2020 LegalRegulatoryandPracticalIssu
- (Apostolaros et al., 2020) ⇒ Maria Apostolaros, David Babaian, Amy Corneli, Annemarie Forrest, Gerrit Hamre, Jan Hewett, Laura Podolsky, Vaishali Popat, and Penny Randall. (2020). “Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative.” In: Therapeutic Innovation & Regulatory Science Journal, 54(4).
Subject Headings: Decentralized Clinical Trial; Clinical Trials Transformation Initiative.
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Cited By
- Google Scholar: ~ 7 Citations, Retrieved: 2021-09-25.
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Author Keywords
- Mobile clinical trials; Mobile technology; Mobile medical applications; Mobile nursing; Participant-centric trials; Telehealth
Abstract
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) â a publicâprivate partnership to improve clinical trials â 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.
References
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| Author | volume | Date Value | title | type | journal | titleUrl | doi | note | year | |
|---|---|---|---|---|---|---|---|---|---|---|
| 2020 LegalRegulatoryandPracticalIssu | Maria Apostolaros David Babaian Amy Corneli Annemarie Forrest Gerrit Hamre Jan Hewett Laura Podolsky Vaishali Popat Penny Randall | Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative | 2020 |