scholarly journals Applications of Blockchain Technology in Clinical Trials: Review and Open Challenges

2020 ◽  
Author(s):  
Ilhaam Omar ◽  
Raja Jayaraman ◽  
Khaled Salah ◽  
Ibrar Yaqoob ◽  
Samer Ellahham
Keyword(s):  
Clinical Trials ◽  
Data Management ◽  
Healthcare Sector ◽  
Data Provenance ◽  
Successful Implementation ◽  
Retention Data ◽  
Regulatory Policies ◽  
Blockchain Technology ◽  
True Value ◽  
Comprehensive Survey

<p>Blockchain technology has disclosed unprecedented opportunities in the healthcare sector by unlocking the true value of interoperability. Specifically, the striking features of blockchain technology, such as data provenance, transparency, decentralized transaction validation, and immutability can help to compensate for stringent data management issues (e.g., patient recruitment, persistent monitoring, data management, and data analytics and accurate reporting) in clinical trials (CTs). Although several research studies show that blockchain solutions help to improve patient retention, data integrity, privacy, and ensure CTs compliance with regulatory policies, a comprehensive survey on this topic is lacking. In this survey, we provide insights into the adoption of blockchain technology in CTs. We categorize and classify the literature by devising a meticulous taxonomy of the decentralized tasks of CT and practices based on indispensable parameters. Furthermore, we provide insights on works in progress towards deploying blockchain solutions in CTs. Finally, we identify and discuss several challenges that hinder the successful implementation of blockchain technologies in CTs.</p>

scholarly journals Applications of Blockchain Technology in Clinical Trials: Review and Open Challenges

2020 ◽  
Author(s):  
Ilhaam Omar ◽  
Raja Jayaraman ◽  
Khaled Salah ◽  
Ibrar Yaqoob ◽  
Samer Ellahham
Keyword(s):  
Clinical Trials ◽  
Data Management ◽  
Healthcare Sector ◽  
Data Provenance ◽  
Successful Implementation ◽  
Retention Data ◽  
Regulatory Policies ◽  
Blockchain Technology ◽  
True Value ◽  
Comprehensive Survey

<p>Blockchain technology has disclosed unprecedented opportunities in the healthcare sector by unlocking the true value of interoperability. Specifically, the striking features of blockchain technology, such as data provenance, transparency, decentralized transaction validation, and immutability can help to compensate for stringent data management issues (e.g., patient recruitment, persistent monitoring, data management, and data analytics and accurate reporting) in clinical trials (CTs). Although several research studies show that blockchain solutions help to improve patient retention, data integrity, privacy, and ensure CTs compliance with regulatory policies, a comprehensive survey on this topic is lacking. In this survey, we provide insights into the adoption of blockchain technology in CTs. We categorize and classify the literature by devising a meticulous taxonomy of the decentralized tasks of CT and practices based on indispensable parameters. Furthermore, we provide insights on works in progress towards deploying blockchain solutions in CTs. Finally, we identify and discuss several challenges that hinder the successful implementation of blockchain technologies in CTs.</p>

scholarly journals Blockchain for Electric Vehicles Energy Trading: Requirements, Opportunities, and Challenges

2021 ◽  
Author(s):  
Nasser Al-Saif ◽  
Raja Wasim Ahmad ◽  
Khaled Salah ◽  
Ibrar Yaqoob ◽  
Raja Jayaraman ◽  
...  
Keyword(s):  
Fault Tolerance ◽  
Case Studies ◽  
Electric Vehicles ◽  
Single Point ◽  
Data Provenance ◽  
Successful Implementation ◽  
Research Projects ◽  
Energy Trading ◽  
Blockchain Technology ◽  
Trusted Data

Today's technologies, techniques, and systems leveraged for managing energy trading operations in electric vehicles fall short in providing operational transparency, immutability, fault tolerance, traceability, and trusted data provenance features. They are centralized and vulnerable to the single point of failure problem, and less trustworthy as they are prone to the data modifications and deletion by adversaries. In this paper, we present the potential advantages of blockchain technology to manage energy trading operations between electric vehicles as it can offer data traceability, immutability, transparency, audit, security, and confidentiality in a fully decentralized manner. We identify and discuss the essential requirements for the successful implementation of blockchain technology to secure energy trading operations among electric vehicles. We present a detailed discussion on the potential opportunities offered by blockchain technology to secure the energy trading operations of electric vehicles. We discuss several blockchain-based research projects and case studies to highlight the practicability of blockchain technology in electric vehicles energy trading. Finally, we identify and discuss open challenges in fulfilling the requirements of electric vehicles energy trading applications.

