BACKGROUND: A clinical trial management system (CTMS) is a suite of specialized productivity tools that manage clinical trial processes from study planning to closeout. Using CTMSs has shown remarkable benefits in delivering efficient, auditable, and visualizable clinical trials. However, the current CTMS market is fragmented, and most CTMSs fail to meet expectations because of their inability to support key functions, such as inconsistencies in data captured across multiple sites. Blockchain technology, an emerging distributed ledger technology, is considered to potentially provide a holistic solution to current CTMS challenges by using its unique features, such as transparency, traceability, immutability, and security. OBJECTIVE: This study aimed to re-engineer the traditional CTMS by leveraging the unique properties of blockchain technology to create a secure, auditable, efficient, and generalizable CTMS. METHODS: A comprehensive, blockchain-based CTMS that spans all stages of clinical trials, including a sharable trial master file system; a fast recruitment and simplified enrollment system; a timely, secure, and consistent electronic data capture system; a reproducible data analytics system; and an efficient, traceable payment and reimbursement system, was designed and implemented using the Quorum blockchain. Compared with traditional blockchain technologies, such as Ethereum, Quorum blockchain offers higher transaction throughput and lowers transaction latency. Case studies on each application of the CTMS were conducted to assess the feasibility, scalability, stability, and efficiency of the proposed blockchain-based CTMS. RESULTS: A total of 21.6 million electronic data capture transactions were generated and successfully processed through blockchain, with an average of 335.4 transactions per second. Of the 6000 patients, 1145 were matched in 1.39 seconds using 10 recruitment criteria with an automated matching mechanism implemented by the smart contract. Key features, such as immutability, traceability, and stability, were also tested and empirically proven through case studies. CONCLUSIONS: This study proposed a comprehensive blockchain-based CTMS that covers all stages of the clinical trial process. Compared with our previous research, the proposed system showed an overall better performance. Our system design, implementation, and case studies demonstrated the potential of blockchain technology as a potential solution to CTMS challenges and its ability to perform more health care tasks.
Patrick Silva, Deborah Vollmer Dahlke, Matthew Lee Smith, Wendy Charles ยท 7 authors
Current best practices in tumor registries provide a glimpse into a limited time frame over the natural history of disease, usually a narrow window around diagnosis and biopsy. This creates challenges meeting public health and healthcare reimbursement policies that increasingly require robust documentation of long-term clinical trajectories, quality of life, and health economics outcomes. These challenges are amplified for underrepresented minority (URM) and other disadvantaged populations, who tend to view the institution of clinical research with skepticism. Participation gaps leave such populations underrepresented in clinical research and, importantly, in policy decisions about treatment choices and reimbursement, thus further augmenting health, social, and economic disparities. Cloud computing, mobile computing, digital ledgers, tokenization, and artificial intelligence technologies are powerful tools that promise to enhance longitudinal patient engagement across the natural history of disease. These tools also promise to enhance engagement by giving participants agency over their data and addressing a major impediment to research participation. This will only occur if these tools are available for use with all patients. Distributed ledger technologies (specifically blockchain) converge these tools and offer a significant element of trust that can be used to engage URM populations more substantively in clinical research. This is a crucial step toward linking composite cohorts for training and optimization of the artificial intelligence tools for enhancing public health in the future. The parameters of an idealized clinical genomic registry are presented.
Fidelia Cascini, Flavia Beccia, Francesco Andrea Causio, Andrea Gentili ยท 7 authors
The recent progress of genomics research is providing unprecedented insight into human genetic variance, susceptibility to disease and risk stratification. Current trends predict that a massive amount of genomic data will be produced in the upcoming years which, when coupled with the fast-paced development of the field, will create new social, ethical, and legal challenges. In the complex legislative environment of the European Union, genomic data sharing policies will have to weigh the benefits of scientific discovery against the ethical risks posed by the act of sharing sensitive data. In this complex, interconnected environment, blockchain provides a unique and novel solution to accountability, traceability, and transparency issues regarding genomic data sharing. Implementing a distributed ledger technology-based database could empower both patients and citizens to responsibly use genomic data pertaining to them because it allows for a higher degree of control over the recipients of their data and their uses. The blockchain technology will engage both data owners and policymakers to address the multiple issues of genomic data sharing and allow us to redefine the way we look at genomics.
