Leveraging the Expertise of the CTSA Program to Increase the Impact and Efficiency of Clinical Trials.
Journal
JAMA network open
ISSN: 2574-3805
Titre abrégé: JAMA Netw Open
Pays: United States
ID NLM: 101729235
Informations de publication
Date de publication:
02 10 2023
02 10 2023
Historique:
medline:
6
10
2023
pubmed:
5
10
2023
entrez:
5
10
2023
Statut:
epublish
Résumé
Multicenter clinical trials play a critical role in the translational processes that enable new treatments to reach all people and improve public health. However, conducting multicenter randomized clinical trials (mRCT) presents challenges. The Trial Innovation Network (TIN), established in 2016 to partner with the Clinical and Translational Science Award (CTSA) Consortium of academic medical institutions in the implementation of mRCTs, consists of 3 Trial Innovation Centers (TICs) and 1 Recruitment Innovation Center (RIC). This unique partnership has aimed to address critical roadblocks that impede the design and conduct of mRCTs, in expectation of accelerating the translation of novel interventions to clinical practice. The TIN's challenges and achievements are described in this article, along with examples of innovative resources and processes that may serve as useful models for other clinical trial networks providing operational and recruitment support. The TIN has successfully integrated more than 60 CTSA institution program hubs into a functional network for mRCT implementation and optimization. A unique support system for investigators has been created that includes the development and deployment of novel tools, operational and recruitment services, consultation models, and rapid communication pathways designed to reduce delays in trial start-up, enhance recruitment, improve engagement of diverse research participants and communities, and streamline processes that improve the quality, efficiency, and conduct of mRCTs. These resources and processes span the clinical trial spectrum and enable the TICs and RIC to serve as coordinating centers, data centers, and recruitment specialists to assist trials across the National Institutes of Health and other agencies. The TIN's impact has been demonstrated through its response to both historical operational challenges and emerging public health emergencies, including the national opioid public health crisis and the COVID-19 pandemic. The TIN has worked to reduce barriers to implementing mRCTs and to improve mRCT processes and operations by providing needed clinical trial infrastructure and resources to CTSA investigators. These resources have been instrumental in more quickly and efficiently translating research discoveries into beneficial patient treatments.
Identifiants
pubmed: 37796498
pii: 2810186
doi: 10.1001/jamanetworkopen.2023.36470
doi:
Types de publication
Multicenter Study
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
e2336470Subventions
Organisme : NCATS NIH HHS
ID : U24 TR001597
Pays : United States
Organisme : NCATS NIH HHS
ID : U24 TR001608
Pays : United States
Organisme : NCATS NIH HHS
ID : U24 TR001609
Pays : United States
Organisme : NCATS NIH HHS
ID : U24 TR001579
Pays : United States
Investigateurs
Rachel Greenberg
(R)
Kanecia Zimmerman
(K)
Brian Smith
(B)
Frank Rockhold
(F)
Lori Poole
(L)
Jesse Hickerson
(J)
Eilene Pham
(E)
Eve Marion
(E)
Helen Boyle
(H)
Vincent Miller
(V)
Sonya Sutton
(S)
Michelle Jones
(M)
Princess Abbott-Grimes
(P)
Nichole McBee
(N)
Andrew Mould
(A)
Lindsay Eyzaguirre
(L)
Megan Singleton
(M)
Janelle Maddox-Regis
(J)
Shannon Hillery
(S)
Angeline Nanni
(A)
Meghan Hildreth
(M)
Cecilia Pessoa-Gingerish
(C)
Emily Bartlett
(E)
Theodora Cohen
(T)
Cortney Wieber
(C)
Krista Vermillion
(K)
Erin Rothwell
(E)
Kevin Watt
(K)
Kathy Sward
(K)
John M VanBuren
(JM)
Mary Pautler
(M)
Marie Kay
(M)
Jordan Bridges
(J)
Krista Ellis
(K)
Francis Sebahar
(F)
Eun Hea Unsicker
(EH)
Valeriya Vasenina
(V)
Talmage Morris
(T)
Michelle Aponte
(M)
Ann Johnson
(A)
Annie Risenmay
(A)
Lisa Rigtrup
(L)
Gary Henderson
(G)
Ammon Leon Pate
(AL)
Monse Lopez
(M)
Leslie Boone
(L)
Loretta Byrne
(L)
Tara Helmer
(T)
Maeve Tischbein
(M)
Leah Dunkel
(L)
Stephanie Mayers
(S)
Kaysi Quarles
(K)
Jasmine Bell
(J)
Bridget Swindell
(B)
Jabari Ichimura
(J)
Devan Ray
(D)
Caitlin Rantala
(C)
Jessica Eidenmuller
(J)
Emily Serdoz
(E)
Natalie Dilts
(N)
David Crenshaw
(D)
Brooklyn Henderson
(B)
Meghan Vance
(M)
Delicia Burts
(D)
Dione Grant
(D)
Jahi Hamilton
(J)
Matt Schorr
(M)
Colleen Lawrence
(C)
Meredith Bernui
(M)
Taylor Budine
(T)
Amna Baig
(A)
Joseph Christodoulou
(J)
Jodie Cohen
(J)
Tiffany Chen
(T)
Julia Dunagan
(J)
Wendy Lloyd
(W)
Commentaires et corrections
Type : CommentIn
Type : ErratumIn