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Updated: Aug 10, 2025

Digital Home-Monitoring of Patients after Kidney Transplantation: The MACCS Platform
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Leveraging Blockchain Technology for Informed Consent Process and Patient Engagement in a Clinical Trial Pilot.

Baldwin C Mak1, Bryan T Addeman2, Jia Chen3

  • 1Department of Clinical Operations, Boehringer Ingelheim Canada Ltd./Ltée, Burlington, ON, Canada.

Blockchain in Healthcare Today
|February 13, 2023
PubMed
Summary

Blockchain technology significantly reduces clinical trial management time and cost. This innovation enhances patient trust, transparency, and empowerment, offering a more efficient and patient-centric approach to clinical research.

Keywords:
Hyperledger Fabricblockchainclinical trialshealthcare and medical researchinformed consent

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Area of Science:

  • Clinical Trial Management
  • Health Informatics
  • Blockchain Technology

Background:

  • Current clinical trial management is inefficient, costly, and lacks patient empowerment.
  • Quality assurance procedures do not fully address issues of trust and transparency.
  • Existing processes are time-consuming and prone to errors, limiting patient engagement.

Purpose of the Study:

  • To evaluate blockchain technology's potential to improve trust, transparency, and patient empowerment in clinical trial data management.
  • To assess the impact of blockchain on reducing clinical trial costs.
  • To determine if blockchain can enhance patient-centricity in clinical research.

Main Methods:

  • A proof-of-concept pilot using a Hyperledger Fabric-based blockchain system was deployed in an active clinical trial.
  • A parallel study design compared blockchain technology against standard clinical trial management methodologies.
  • Data collected included mean monitoring visit time, cost, non-compliances, and user experience.

Main Results:

  • Blockchain technology significantly reduced mean monitoring visit time (475 to 7 min) and cost (€722 to €10) per participant/visit (P = 0.001).
  • Patient trust, transparency, and empowerment were enhanced in 91%, 82%, and 63% of patients, respectively.
  • No significant difference in non-compliances, a marker of trial quality, was observed between the groups.

Conclusions:

  • Blockchain technology demonstrates potential for improving patient-centricity and reducing costs in clinical trials.
  • The findings suggest blockchain can enhance trust and transparency in clinical trial data management.
  • Further investigation is warranted to explore blockchain's impact on overall clinical trial quality.