Critical path activities in clinical trial setup and conduct: How to avoid bottlenecks and accelerate clinical trials.
R&D productivity
clinical trials
critical path
pharmaceutical industry
trial acceleration
Journal
Drug discovery today
ISSN: 1878-5832
Titre abrégé: Drug Discov Today
Pays: England
ID NLM: 9604391
Informations de publication
Date de publication:
10 2023
10 2023
Historique:
received:
10
03
2022
revised:
21
07
2023
accepted:
01
08
2023
medline:
23
10
2023
pubmed:
7
8
2023
entrez:
6
8
2023
Statut:
ppublish
Résumé
Most clinical trials are delayed due to scientific and/or operational challenges. Any effort to minimize delays can generate value for patients and sponsors. This article reviews critical path process steps commonly identified by practitioners, such as during protocol development, site contracting, or patient recruitment. Commonly considered measures, such as adding more trial sites or countries, were contrasted with less frequented measures, such as evidence-based feasibility or real-world evidence analysis, to help validate assumptions before clinical trial initiation. In a broad analysis, we integrated a literature review with a practitioner survey into a framework to help decision makers on the most critical process steps when setting up or conducting clinical trials in order to bring critical treatments to patients faster.
Identifiants
pubmed: 37544639
pii: S1359-6446(23)00249-0
doi: 10.1016/j.drudis.2023.103733
pii:
doi:
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
103733Informations de copyright
Copyright © 2023 Elsevier Ltd. All rights reserved.