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Blockchain as a Prime Guardian: Securing Clinical Trial Data Integrity
Nikhil Sethi1, Charul Rathore1, Dilpreet Singh1
1University Institute of Pharma Sciences, Chandigarh University, Gharuan, Mohali, 140413, India.
Reviews on Recent Clinical Trials
|January 24, 2025
Summary
Blockchain technology enhances clinical trial data security and integrity. It ensures transparency, prevents data tampering, and improves regulatory oversight for reliable trial outcomes.
Area of Science:
- Health Informatics
- Information Security
- Clinical Research
Background:
- Clinical trials face increasing complexity and international scope, necessitating robust data management.
- Ensuring data quality, integrity, transparency, and legal compliance is paramount in modern clinical investigations.
Purpose of the Study:
- To explore the application of blockchain technology for secure data management in clinical trials.
- To address challenges in data revisions, selective data release, and compliance auditing.
Main Methods:
- Review of blockchain's features: distributed, immutable, time-stamped ledger.
- Analysis of blockchain's potential for multi-center study surveillance and patient confidentiality.
- Examination of blockchain's role in internal accountability and bias avoidance in outcome reporting.
Main Results:
- Blockchain offers a secure and transparent platform for clinical trial data management.
- Immutable records enhance internal accountability and prevent data alteration.
- Facilitates unbiased reporting of all trial outcomes, both positive and negative.
Conclusions:
- Blockchain technology can significantly improve the validity and reliability of clinical trial data.
- Digital ledger technology provides a robust solution for reputation management in clinical research.
- Blockchain adoption is recommended for enhanced data security and regulatory compliance in clinical trials.
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