Accelerating clinical development of HIV vaccine strategies: methodological challenges and considerations in constructing an optimised multi-arm phase I/II trial design

被引:0
作者
Laura Richert
Adélaïde Doussau
Jean-Daniel Lelièvre
Vincent Arnold
Véronique Rieux
Amel Bouakane
Yves Lévy
Geneviève Chêne
Rodolphe Thiébaut
机构
[1] Centre INSERM U897-Epidemiologie-Biostatistique,Université Bordeaux, ISPED
[2] Centre INSERM U897-Epidemiologie-Biostatistique,INSERM, ISPED
[3] Vaccine Research Institute (VRI),Faculté de Médecine
[4] CHU de Bordeaux,undefined
[5] Pole de sante publique,undefined
[6] INRIA SISTM,undefined
[7] INSERM U955,undefined
[8] Université Paris Est Créteil,undefined
[9] Groupe Henri-Mondor Albert-Chenevier,undefined
[10] Immunologie clinique,undefined
[11] French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS),undefined
[12] Centre INSERM U897,undefined
[13] Université Bordeaux,undefined
来源
Trials | / 15卷
关键词
Clinical trial; Design; Phase I; Phase II; Randomisation; Frequentist; Bayes; Stopping rule; Safety; HIV vaccine;
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