Prototype of running clinical trials in an untrustworthy environment using blockchain

Nature Communications
Daniel R WongAtul J Butte

Abstract

Monitoring and ensuring the integrity of data within the clinical trial process is currently not always feasible with the current research system. We propose a blockchain-based system to make data collected in the clinical trial process immutable, traceable, and potentially more trustworthy. We use raw data from a real completed clinical trial, simulate the trial onto a proof of concept web portal service, and test its resilience to data tampering. We also assess its prospects to provide a traceable and useful audit trail of trial data for regulators, and a flexible service for all members within the clinical trials network. We also improve the way adverse events are currently reported. In conclusion, we advocate that this service could offer an improvement in clinical trial data management, and could bolster trust in the clinical research process and the ease at which regulators can oversee trials.

References

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Citations

Oct 5, 2019·BMJ : British Medical Journal·Leeza Osipenko
Dec 25, 2019·NPJ Digital Medicine·Steven R SteinhublRobert M Califf
Mar 21, 2020·Journal of Medical Internet Research·Benjamin Scott GlicksbergEric Collisson
May 16, 2020·Science·Mark B van der WaalLinda H M van de Burgwal
Aug 17, 2020·Journal of Medical Internet Research·MinDong SungYu Rang Park
May 6, 2020·Journal of Medical Ethics·Sebastian Porsdam MannMehdi Benchoufi
Oct 8, 2020·Journal of Medical Ethics·Erik BoettoMaria Pia Fantini
Dec 31, 2020·Sensors·Katarzyna Koptyra, Marek R Ogiela
Nov 20, 2020·Contemporary Clinical Trials·Carmen RosaAimee N C Campbell
Dec 12, 2020·NPJ Digital Medicine·Steven R SteinhublRobert M Califf
Jun 23, 2021·Insights Into Imaging·UNKNOWN European Society of Radiology (ESR)
Apr 21, 2020·Chemical Science·Magnus W D Hanson-Heine, Alexander P Ashmore
Jul 27, 2021·Frontiers in Public Health·Francesco SanmarchiDavide Golinelli
Aug 20, 2021·Journal of Medical Internet Research·Konstantin KoshechkinNatividad Madrid Martinez
Aug 28, 2021·JMIR Medical Informatics·Aldren GonzalesRoger Boodoo

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Clinical Trials Mentioned

NCT00078195

Software Mentioned

Interactive Voice Response System ( IVRS
Django
hashlib
Python
simplecrypt
Bitcoin
GitHub
R
ImmPort

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