Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative.
Mobile clinical trials
Mobile medical applications
Mobile nursing
Mobile technology
Participant-centric trials
Telehealth
Journal
Therapeutic innovation & regulatory science
ISSN: 2168-4804
Titre abrégé: Ther Innov Regul Sci
Pays: Switzerland
ID NLM: 101597411
Informations de publication
Date de publication:
07 2020
07 2020
Historique:
received:
20
05
2019
accepted:
17
09
2019
entrez:
20
6
2020
pubmed:
20
6
2020
medline:
29
5
2021
Statut:
ppublish
Résumé
Traditional clinical trials are often expensive, inefficient, include selected populations, and can create significant participant burden via travel and other logistical demands. Using new technologies and methodologies to promote a decentralized approach has the potential to improve the efficiency of clinical trials. The Clinical Trials Transformation Initiative (CTTI)-a public-private partnership to improve clinical trials-launched a multi-stakeholder Decentralized Clinical Trials (DCTs) Project to provide recommendations on addressing the actual and perceived legal, regulatory, and practical challenges with DCT design and conduct in the United States. Informed by qualitative group interviews and an expert meeting, CTTI engaged stakeholders to identify key challenges to implementing DCTs and possible solutions. The CTTI DCT project team used the interview findings and expert feedback to develop recommendations that will drive broader use of DCTs. CTTI's recommendations cover protocol design, use of telemedicine and mobile healthcare providers, medical product supply chain, investigator delegation and oversight, and safety monitoring considerations. By implementing these recommendations, sponsors, contract research organizations, and others can help advance successful medical product development using mobile technologies and methodologies in DCTs.
Sections du résumé
BACKGROUND
Traditional clinical trials are often expensive, inefficient, include selected populations, and can create significant participant burden via travel and other logistical demands. Using new technologies and methodologies to promote a decentralized approach has the potential to improve the efficiency of clinical trials. The Clinical Trials Transformation Initiative (CTTI)-a public-private partnership to improve clinical trials-launched a multi-stakeholder Decentralized Clinical Trials (DCTs) Project to provide recommendations on addressing the actual and perceived legal, regulatory, and practical challenges with DCT design and conduct in the United States.
METHODS
Informed by qualitative group interviews and an expert meeting, CTTI engaged stakeholders to identify key challenges to implementing DCTs and possible solutions.
RESULTS
The CTTI DCT project team used the interview findings and expert feedback to develop recommendations that will drive broader use of DCTs.
CONCLUSIONS
CTTI's recommendations cover protocol design, use of telemedicine and mobile healthcare providers, medical product supply chain, investigator delegation and oversight, and safety monitoring considerations. By implementing these recommendations, sponsors, contract research organizations, and others can help advance successful medical product development using mobile technologies and methodologies in DCTs.
Identifiants
pubmed: 32557302
doi: 10.1007/s43441-019-00006-4
pii: 10.1007/s43441-019-00006-4
pmc: PMC7362888
doi:
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, U.S. Gov't, Non-P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
779-787Références
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