2019
DOI: 10.1007/s43441-019-00006-4
|View full text |Cite
|
Sign up to set email alerts
|

Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative

Abstract: 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 t… Show more

Help me understand this report

Search citation statements

Order By: Relevance

Paper Sections

Select...
2
1

Citation Types

0
167
0

Year Published

2020
2020
2024
2024

Publication Types

Select...
8

Relationship

0
8

Authors

Journals

citations
Cited by 77 publications
(173 citation statements)
references
References 12 publications
0
167
0
Order By: Relevance
“…The opportunity for remote clinical trials has been recognized for some time and the industry is making inroads into this operational paradigm 3 . The current pandemic, and the possible recurrence, have increased demand for remote trials and solutions for preserving trial integrity during the pandemic are being proposed 4 .…”
Section: Figurementioning
confidence: 99%
See 1 more Smart Citation
“…The opportunity for remote clinical trials has been recognized for some time and the industry is making inroads into this operational paradigm 3 . The current pandemic, and the possible recurrence, have increased demand for remote trials and solutions for preserving trial integrity during the pandemic are being proposed 4 .…”
Section: Figurementioning
confidence: 99%
“…The progress of adopting a decentralized clinical trial model and remote data collection was limited prior to the COVID‐19 pandemic 3 . However, the rapid adoption of telehealth during COVID‐19 when remote doctor visits became vital and, in many instances, the only option for healthcare delivery demonstrated that many barriers can be removed within a matter of weeks 8 .…”
Section: Figurementioning
confidence: 99%
“…The FDA guidance provides detailed recommendations for remote/virtual assessments, including considerations for remote data collection. The distant operation of clinical trials has been proposed as a model to reduce participant burden and increased logistical demands [12]. The use of telemedicine and mobile healthcare providers, medical product supply chain, investigator delegation and oversight, and safety monitoring considerations has been increasingly advocated as a model to decentralize clinical trials (DTCs) [12].…”
Section: Discussionmentioning
confidence: 99%
“…Lastly, researchers should focus on innovative ways to collect biospecimens remotely and push for the adoption of more decentralized clinical trials. 9 As technologies improve, this will undoubtedly be an area with significant capacity to change the way clinical trials are conducted.…”
mentioning
confidence: 99%
“…These partnerships and investments also will help to build trust within rural communities, and they may help to bridge the gap between local providers and researchers. Lastly, researchers should focus on innovative ways to collect biospecimens remotely and push for the adoption of more decentralized clinical trials 9 . As technologies improve, this will undoubtedly be an area with significant capacity to change the way clinical trials are conducted.…”
mentioning
confidence: 99%