ISSN : 2663-2187

Blockchain-Centric Approach for Clinical Trial Environment

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Sindhu Gopinathan Pillai, Dr. Neha Ahire
ยป doi: 10.33472/AFJBS.6.6.2024.6946-6955

Abstract

Introduction: Clinical trials play a crucial role in generating research data that aids in obtaining approval for innovative drugs, instruments, and medical procedures for human use. Clinical data management (CDM) is an intricate and multidisciplinary process that plays a vital role in collecting high-quality and reliable data generated through clinical trials. However, the current workflow of clinical trials is characterized by independent, disconnected activities, leading to up to 10% of clinical research not being replicable due to high error rates caused by human error, fraud, or misbehavior. To address these challenges, blockchain technology has been advocated as a solution to introduce immutability, traceability, and potentially heightened reliability into clinical trial data. Aim: To understand the role of blockchain technology in a clinical trial environment Objectives: 1. To better understand the challenges present in the current clinical trial landscape and explore the potential of blockchain technology as a solution. 2. To evaluate the importance of focusing on the Indian clinical research context when considering implementing blockchain technology in clinical trial data management. 3. To assess the legal aspects of the blockchain's use in managing clinical trial data Methods: This study conducted a systematic literature review to investigate the use of blockchain technology in clinical trial data management. The search was conducted in three databases, including PubMed, Scopus, and the Web of Science, using relevant keywords. Studies were screened for relevance, and the selected studies were subjected to data extraction and synthesis using a thematic approach. The study aimed to explore the current state of research on blockchain technology in clinical trials. The search was limited to studies published in English and conducted up to April 2023 Findings: The clinical trial environment involves planning, executing, and monitoring new treatments, drugs, or medical devices on human subjects, while also considering ethical and legal issues such as informed consent, privacy, confidentiality, and compliance with regulatory requirements. Clinical trials typically cost millions of dollars and require proper data management and security to protect public health and ensure confidence in marketed products. Blockchain technology can offer solutions for managing clinical trial data, but legal aspects such as GDPR, HIPAA, and DISHA must be considered to protect individuals' health data. Blockchain databases must adhere to HIPAA regulations on data processing and ensure the protection of PHI. Patients' enrollment in clinical trials, trial management, and ongoing monitoring can be handled through secure smart contracts. Conclusion: Nationwide data protection regulations are crucial in clinical trials, as electronic health records serve as a national healthcare database. The collection, processing, and sharing of personal and medical information in clinical trials makes it essential to have a comprehensive data protection framework. This would encourage patient participation in clinical trials and innovative therapies, promoting trust and confidence in the healthcare sector. The implementation of blockchain technology, like Guardtime's Keyless Signature Infrastructure (KSI), can improve data protection and promote transparency in national healthcare databases, benefiting stakeholders in clinical trials. The successful implementation of blockchain technology in Estonia shows the importance of trust between private companies and government officials, who can collaborate to implement it in phases using consortium blockchains.

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