Blockchain Clinical Trial Data Management with Encryption
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current clinical trial data management systems face challenges in ensuring data integrity and security due to centralized data recording, vulnerability to network errors, data leakage, and forgery, particularly in sharing information among multiple entities.
Innovation Solution
A blockchain network scheme is implemented to enable real-time sharing of clinical trial data among hospitals, CRO groups, and admin entities while encrypting and anonymizing data using RESTful API routers, Base64 encryption, and SHA-256 hash encryption, ensuring only authorized groups can access specific information.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If clinical trial data is recorded in a centralized manner, then data management is simplified and easy to operate, but the system becomes vulnerable to network errors, data leakage, and forgery, reducing reliability
Solution Approach 1:
The patent divides the centralized data management system into a distributed blockchain network where multiple entities (hospitals, CROs, regulators) each maintain independent nodes. Clinical trial data is segmented across these distributed nodes rather than stored centrally, eliminating single points of failure and improving both reliability and security while maintaining operational simplicity through standardized protocols.
Solution Approach 2:
The patent introduces blockchain technology as an intermediary layer between data generators (hospitals) and data users (CROs, regulators). This intermediary provides cryptographic verification, consensus mechanisms, and smart contracts that ensure data integrity and security without requiring complex point-to-point trust relationships, thus maintaining ease of operation while significantly improving reliability.
2Productivity
If clinical trial data is shared in real-time among multiple entities, then productivity and collaboration are improved, but the risk of unauthorized access and data leakage increases
Solution Approach 1:
The patent implements role-based access control where different entities (hospitals, CROs, regulators, sponsors) have different levels of access permissions to different portions of the clinical trial data. Each user or organization sees only the data relevant to their role, enabling real-time collaboration and productivity while minimizing exposure to unauthorized access and data leakage risks.
Solution Approach 2:
The patent uses cryptographic transformation to change the state of data from readable to encrypted form. Sensitive clinical trial data is encrypted using advanced cryptographic algorithms, and only authorized entities with appropriate decryption keys can access the plaintext. This parameter change from encrypted to decrypted state ensures high-security data sharing where productivity is maintained through efficient encrypted data transmission while unauthorized access is prevented.
3Reliability
If encryption is applied to clinical trial data, then security and anonymity are enhanced, but data processing and analysis become more complex
Solution Approach 1:
The patent applies encryption to clinical trial data at the point of generation or entry, before any processing or analysis occurs. This preliminary cryptographic transformation ensures that data is protected from the moment it is created, enhancing security and anonymity without requiring complex decryption processes during subsequent analysis, as the encryption is already in place and managed through automated key distribution mechanisms.
Solution Approach 2:
The patent creates cryptographic copies (hashes) of clinical trial data that can be shared and verified without exposing the original sensitive information. These cryptographic representations allow data integrity verification and analysis while maintaining security, reducing the complexity of handling encrypted data by working with simpler hash values rather than managing complex encrypted data structures throughout the processing pipeline.
Data Source
AI summary
Provided are a system and method for managing clinical trial data using a blockchain network scheme which allow hospitals, a contract research organization (CRO) group, and a blockchain network admin entity to share clinical trial data resulting from a clinical trial in real time on the basis of a blockchain network but forbid a hospital from accessing data generated from a plurality of other clinical hospitals in one clinical trial, encode and encrypt recorded information such that interpretation is not possible even through direct blockchain network access, and thereby ensure the integrity of clinical trial result data and enhance anonymity and security thereof.