scholarly journals Critical Dimensions of Blockchain Technology Implementation in the Healthcare Industry: An Integrated Systems Management Approach

2021 ◽  
Vol 13 (9) ◽  
pp. 5269
Author(s):  
Satyabrata Aich ◽  
Sushanta Tripathy ◽  
Moon-Il Joo ◽  
Hee-Cheol Kim
Keyword(s):  
Technology Implementation ◽  
Healthcare Sector ◽  
Management Approach ◽  
Successful Implementation ◽  
Healthcare Industry ◽  
Critical Factors ◽  
Privacy And Security ◽  
Interpretive Structural Modeling ◽  
Critical Dimensions ◽  
Blockchain Technology

In the digital era, almost every system is connected to a digital platform to enhance efficiency. Although life is thus improved, security issues remain important, especially in the healthcare sector. The privacy and security of healthcare records is paramount; data leakage is socially unacceptable. Therefore, technology that protects data but does not compromise efficiency is essential. Blockchain technology has gained increasing attention as it ensures transparency, trust, privacy, and security. However, the critical factors affecting efficiency require further study. Here, we define the critical factors that affect blockchain implementation in the healthcare industry. We extracted such factors from the literature and from experts, then used interpretive structural modeling to define the interrelationships among these factors and classify them according to driving and dependence forces. This identified key drivers of the desired objectives. Regulatory clarity and governance (F2), immature technology (F3), high investment cost (F6), blockchain developers (F9), and trust among stakeholders (F12) are key factors to consider when seeking to implement blockchain technology in healthcare. Our analysis will allow managers to understand the requirements for successful implementation.

scholarly journals Data Validation and Verification Using Blockchain in a Clinical Trial for Breast Cancer: Regulatory Sandbox (Preprint)

2020 ◽  
Author(s):  
Tomonobu Hirano ◽  
Tomomitsu Motohashi ◽  
Kosuke Okumura ◽  
Kentaro Takajo ◽  
Taiyo Kuroki ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Data Management ◽  
Clinical Data ◽  
Clinical Trial Data ◽  
Research Process ◽  
Current Data ◽  
Data Management System ◽  
Blockchain Technology

BACKGROUND The integrity of data in a clinical trial is essential, but the current data management process is too complex and highly labor-intensive. As a result, clinical trials are prone to consuming a lot of budget and time, and there is a risk for human-induced error and data falsification. Blockchain technology has the potential to address some of these challenges. OBJECTIVE The aim of the study was to validate a system that enables the security of medical data in a clinical trial using blockchain technology. METHODS We have developed a blockchain-based data management system for clinical trials and tested the system through a clinical trial for breast cancer. The project was conducted to demonstrate clinical data management using blockchain technology under the regulatory sandbox enabled by the Japanese Cabinet Office. RESULTS We verified and validated the data in the clinical trial using the validation protocol and tested its resilience to data tampering. The robustness of the system was also proven by survival with zero downtime for clinical data registration during a Amazon Web Services disruption event in the Tokyo region on August 23, 2019. CONCLUSIONS We show that our system can improve clinical trial data management, enhance trust in the clinical research process, and ease regulator burden. The system will contribute to the sustainability of health care services through the optimization of cost for clinical trials.

scholarly journals Data Validation and Verification Using Blockchain in a Clinical Trial for Breast Cancer: Regulatory Sandbox

10.2196/18938 ◽  
2020 ◽  
Vol 22 (6) ◽  
pp. e18938
Author(s):  
Tomonobu Hirano ◽  
Tomomitsu Motohashi ◽  
Kosuke Okumura ◽  
Kentaro Takajo ◽  
Taiyo Kuroki ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Data Management ◽  
Clinical Data ◽  
Clinical Trial Data ◽  
Research Process ◽  
Current Data ◽  
Data Management System ◽  
Blockchain Technology

