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In Silico Clinical Trials for Cardiovascular Disease
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Blockchain Smart Contracts for Automating Clinical Trials: Systematic Review and Proposed System Architecture.

Zara Sheikh1,2, Gargi Samarth1, Usman Jaffer1,3

  • 1Imperial Vascular Unit, St Mary's Hospital, Imperial College Healthcare NHS Trust, Praed Street, London, W2 1NY, United Kingdom, 44 7933513065.

JMIR Medical Informatics
|May 28, 2026
PubMed
Summary
This summary is machine-generated.

Smart contracts (SCs) can improve clinical trial transparency and automation, but current applications are mostly simulations. Further research is needed to address scalability, regulatory issues, and real-world implementation challenges for blockchain in healthcare.

Keywords:
blockchainclinical trialsdata transparencydrug trialsethereumsmart contracts

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Area of Science:

  • Blockchain technology
  • Distributed ledger technology
  • Healthcare informatics

Background:

  • Blockchain offers immutable, secure record-keeping, similar to financial systems.
  • Clinical trials require tamper-resistant data recording for integrity.
  • Smart contracts (SCs) enable automated, sequential execution of predefined tasks on a blockchain.

Purpose of the Study:

  • To review existing literature on smart contract applications in clinical trials.
  • To propose a system architecture for automating clinical trial processes using smart contracts.

Main Methods:

  • Systematic literature search following PRISMA guidelines.
  • Identification of studies and repositories on SCs in clinical trials.
  • Data extraction on trial lifecycle stage, SC architecture, and technical specifications.
  • Synthesis of data to propose a novel SC-based architecture for clinical trial automation.

Main Results:

  • 10 studies met inclusion criteria; most used private Ethereum networks.
  • Key SC applications include automated patient matching, consent management, protocol enforcement, and audit logs.
  • SCs demonstrated rapid patient matching (6000 patients in 2.13s) but faced limitations in scalability, interoperability, and regulatory compliance.

Conclusions:

  • Smart contracts enhance transparency, traceability, and automation in clinical trials.
  • Current research is dominated by simulation-based prototypes with limited real-world testing.
  • Future research should focus on hybrid architectures, interoperability, cost-effectiveness, governance, and regulatory/ethical implications.