></placeName></affiliation></author></analytic><series><title level="j" type="main">Intensive care medicine : (Print)</title><title level="j" type="abbreviated">Intensive care med. : (Print)</title><idno type="ISSN">0342-4642</idno><imprint><date when="2008">2008</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Intensive care medicine : (Print)</title><title level="j" type="abbreviated">Intensive care med. : (Print)</title><idno type="ISSN">0342-4642</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Drotrecogin alfa (activated)</term><term>Ethics</term><term>Industry</term><term>Infection</term><term>Intensive care</term><term>Methodology</term><term>Protein C (activated)</term><term>Resuscitation</term><term>Sepsis syndrome</term><term>Shock</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Infection</term><term>Choc</term><term>Syndrome septique</term><term>Protein C (activated)</term><term>Drotrécogine alfa (activé)</term><term>Méthodologie</term><term>Industrie</term><term>Ethique</term><term>Réanimation</term><term>Soin intensif</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">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.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Canada</li><li>Espagne</li><li>France</li><li>Italie</li><li>Royaume-Uni</li><li>Suède</li><li>États-Unis</li></country><region><li>Catalogne</li><li>Latium</li><li>Nouvelle-Galles du Sud</li><li>Piémont</li><li>Svealand</li><li>Île-de-France</li></region><settlement><li>Paris</li><li>Rome</li><li>Stockholm</li><li>Sydney</li><li>Turin</li></settlement><orgName><li>Université de Sydney</li></orgName></list><tree><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Finfer, Simon" sort="Finfer, Simon" uniqKey="Finfer S" first="Simon" last="Finfer">Simon Finfer</name></region></country><country name="Italie"><region name="Piémont"><name sortKey="Marco Ranieri, V" sort="Marco Ranieri, V" uniqKey="Marco Ranieri V" first="V." last="Marco Ranieri">V. Marco Ranieri</name></region><name sortKey="Antonelli, Massimo" sort="Antonelli, Massimo" uniqKey="Antonelli M" first="Massimo" last="Antonelli">Massimo Antonelli</name></country><country name="États-Unis"><noRegion><name sortKey="Thompson, B Taylor" sort="Thompson, B Taylor" uniqKey="Thompson B" first="B. Taylor" last="Thompson">B. Taylor Thompson</name></noRegion><name sortKey="Barie, Philip S" sort="Barie, Philip S" uniqKey="Barie P" first="Philip S." last="Barie">Philip S. Barie</name><name sortKey="Douglas, Ivor S" sort="Douglas, Ivor S" uniqKey="Douglas I" first="Ivor S." last="Douglas">Ivor S. Douglas</name></country><country name="France"><region name="Île-de-France"><name sortKey="Dhainaut, Jean Francois" sort="Dhainaut, Jean Francois" uniqKey="Dhainaut J" first="Jean-Francois" last="Dhainaut">Jean-Francois Dhainaut</name></region></country><country name="Suède"><region name="Svealand"><name sortKey="Gardlund, Bengt" sort="Gardlund, Bengt" uniqKey="Gardlund B" first="Bengt" last="Gardlund">Bengt Gardlund</name></region></country><country name="Canada"><noRegion><name sortKey="Marshall, John C" sort="Marshall, John C" uniqKey="Marshall J" first="John C." last="Marshall">John C. Marshall</name></noRegion></country><country name="Royaume-Uni"><noRegion><name sortKey="Rhodes, Andrew" sort="Rhodes, Andrew" uniqKey="Rhodes A" first="Andrew" last="Rhodes">Andrew Rhodes</name></noRegion></country><country name="Espagne"><region name="Catalogne"><name sortKey="Mancebo, Jordi" sort="Mancebo, Jordi" uniqKey="Mancebo J" first="Jordi" last="Mancebo">Jordi Mancebo</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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