Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Nov-Dec;46(6):14-24.
doi: 10.1002/eahr.500229.

The Ethical Case for Decentralized Clinical Trials

Kathryn Muyskens  1 , Ivan Z Y Teo  2 , Jerry Menikoff  3 , G Owen Schaefer  4
Affiliations

The Ethical Case for Decentralized Clinical Trials

Kathryn Muyskens et al. Ethics Hum Res. 2024 Nov-Dec.

Abstract

The recent pandemic spurred interest in innovative design for clinical trials. In particular, constraints on the public's ability to gather led to an increase in remote or decentralized clinical trials (DCTs). DCTs present an opportunity to extend the benefits of research to underserved populations, decrease burdens, increase access to trials, and fill knowledge gaps surrounding rare conditions, though they are not without their own unique challenges and risks. These risks are far from irremediable, and the advantages are significant enough to merit attention. There is a scientific and moral case to increase the use of DCTs beyond the context of public health emergencies.

Keywords: clinical trials; decentralized clinical trials (DCTs); human subjects research; informed consent; rare diseases; research ethics.

PubMed Disclaimer

References

REFERENCES

    1. Xue, J. Z., et al., “Clinical Trial Recovery from COVID-19 Disruption,” Nature Reviews Drug Discovery 19, no. 10 (2020): 662–64.
    1. Dagliati, A., et al., “Health Informatics and EHR to Support Clinical Research in the COVID-19 Pandemic: An Overview,” Briefings in Bioinformatics 22, no. 2 (2021): 812–22; Gelinas, L., et al., “Navigating the Ethics of Remote Research Data Collection,” Clinical Trials 18, no. 5 (2021): 606-14; Li, G., et al., “Digitalized Adaptation of Oncology Trials during and after COVID-19,” Cancer Cell 38, no. 2 (2020): 148-49; Udeh-Momoh, C. T., et al., “Transition from Physical to Virtual Visit Format for a Longitudinal Brain Aging Study, in Response to the COVID-19 Pandemic. Operationalizing Adaptive Methods and Challenges,” Alzheimer's & Dementia 6, no. 1 (2020): doi:10.1002/trc2.12055; Upadhaya, S., et al., “Impact of COVID-19 on Oncology Clinical Trials,” Nature Reviews Drug Discovery 19 (2020): 376-77.
    1. Udeh-Momoh, C. T., et al., “Transition from Physical to Virtual Visit Format for a Longitudinal Brain Aging Study”; Upadhaya et al., “Impact of COVID-19 on Oncology Clinical Trials”; Rothwell, E., et al., “Informed Consent: Old and New Challenges in the Context of the COVID-19 Pandemic,” Journal of Clinical and Translational Science 5, no. 1 (2021): doi:10.1017/cts.2021.401.
    1. Dagliati et al., “Health Informatics and EHR to Support Clinical Research in the COVID-19 Pandemic”; Rothwell et al., “Informed Consent.”
    1. Dagliati, A., et al., “Health Informatics and EHR to Support Clinical Research in the COVID-19 Pandemic”; Rothwell, E., et al., “Informed Consent.”

LinkOut - more resources