How to choose a clinical trial question? Advice from SFAR's Research Network

被引：0

作者：

Sigaut, Stephanie ^{[1
,19
,20
]}

Rolle, Amelie ^{[2
]}

Evain, Jean-Noel ^{[3
]}

Leger, Maxime ^{[4
]}

Bezu, Lucillia ^{[5
]}

Mazeraud, Aurelien ^{[6
]}

Gouel, Aurelie ^{[7
]}

Boussemart, Pierre ^{[8
]}

Jacquens, Alice ^{[9
]}

Lang, Elodie ^{[10
]}

Bouras, Marwan ^{[11
]}

Yavchitz, Amelie ^{[12
]}

Le Guen, Morgan ^{[13
]}

Kerever, Sebastien ^{[14
]}

Meuret, Ludovic ^{[15
]}

Daoui, Chafia ^{[16
]}

Beloeil, Helene ^{[17
]}

Cinotti, Raphael ^{[18
]}

机构：

[1] Hop Beaujon, AP HP, Serv Anesthesie Reanimat, Inserm UMR1141, Clichy, France

[2] Univ Guadeloupe, Ctr Hosp Univ Guadeloupe, Serv Anesthesie Pole Soins Crit, Pointe A Pitre, Guadeloupe, France

[3] Ctr Hosp Univ Grenoble Alpes, Serv Anesthesie Pediat, Pole Anesthesie Reanimat, CS 10217, Grenoble, France

[4] CHU Angers, Dept Anesthesie Reanimat, Angers, France

[5] Gustave Roussy, Dept Anesthesie Chirurg & Intervent, Serv Reanimat Polyvalente, Inserm UMR1138,Metab & Cell Biol Platforms, Villejuif, France

[6] Univ Paris Cite, Inst Pasteur, Serv Anesthesie Reanimat GHU Paris Psychiat & Neur, Pole Neuro St Anne, Paris, France

[7] Univ Paris Cite, Hop Bichat Claude Bernard, AP HP, Serv Anesthesie Reanimat, Paris, France

[8] CHU Lille, Serv Reanimat Neurochirurg, Lille, France

[9] Univ Sorbonne Paris Cite, Hop Pitie Salpetriere, AP HP, Unite Neuroanesthesie Reanimat,Inserm UMR1141 Neur, Paris, France

[10] Univ Paris Cite, AP HP, Hop Europeen Georges Pompidou, Serv Anesthesie Reanimat, F-75908 Paris, France

[11] CHU Nantes, Hotel Dieu, Serv Anesthesie Reanimat, Inserm UMR1064, F-44000 Nantes, France

[12] Hop Fdn A De Rothschild, Serv Rech Clin, Paris, France

[13] Hop Foch, Dept Anesthesie Douleur, Suresnes, France

[14] Hop Lariboisiere, AP HP, Serv Anesthesie Reanimat, Paris, France

[15] Hop Pontchaillou, CHU Rennes, Serv Anesthesie Reanimat Med Perioperatoire, Rennes, France

[16] Soc Francaise Anesthesie & Reanimat, Paris, France

[17] Univ Rennes, Univ Rennes 1, CHU Rennes, COSS 1242,CIC 1414, Rennes, France

[18] CHU Nantes, Hotel Dieu, Serv Anesthesie Reanimat, Inserm UMR1246 Sphere, Nantes, France

[19] Hop Beaujon, Serv Anesthesie Reanimat, 100 Blvd Gen Leclerc, F-92110 Clichy, France

[20] Hop Beaujon, Serv Anesthesie Reanimat, 100 Blvd Gen Leclerc, F-92110 Clichy, France

来源：

ANESTHESIE & REANIMATION | 2023年 / 9卷 / 5-6期

关键词：

Clinical research; Question; Methodology; Feasability; Research Network; SFAR;

D O I：

10.1016/j.anrea.2023.02.007

中图分类号：

R614 [麻醉学];

学科分类号：

100217 ;

摘要：

Every research project begins with a question. As its nature will influence all subsequent steps, including the methodology, the question should be clear and well-defined from the outset. This is therefore a major step in carrying out a research project, which requires expertise and work. It is indeed clinical experience and previous research that lead to a good question. For it to be relevant, it is necessary to master existing literature on the subject, to be open to new ideas, new techniques, new methodologies, imagination and creativity, as well as to pay attention to mentorship and expert advice. This question must meet criteria for feasibility, interest, novelty, ethics, and relevance (the FINER criteria). It should be formulated in a structured way to ensure maximum clarity, for example following the PICOT framework. Therefore, defining the main question of your clinical trial is not just a semantic exercise.

引用

页码：403 / 408

页数：6

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