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Randomized Controlled Trial
. 2020 Jul;54(4):779-787.
doi: 10.1007/s43441-019-00006-4. Epub 2019 Dec 9.

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

Maria Apostolaros  1 , David Babaian  2 , Amy Corneli  3   4 , Annemarie Forrest  5 , Gerrit Hamre  6 , Jan Hewett  7 , Laura Podolsky  8 , Vaishali Popat  9 , Penny Randall  10
Affiliations
Randomized Controlled Trial

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

Maria Apostolaros et al. Ther Innov Regul Sci. 2020 Jul.

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 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.

Keywords: Mobile clinical trials; Mobile medical applications; Mobile nursing; Mobile technology; Participant-centric trials; Telehealth.

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Conflict of interest statement

The authors declared that they have no conflicts of interest.

References

    1. Internet/Broadband Fact Sheet. Pew Research Center.
    1. Thomas L, Capistrant G. 50 State telemedicine gaps analysis: physician practice standards and licensure. Washington DC: American Telemedicine Association; 2017.
    1. Center for Connected Health Policy. State Telehealth Laws and Reimbursement Policies: a comprehensive scan of the 50 states and the district of Columbia. Public Health Institute; 2018.
    1. Clinical Trials Transformation Initiative. Program: Mobile Clinical Trials (MCT). Clinical Trials Transformation Initiative.
    1. Patton MQ. Qualitative research and evaluation methods. 3. Thousand Oaks, CA: Sage; 2002.

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