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Combined integrated protocol/basket trial design for a first-in-human trial

BACKGROUND: Innovative trial designs are sought to streamline drug development in rare diseases. Basket- and integrated protocol designs are two of these new strategies and have been applied in a handful oncologic trials. We have taken the concept outside the realm of oncology and report about a fir...

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Detalles Bibliográficos
Autores principales: Derhaschnig, Ulla, Gilbert, Jim, Jäger, Ulrich, Böhmig, Georg, Stingl, Georg, Jilma, Bernd
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5050564/
https://www.ncbi.nlm.nih.gov/pubmed/27716293
http://dx.doi.org/10.1186/s13023-016-0494-z