Blockchain Smart Contracts for Automating Clinical Trials: Systematic Review and Proposed System Architecture - Report - MDSpire

Blockchain Smart Contracts for Automating Clinical Trials: Systematic Review and Proposed System Architecture

  • By

  • Zara Sheikh

  • Gargi Samarth

  • Usman Jaffer

  • May 28, 2026

  • 0 min

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Clinical Report: Utilizing Blockchain Smart Contracts to Streamline Clinical Trials

Overview

This review explores the application of blockchain smart contracts (SCs) in enhancing the efficiency, transparency, and security of clinical trials. It identifies key use cases and architectural patterns in SC-based systems, addressing challenges such as patient recruitment and data integrity.

Background

Clinical trials face significant challenges, including patient recruitment difficulties, data integrity issues, and administrative burdens. Traditional centralized systems are prone to breaches and errors, which can undermine trial credibility. The integration of blockchain technology, particularly through smart contracts, presents a potential solution to enhance transparency and streamline processes in clinical research.

Data Highlights

No numerical data or trial data presented in the article.

Key Findings

  • Blockchain technology provides a decentralized, tamper-resistant ledger for clinical trials.
  • Smart contracts can automate processes such as patient matching and consent acquisition.
  • SCs improve data sharing and permissions while ensuring protocol adherence.
  • The review identifies both the potential and limitations of current blockchain applications in clinical research.
  • Key use cases include optimizing patient recruitment and automating trial governance.

Clinical Implications

The findings suggest that blockchain SCs could significantly enhance the management of clinical trials by improving data integrity and operational efficiency. Implementing these technologies may help address long-standing challenges in patient recruitment and retention.

Conclusion

The review highlights the transformative potential of blockchain smart contracts in clinical trials, while also acknowledging existing limitations that need to be addressed for broader implementation.

Related Resources & Content

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  3. BJS (British Journal of Surgery), 2025 -- Framework for Enhancing the Design, Implementation, and Reporting of Clinical Trials in Endovascular Treatment for Peripheral Arterial Disease: The Endo-STAR Initiative
  4. the medicine maker, 2026 -- Rethinking Progress in Clinical Trials
  5. INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL, 2025 -- ICH E6(R3) Good Clinical Practice guideline
  6. Blockchain based clinical trial management system: A scoping review and conceptual framework | medRxiv, 2024
  7. INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL
  8. Blockchain based clinical trial management system: A scoping review and conceptual framework | medRxiv

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