A single center analysis of factors influencing study start-up timeline in clinical trials

AIM: Efficient start-up phase in clinical trials is crucial to execution. The goal was to determine factors contributing to delays. MATERIALS & METHODS: The start-up milestones were assessed for 38 studies and analyzed. RESULTS: Total start-up time was shorter for following studies: device trial...

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Detalles Bibliográficos
Autores principales: Krafcik, Brianna M, Doros, Gheorghe, Malikova, Marina A
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Future Science Ltd 2017
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5674216/
https://www.ncbi.nlm.nih.gov/pubmed/29134114
http://dx.doi.org/10.4155/fsoa-2017-0025
Descripción
Sumario:AIM: Efficient start-up phase in clinical trials is crucial to execution. The goal was to determine factors contributing to delays. MATERIALS & METHODS: The start-up milestones were assessed for 38 studies and analyzed. RESULTS: Total start-up time was shorter for following studies: device trials, no outsourcing, fewer ancillary services used and in interventional versus observational designs. The use of a centralized Institutional Review Board (IRB) versus a local IRB reduced time to approval. Studies that never enrolled took longer on average to finalize their budget/contract, and obtain IRB than ones that did enroll. CONCLUSION: Different features of clinical trials can affect timeline of start-up process. An understanding of the impact of each feature allows for optimization.

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