Background The integrity of data in a clinical trial is essential, but the current data management process is too complex and highly labor-intensive. As a result, clinical trials are prone to consuming a lot of budget and time, and there is a risk for human-induced error and data falsification. Blockchain technology has the potential to address some of these challenges. Objective The aim of the study was to validate a system that enables the security of medical data in a clinical trial using blockchain technology. Methods We have developed a blockchain-based data management system for clinical trials and tested the system through a clinical trial for breast cancer. The project was conducted to demonstrate clinical data management using blockchain technology under the regulatory sandbox enabled by the Japanese Cabinet Office. Results We verified and validated the data in the clinical trial using the validation protocol and tested its resilience to data tampering. The robustness of the system was also proven by survival with zero downtime for clinical data registration during a Amazon Web Services disruption event in the Tokyo region on August 23, 2019. Conclusions We show that our system can improve clinical trial data management, enhance trust in the clinical research process, and ease regulator burden. The system will contribute to the sustainability of health care services through the optimization of cost for clinical trials.

scholarly journals Realizing the Role of Permissioned Blockchains in a Systems Engineering Lifecycle

Systems ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 41
Author(s):  
Demetrios Joannou ◽  
Roy Kalawsky ◽  
Miguel Martínez-García ◽  
Chris Fowler ◽  
Kevin Fowler
Keyword(s):  
Data Management ◽  
Systems Engineering ◽  
New Technology ◽  
Data Provenance ◽  
Digital Information ◽  
Digital Tool ◽  
Blockchain Technology ◽  
Secure Access ◽  
Digital Twins ◽  
Permissioned Blockchains

A key requirement for an integrated digital tool chain is secure access and control of data assets. Not all stakeholders will have the same access to or control over the flow of information, some will be able to input or change data whilst others will only be able to read the data. Simply providing secure access protocols is not sufficient because copied data can quickly become disassociated and modified from its original instantiation, leading to its reuse elsewhere or later in the lifecycle but in an inappropriate way. Therefore, data management mechanisms are required that capture information about the data along with any decisions or modifications it has undergone during the course of its life, thus providing complete traceability for later validation purposes. This undertaking is essential across the systems engineering lifecycle. This pursuit involves controlling who can access and modify data within the lifecycle. This paper describes a solution to this by the introduction of blockchain technology, a relatively new technology that allows digital information to be distributed but not copied, making it an immutable set of time-stamped data managed by a network of connected systems and services. Though blockchain technology is not commonly referred to when discussing Industry 4.0, the technology’s capabilities should add value when applied in a context of data management and security within the lifecycle of a product or services and in conjunction with digital twins, big data, and IoT. This paper describes how permissioned blockchains can be implemented within a systems engineering lifecycle, providing example architecture patterns showing how data provenance can be maintained throughout.

Blockchain Reinventing the Healthcare Industry

2021 ◽  
pp. 309-328
Author(s):  
Vijayaraghavan Varadharajan ◽  
Divik Bansal ◽  
Sanal J. Nair ◽  
Rian Leevinson J
Keyword(s):  
Clinical Trials ◽  
Case Studies ◽  
Scientific Research ◽  
Healthcare Sector ◽  
Medical Applications ◽  
Healthcare Industry ◽  
Counterfeit Drugs ◽  
Data Interoperability ◽  
Blockchain Technology ◽  
Conducting Research

The fragmented and disorganized nature of data in healthcare poses a variety of challenges to scientific research and medical applications. This mainly stems from the lack of traceability of transactions, complex disconnected networks, and lack of data interoperability. This complexity leads to difficulties in conducting research and clinical trials, and to the problem of counterfeit drugs in the market. This triggers lack of availability and accessibility of data for researchers and medical experts. Blockchain technology offers comprehensive solutions to these problems, and hence it has been of enormous interest in the healthcare sector. Blockchain technology with its innate transparency, traceability, data security, and distributed nature can help to overcome the data related problems in healthcare. This chapter provides an overview of the use of blockchain in the healthcare industry and explores various use-cases and applications. This chapter also discusses case-studies and various challenges faced while adapting blockchain in the healthcare industry.

