Building an infrastructure to support the development, conduct, and reporting of informative clinical studies: The Rockefeller University experience.
CTSA
Clinical trials
metrics
translational research
translational science
Journal
Journal of clinical and translational science
ISSN: 2059-8661
Titre abrégé: J Clin Transl Sci
Pays: England
ID NLM: 101689953
Informations de publication
Date de publication:
2023
2023
Historique:
received:
31
01
2023
accepted:
30
03
2023
medline:
30
5
2023
pubmed:
30
5
2023
entrez:
30
5
2023
Statut:
epublish
Résumé
Clinical trials are a vital component of translational science, providing crucial information on the efficacy and safety of new interventions and forming the basis for regulatory approval and/or clinical adoption. At the same time, they are complex to design, conduct, monitor, and report successfully. Concerns over the last two decades about the quality of the design and the lack of completion and reporting of clinical trials, characterized as a lack of "informativeness," highlighted by the experience during the COVID-19 pandemic, have led to several initiatives to address the serious shortcomings of the United States clinical research enterprise. Against this background, we detail the policies, procedures, and programs that we have developed in The Rockefeller University Center for Clinical and Translational Science (CCTS), supported by a Clinical and Translational Science Award (CTSA) program grant since 2006, to support the development, conduct, and reporting of informative clinical studies. We have focused on building a data-driven infrastructure to both assist individual investigators and bring translational science to each element of the clinical investigation process, with the goal of both generating new knowledge and accelerating the uptake of that knowledge into practice.
Identifiants
pubmed: 37250985
doi: 10.1017/cts.2023.521
pii: S2059866123005216
pmc: PMC10225266
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e104Subventions
Organisme : NCATS NIH HHS
ID : UL1 TR001866
Pays : United States
Informations de copyright
© The Author(s) 2023.
Déclaration de conflit d'intérêts
A dedicated university counsel oversees clinical trial contracting, material transfer agreements, and the university’s conflict of interest program. She serves on both the ACCTS and the IRB, facilitating the flow of information on both topics to the appropriate committees.The authors have no disclosures to declare.
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