Baldwin C. Mak, Bryan T. Addeman, Jia Chen, Kim Papp ยท 9 authors
Objective: Despite the implementation of quality assurance procedures, current clinical trial management processes are time-consuming, costly, and often susceptible to error. This can result in limited trust, transparency, and process inefficiencies, without true patient empowerment. The objective of this study was to determine whether blockchain technology could enforce trust, transparency, and patient empowerment in the clinical trial data management process, while reducing trial cost. Design: In this proof of concept pilot, we deployed a Hyperledger Fabric-based blockchain system in an active clinical trial setting to assess the impact of blockchain technology on mean monitoring visit time and cost, non-compliances, and user experience. Using a parallel study design, we compared differences between blockchain technology and standard methodology. Results: A total of 12 trial participants, seven study coordinators and three clinical research associates across five sites participated in the pilot. Blockchain technology significantly reduces total mean monitoring visit time and cost versus standard trial management (475 to 7 min; P = 0.001; โฌ722 to โฌ10; P = 0.001 per participant/visit, respectively), while enhancing patient trust, transparency, and empowerment in 91, 82 and 63% of the patients, respectively. No difference in non-compliances as a marker of trial quality was detected. Conclusion: Blockchain technology holds promise to improve patient-centricity and to reduce trial cost compared to conventional clinical trial management. The ability of this technology to improve trial quality warrants further investigation.
Marielle S. Gross, Amelia Hood, Robert C Miller Jr
Henrietta Lacks' deidentified tissue became HeLa cells (the paradigmatic learning health platform). In this article, we discuss separating research on Ms Lacks' tissue from obligations to promote respect, beneficence, and justice for her as a patient. This case illuminates ethical challenges for the secondary use of biospecimens, which persist in contemporary learning health systems. Deidentification and broad consent seek to maximize the benefits of learning from care by minimizing burdens on patients, but these strategies are insufficient for privacy, transparency, and engagement. The resulting supply chain for human cellular and tissue-based products may therefore recapitulate the harms experienced by the Lacks family. We introduce the potential for blockchain technology to build unprecedented transparency, engagement, and accountability into learning health system architecture without requiring deidentification. The ability of nonfungible tokens to maintain the provenance of inherently unique digital assets may optimize utility, value, and respect for patients who contribute tissue and other clinical data for research. We consider the potential benefits and survey major technical, ethical, socioeconomic, and legal challenges for the successful implementation of the proposed solutions. The potential for nonfungible tokens to promote efficiency, effectiveness, and justice in learning health systems demands further exploration.
Open access
Ethics in Clinical Research
Biomedical Ethics and Regulation
Neuroethics, Human Enhancement, Biomedical Innovations
Abstract Introduction/Objective My role model when I was a medical technologist intern was a chief pathologist who taught me to speak up when something is unsafe and to serve willingly, do what is right, be fair and excellent in work. His character impacted my whole life and career. Every moment matters; life is precious and something to protect. The patient and their care teams depend upon accurate, safe and high-quality clinical laboratory tests result to achieve positive patient outcomes. Methods/Case Report Clinical Practice Results (if a Case Study enter NA) We can do better. Everybody can be surveyors with greater understanding of pathophysiologic processes in disease, extensive experience working in laboratories and in-depth knowledge about complaince, quality, mistake-proofing care, patient-focused and laboratory management. Diagnostic testing would be the method to screen for disease, confirm disease, and monitor disease in hopes of secondary prevention - to identify latent disease to โcatch it early.โ The screening tests could be anything from newborn screening for inborn metabolism errors, adult screening tests (like mammograms, pap smears, and colonoscopies), to high-risk population screenings to detect HIV, RPR, and gonorrhea. The disease must have a high prevalence to justify the expense of therapy and should be detectable before symptoms arise. The test must not have many false positives but extremely high sensitivity. The results of these tests could lead to the three different methods of prevention. Primary prevention would reduce the risk of developing cardiovascular disease or stroke. Secondary prevention would detect the disease early to prevent progression of the disease. Tertiary prevention would reduce disabilty and promotion of rehabilitation from the disease like strokes or rehab programs. Conclusion In conclusion, this information provides clinicians with a laboratory test menu guidelines to improve clinical practice. We can all learn well to focus on what really matters. Together, we can make healthcare better, more patient-centered, less costly, and safer.
Approaches developed based on the blockchain concept can provides a framework for the realization of open science. The traditional centralized way of data collection and curation is a labor-intensive work that is often not updated. The fundamental contribution of developing blockchain format of microbial databases includes: 1. Scavenging the sparse data from different strain database; 2. Tracing a specific thread of access for the purpose of evaluation or even the forensic; 3. Mapping the microbial species diversity; 4. Enrichment of the taxonomic database with the biotechnological applications of the strains and 5. Data sharing with the transparent way of precedent recognition. The plausible applications of constructing microbial databases using blockchain technology is proposed in this paper. Nevertheless, the current challenges and constraints in the development of microbial databases using the blockchain module are discussed in this paper.
