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

Publication ,  Journal Article
Apostolaros, M; Babaian, D; Corneli, A; Forrest, A; Hamre, G; Hewett, J; Podolsky, L; Popat, V; Randall, P
Published in: Ther Innov Regul Sci
July 2020

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.

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Published In

Ther Innov Regul Sci

DOI

EISSN

2168-4804

Publication Date

July 2020

Volume

54

Issue

4

Start / End Page

779 / 787

Location

Switzerland

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Statistics & Probability
  • Research Personnel
  • Public-Private Sector Partnerships
  • Humans
  • 4905 Statistics
  • 3214 Pharmacology and pharmaceutical sciences
  • 1117 Public Health and Health Services
  • 0104 Statistics
 

Citation

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Apostolaros, M., Babaian, D., Corneli, A., Forrest, A., Hamre, G., Hewett, J., … Randall, P. (2020). Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative. Ther Innov Regul Sci, 54(4), 779–787. https://doi.org/10.1007/s43441-019-00006-4
Apostolaros, Maria, David Babaian, Amy Corneli, Annemarie Forrest, Gerrit Hamre, Jan Hewett, Laura Podolsky, Vaishali Popat, and Penny Randall. “Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative.Ther Innov Regul Sci 54, no. 4 (July 2020): 779–87. https://doi.org/10.1007/s43441-019-00006-4.
Apostolaros M, Babaian D, Corneli A, Forrest A, Hamre G, Hewett J, et al. Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative. Ther Innov Regul Sci. 2020 Jul;54(4):779–87.
Apostolaros, Maria, et al. “Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative.Ther Innov Regul Sci, vol. 54, no. 4, July 2020, pp. 779–87. Pubmed, doi:10.1007/s43441-019-00006-4.
Apostolaros M, Babaian D, Corneli A, Forrest A, Hamre G, Hewett J, Podolsky L, Popat V, Randall P. Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative. Ther Innov Regul Sci. 2020 Jul;54(4):779–787.
Journal cover image

Published In

Ther Innov Regul Sci

DOI

EISSN

2168-4804

Publication Date

July 2020

Volume

54

Issue

4

Start / End Page

779 / 787

Location

Switzerland

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Statistics & Probability
  • Research Personnel
  • Public-Private Sector Partnerships
  • Humans
  • 4905 Statistics
  • 3214 Pharmacology and pharmaceutical sciences
  • 1117 Public Health and Health Services
  • 0104 Statistics