Applying Blockchain Technologies in Healthcare

2020 ◽  
pp. 69-92
Author(s):  
Zehra Ozge Candereli ◽  
Serhat Burmaoglu ◽  
Levent B. Kidak ◽  
Dilek Ozdemir Gungor
Keyword(s):  
Clinical Trials ◽  
Data Management ◽  
Health Data ◽  
Digital Identity ◽  
Payment Systems ◽  
Privacy And Security ◽  
Security Issues ◽  
Blockchain Technology ◽  
Application Fields ◽  
The Web

Recently, one of the inventive developments penetrating many industries is blockchain technology. In the era of globalization and digitalization, blockchain has garnered interest in various application fields from health data management to clinical trials. In this study, we aimed to explore blockchain applications in healthcare with an explorative perspective with a scientometrics analysis. With this analysis, the trends and evolutionary relations between health and blockchain technology were examined via the queries in the Web of Science database. In the analysis, the author keyword co-occurrences were used for demonstrating concept relationships. To understand the new emerging study field, VosViewer was used for network visualizations and CiteSpace free java-based software was used for scientometrics analysis. As a result, it can be implied that the main focus areas of the studies on blockchain are solving payment systems, digital identity, and privacy and security issues in healthcare field.

scholarly journals Secure and Scalable mHealth Data Management Using Blockchain Combined With Client Hashchain: System Design and Validation (Preprint)

2019 ◽  
Author(s):  
Tomomitsu Motohashi ◽  
Tomonobu Hirano ◽  
Kosuke Okumura ◽  
Makiko Kashiyama ◽  
Daisuke Ichikawa ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Data Management ◽  
Mobile Devices ◽  
Medical Practice ◽  
Chain Structure ◽  
Medical Data ◽  
Third Party ◽  
Innovative Technology ◽  
Blockchain Technology ◽  
Network Fault

BACKGROUND Blockchain is emerging as an innovative technology for secure data management in many areas, including medical practice. A distributed blockchain network is tolerant against network fault, and the registered data are resistant to tampering and revision. The technology has a high affinity with digital medicine like mobile health (mHealth) and provides reliability to the medical data without labor-intensive third-party contributions. On the other hand, the reliability of the medical data is not insured before registration to the blockchain network. Furthermore, there are issues with regard to how the clients' mobile devices should be dealt with and authenticated in the blockchain network in order to avoid impersonation. OBJECTIVE The aim of the study was to design and validate an mHealth system that enables the compatibility of the security and scalability of the medical data using blockchain technology. METHODS We designed an mHealth system that sends medical data to the blockchain network via relay servers. The architecture provides scalability and convenience of operation of the system. In order to ensure the reliability of the data from clients' mobile devices, hash values with chain structure (client hashchain) were calculated in the clients' devices and the results were registered on the blockchain network. RESULTS The system was applied and deployed in mHealth for insomnia treatment. Clinical trials for mHealth were conducted with insomnia patients. Medical data of the recruited patients were successfully registered with the blockchain network via relay servers along with the hashchain calculated on the clients' mobile devices. The correctness of the data was validated by identifying illegal data, which were made by simulating fraudulent access. CONCLUSIONS Our proposed mHealth system, blockchain combined with client hashchain, ensures compatibility of security and scalability in the data management of mHealth medical practice. CLINICALTRIAL UMIN Clinical Trials Registry UMIN000032951; https://upload.umin.ac.jp/cgi-open- bin/ctr_e/ctr_view.cgi?recptno=R000037564 (Archived by WebCite at http://www.webcitation.org/78HP5iFIw)

Clinical Trial Data Management Software: A Review of the Technical Features

2019 ◽  
Vol 14 (3) ◽  
pp. 160-172 ◽  
Author(s):  
Aynaz Nourani ◽  
Haleh Ayatollahi ◽  
Masoud Solaymani Dodaran
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Data Management ◽  
Clinical Data ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Data Management System ◽  
Management Systems ◽  
Data Management Systems ◽  
Technical Features

Background:Data management is an important, complex and multidimensional process in clinical trials. The execution of this process is very difficult and expensive without the use of information technology. A clinical data management system is software that is vastly used for managing the data generated in clinical trials. The objective of this study was to review the technical features of clinical trial data management systems.Methods:Related articles were identified by searching databases, such as Web of Science, Scopus, Science Direct, ProQuest, Ovid and PubMed. All of the research papers related to clinical data management systems which were published between 2007 and 2017 (n=19) were included in the study.Results:Most of the clinical data management systems were web-based systems developed based on the needs of a specific clinical trial in the shortest possible time. The SQL Server and MySQL databases were used in the development of the systems. These systems did not fully support the process of clinical data management. In addition, most of the systems lacked flexibility and extensibility for system development.Conclusion:It seems that most of the systems used in the research centers were weak in terms of supporting the process of data management and managing clinical trial's workflow. Therefore, more attention should be paid to design a more complete, usable, and high quality data management system for clinical trials. More studies are suggested to identify the features of the successful systems used in clinical trials.

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