Preparing clinicians to be site investigators in multicenter clinical trials: A training program at an academic medical center.
Education
capacity building
clinical trial
program
research personnel
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:
24
03
2023
revised:
16
06
2023
accepted:
28
06
2023
medline:
17
8
2023
pubmed:
17
8
2023
entrez:
17
8
2023
Statut:
epublish
Résumé
Clinical trials are essential in the translation of biomedical discoveries to new clinical interventions and therapeutics. Successful multisite clinical trials require qualified site investigators with an understanding of the full spectrum of processes and requirements from trial identification through closeout. New site investigators may be deterred by competing demands on their time, the complexity of administrative and regulatory processes for trial initiation and conduct, and limited access to experienced mentor networks. We established a Clinical Trialist Training Program (CTTP) and complimentary Clinical Trials Bootcamp at our institution to address these barriers and increase the number of local site investigators enabled to lead successful clinical trials. An initial cohort of four CTTP scholars received salary support with protected time, didactic training, assistance with study identification and start-up navigation, and quarterly progress meetings. By the end of the 12-month program, this initial cohort identified 33 new trials, utilized feasibility assessments, and reported being on target to sustain their protected time from new clinical trials. Bootcamp attendees demonstrated increased knowledge of resources, offices, and processes associated with clinical trial conduct. Our results support providing compensated protected time, training, and access to experienced clinical research professionals to enable clinicians to become successful site investigators.
Identifiants
pubmed: 37588676
doi: 10.1017/cts.2023.587
pii: S2059866123005873
pmc: PMC10425868
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e167Subventions
Organisme : NCATS NIH HHS
ID : UL1 TR001450
Pays : United States
Informations de copyright
© The Author(s) 2023.
Déclaration de conflit d'intérêts
The authors have no conflicts of interest to report.
Références
Contemp Clin Trials Commun. 2018 Aug 07;11:156-164
pubmed: 30112460
J Empir Res Hum Res Ethics. 2018 Apr;13(2):139-144
pubmed: 29345179
J Clin Transl Sci. 2017 Feb;1(1):16-25
pubmed: 28480054
J Vasc Interv Neurol. 2008 Jan;1(1):31
pubmed: 22518214
Contemp Clin Trials Commun. 2017 Mar 08;6:31-38
pubmed: 29740635
J Biomed Inform. 2019 Jul;95:103208
pubmed: 31078660
Clin Trials. 2012 Jun;9(3):367-9
pubmed: 22692806
Clin Res (Alex). 2018;32(3):
pubmed: 30613763
Acad Med. 2011 Nov;86(11):1360-6
pubmed: 21952064
J Am Med Inform Assoc. 2021 Jul 14;28(7):1440-1450
pubmed: 33729486
Ochsner J. 2020 Spring;20(1):44-49
pubmed: 32284682
J Biomed Inform. 2009 Apr;42(2):377-81
pubmed: 18929686
J Clin Oncol. 2006 Oct 1;24(28):4545-52
pubmed: 17008693
Ther Innov Regul Sci. 2018 Sep;52(5):572-578
pubmed: 29714558
J Clin Transl Sci. 2022 Apr 01;6(1):e63
pubmed: 35720964
Contemp Clin Trials Commun. 2020 Mar 17;18:100557
pubmed: 32258818
J Clin Transl Sci. 2021 Nov 10;6(1):e8
pubmed: 35211334
J Clin Transl Sci. 2023 Feb 08;7(1):e63
pubmed: 37008607