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Substituting a randomised placebo control group with a historical placebo control in an endometriosis pain trial: a case study re-evaluating trial data using historical control data from another trial

OBJECTIVE: The substitution of an in-study control population with a historical control (HC) population is considered a viable option for reducing the necessary recruitment of control patients. However, it is necessary to evaluate whether this method is applicable to studies on indications targeting...

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Detalles Bibliográficos
Autores principales: Sieverding, Marius, Gerlinger, Christoph, Seitz, Christian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10364147/
https://www.ncbi.nlm.nih.gov/pubmed/37479520
http://dx.doi.org/10.1136/bmjopen-2022-063188