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
. 2021 Apr 27;6(4):384-387.
doi: 10.1016/j.jacbts.2021.01.011. eCollection 2021 Apr.

Decentralized Clinical Trials: The Future of Medical Product Development?∗

Gail A Van Norman  1
Affiliations

Decentralized Clinical Trials: The Future of Medical Product Development?∗

Gail A Van Norman. JACC Basic Transl Sci. .
No abstract available

Keywords: COVID-19; blockchain; decentralized clinical trials; drug development; virtual clinical trials.

PubMed Disclaimer

Conflict of interest statement

Dr. Van Norman has received funding from the American College of Cardiology for this publication.

Figures

None
Graphical abstract
Central Illustration
Central Illustration
Decentralized Clinical Trials In decentralized clinical trials, patient visits for healthcare provider interaction and laboratory tests are localized in the patient’s community. Medications for the study are provided either directly to the patient or the local healthcare facility. Other interactions, including patient recruitment and monitoring occur via internet interactions, with data secured and maintained virtually.
See this image and copyright information in PMC

References

    1. Khozin S., Coravox A. Decentralized trials in the age of real-world evidence and inclusivity in clinical investigations. Clin Pharmacol Ther. 2019;106:25–27. - PubMed
    1. Agbo C.C., Mahmoud Q.H., Eklund J.M. Blockchain technology in healthcare: a systematic review. Healthcare. 2019;7:56. - PMC - PubMed
    1. Orri M., Lispet C.H., Jacobs B.P. Web-based trial to evaluate the efficacy and safety of tolterodine ER 4 mg in participants with overactive bladder: REMOTE trial. Contemp Clin Trials. 2014;38:190–197. - PubMed
    1. Clinical Trials Transformation Initiative CTTI recommendations: decentralized clinical trials. September 2018. https://www.ctti-clinicaltrials.org/sites/www.ctti-clinicaltrials.org/fi... Available at:
    1. U.S. Food and Drug Administration FDA guidance on conduct of clinical trials of medical products during COVID-19 public health emergency. https://www.fda.gov/regulatory-information/search-fda-guidance-documents... Available at:

LinkOut - more resources