Novel Clinical Trial Designs in Neuro-Oncology.
Clinical trials
Modern clinical trials
Novel trial designs
Journal
Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics
ISSN: 1878-7479
Titre abrégé: Neurotherapeutics
Pays: United States
ID NLM: 101290381
Informations de publication
Date de publication:
10 2022
10 2022
Historique:
accepted:
23
07
2022
pubmed:
16
8
2022
medline:
15
12
2022
entrez:
15
8
2022
Statut:
ppublish
Résumé
Scientific and technologic advances have led to a boon of candidate therapeutics for patients with malignancies of the central nervous system. The path from drug development to clinical use has generally followed a regimented order of sequential clinical trial phases. The recent increase in novel therapies, however, has strained the regulatory process and unearthed limitations of the current system, including significant cost, prolonged development time, and difficulties in testing therapies for rarer tumors. Novel clinical trial designs have emerged to increase efficiencies in clinical trial conduct to better evaluate and bring impactful drugs to patients in a timely manner. In order to better capture meaningful benefits for brain tumor patients, new endpoints to complement or replace traditional endpoints are also an increasingly important consideration. This review will explore the current challenges in the current clinical trial landscape and discuss novel clinical trial concepts, including consideration of limitations and risks of novel trial designs, within the context of neuro-oncology.
Identifiants
pubmed: 35969361
doi: 10.1007/s13311-022-01284-x
pii: 10.1007/s13311-022-01284-x
pmc: PMC9723049
doi:
Types de publication
Journal Article
Review
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
1844-1854Subventions
Organisme : NLM NIH HHS
ID : R01 LM013352
Pays : United States
Informations de copyright
© 2022. The American Society for Experimental Neurotherapeutics, Inc.
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