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Platform trials.
Roustit, Matthieu; Demarcq, Olivier; Laporte, Silvy; Barthélémy, Philippe; Chassany, Olivier; Cucherat, Michel; Demotes, Jacques; Diebolt, Vincent; Espérou, Hélène; Fouret, Cécile; Galaup, Ariane; Gambotti, Laetitia; Gourio, Charlotte; Guérin, Aurélie; Labruyère, Carine; Paoletti, Xavier; Porcher, Raphael; Simon, Tabassome; Varoqueaux, Nathalie.
Afiliação
  • Roustit M; Inserm CIC1406, university Grenoble Alpes, CHU de Grenoble, 38000 Grenoble, France. Electronic address: MRoustit@chu-grenoble.fr.
  • Demarcq O; Pfizer, direction des affaires médicales, 75668 Paris, France.
  • Laporte S; Inserm, U 1059 Sainbiose, Mines Saint-Étienne, unité de recherche clinique, innovation, pharmacologie, université Jean Monnet, CHU de Saint-Étienne, 42023 Saint-Étienne, France.
  • Barthélémy P; AstraZeneca, direction recherche clinique, 92400 Courbevoie, France.
  • Chassany O; Unité de recherche clinique en économie de la santé (URC-ECO), hôpital Hôtel-Dieu, AP-HP, 75004 Paris, France.
  • Cucherat M; metaEvidence.org, service hospitalo-universitaire de pharmacologie et toxicologie, hospices civils de Lyon, 69000 Lyon, France.
  • Demotes J; ECRIN, 75013 Paris, France.
  • Diebolt V; F-CRIN, UMS 015, Pavillon Leriche, hôpital Purpan/CHU de Toulouse, 31059 Toulouse, France.
  • Espérou H; Inserm, pôle de recherche clinique, Institut de santé publique, 75013 Paris, France.
  • Fouret C; Medtronic, direction des affaires scientifiques, 75014 Paris, France.
  • Galaup A; Leem, 75017 Paris, France.
  • Gambotti L; Département recherche clinique, Institut national du cancer, 92100 Boulogne-Billancourt, France.
  • Gourio C; CHU de Caen, 14033 Caen, France.
  • Guérin A; Pfizer, recherche clinique, 75668 Paris, France.
  • Labruyère C; Inserm, U 1059 Sainbiose, Mines Saint-Étienne, unité de recherche clinique, innovation, pharmacologie, université Jean Monnet, CHU de Saint-Étienne, 42023 Saint-Étienne, France.
  • Paoletti X; Inserm U900, équipe de statistique pour la médecine de précision (STAMPM), Institut Curie, université de Versailles St Quentin/Paris-Saclay, 92210 St-Cloud, France.
  • Porcher R; Inserm, Inra, centre d'épidémiologie clinique, université Paris Cité, METHODS Team, CRESS, Hôtel-Dieu, Assistance publique-Hôpitaux de Paris, 75004 Paris, France.
  • Simon T; Service de pharmacologie, plateforme de recherche clinique de l'Est parisien, Sorbonne université, Assistance publique-Hôpitaux de Paris, 75012 Paris, France.
  • Varoqueaux N; Amgen, direction des affaires médicales, 92100 Boulogne-Billancourt, France.
Therapie ; 78(1): 29-38, 2023.
Article em En | MEDLINE | ID: mdl-36529559
ABSTRACT
For the past few years, platform trials have experienced a significant increase, recently amplified by the COVID-19 pandemic. The implementation of a platform trial is particularly useful in certain pathologies, particularly when there is a significant number of drug candidates to be assessed, a rapid evolution of the standard of care or in situations of urgent need for evaluation, during which the pooling of protocols and infrastructure optimizes the number of patients to be enrolled, the costs, and the deadlines for carrying out the investigation. However, the specificity of platform trials raises methodological, ethical, and regulatory issues, which have been the subject of the round table and which are presented in this article. The round table was also an opportunity to discuss the complexity of sponsorship and data management related to the multiplicity of partners, funding, and governance of these trials, and the level of acceptability of their findings by the competent authorities.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Ensaios Clínicos Controlados Aleatórios como Assunto / Ensaios Clínicos Adaptados como Assunto Limite: Humans Idioma: En Revista: Therapie Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Ensaios Clínicos Controlados Aleatórios como Assunto / Ensaios Clínicos Adaptados como Assunto Limite: Humans Idioma: En Revista: Therapie Ano de publicação: 2023 Tipo de documento: Article