<p class="abstract">Drug development is a complex and resource intensive endeavor. The average cost of developing a new drug, has been estimated to be $2 to $3 billion. However, the success rate of clinical trials is very low around and is estimated to be between 3-5%. The common reasons for failure of clinical trials include failure to demonstrate efficacy or safety, budgeting and financing, failure of subjects meeting protocol eligibility criteria, poor investigator site selection, patient withdrawals and dropouts. Considering the growing demands to get better and affordable treatment options, there needs to be fundamental shift required in drug development and specifically the clinical trials oversight processes to mitigate risks and reduce failures. The International Council for Harmonisation in the E6 R2 addendumhas now provided guidelines for adaptation of risk based approach to trial conduct and monitoring to implement mitigation strategies for potential risks which might derail the conduct of the trail. The industry is steadily gearing up to put together the required processes, systems and teams to align to the new ways of working. However with the changing landscape of drug development which includes novel therapies like gene therapy, remote/decentralized trials, growing use of wearable technologies, esource, electronic health record/electronic medical records interoperability, implementation of artificial intelligence and machine learning algorithms, the future of risk based approach towards managing clinical trials is going to be very different from what we see now. This paper explores the impact of these new developments on the future of risk based monitoring in clinical trials.</p>
Open access
Biomedical Ethics and Regulation
Ethics in Clinical Research
Health Systems, Economic Evaluations, Quality of Life
Ilhaam A. Omar, Raja Jayaraman, Khaled Salah, Ibrar Yaqoob ยท 5 authors
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.
Open access
2 source records
Blockchain Technology Applications and Security
IoT and Edge/Fog Computing
Artificial Intelligence in Healthcare and Education
Sebastian Porsdam Mann, Julian Savulescu, Philippe Ravaud, Mehdi Benchoufi
Recent advances in medical and information technologies, the availability of new types of medical data, the requirement of increasing numbers of study participants, as well as difficulties in recruitment and retention, all present serious problems for traditional models of specific and informed consent to medical research. However, these advances also enable novel ways to securely share and analyse data. This paper introduces one of these advances-blockchain technologies-and argues that they can be used to share medical data in a secure and auditable fashion. In addition, some aspects of consent and data collection, as well as data access management and analysis, can be automated using blockchain-based smart contracts. This paper demonstrates how blockchain technologies can be used to further all three of the bioethical principles underlying consent requirements: the autonomy of patients, by giving them much greater control over their data; beneficence, by greatly facilitating medical research efficiency and by reducing biases and opportunities for errors; and justice, by enabling patients with rare or under-researched conditions to pseudonymously aggregate their data for analysis. Finally, we coin and describe the novel concept of prosent, by which we mean the blockchain-enabled ability of all stakeholders in the research process to pseudonymously and proactively consent to data release or exchange under specific conditions, such as trial completion.
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.
1. Introduction to Subject: Participation in Research Trial1.1 Relevance of the Subject Conducting clinical studies includes an obligation to publish results to participants, sponsors, colleagues, and the public (Antes, 2009). ClinicalTrials.gov lists over 304,000 studies with locations in 208 countries (ClinicalTrials, 2019). The German Register of Clinical Trials (Deutsches
Nicholas Mamo, Gillian M. Martin, Maria Desira, Bridget Ellul ยท 5 authors
Dynamic consent aims to empower research partners and facilitate active participation in the research process. Used within the context of biobanking, it gives individuals access to information and control to determine how and where their biospecimens and data should be used. We present Dwarna-a web portal for 'dynamic consent' that acts as a hub connecting the different stakeholders of the Malta Biobank: biobank managers, researchers, research partners, and the general public. The portal stores research partners' consent in a blockchain to create an immutable audit trail of research partners' consent changes. Dwarna's structure also presents a solution to the European Union's General Data Protection Regulation's right to erasure-a right that is seemingly incompatible with the blockchain model. Dwarna's transparent structure increases trustworthiness in the biobanking process by giving research partners more control over which research studies they participate in, by facilitating the withdrawal of consent and by making it possible to request that the biospecimen and associated data are destroyed.
Quality of clinical research is undermined by severe misconducts, errors, frauds, which are detrimental to the trust it should arouse. In this perspective article, we show how Blockchain may trace and control processes of Clinical Trials preventing from the above issues or at least discourage them since they would become traceable and opposable. Then, we propose a short and doable program where, amidst the complex stream of events that a Clinical Trials consist of, we select sensitive and misconduct-prone steps that could dramatically benefit from Blockchain, through either simple core features as traceability and incorruptibility of its data registration, or through more refined automation tools called Smart Contracts.
Open access
Blockchain Technology Applications and Security
Ethics in Clinical Research
Artificial Intelligence in Healthcare and Education
Wendy Charles, Natalie Marler, Lauren Long, Sean T. Manion
As clinical research moves toward real-world data capture with increased data sharing, there is a growing need for patient-centered technologies that ensure data authenticity and promote researcher and patient access. Blockchain is one of an emerging set of distributed ledger technologies with the potential to offer both research data transparency and trust, while offering robust security measures. As blockchain-based systems are being developed for clinical research applications, these systems may be required to follow state and federal research regulations, such as ethical protections for human participants and data privacy. Blockchain developers and research organizations alike are struggling to identify and interpret these regulatory requirements. Further, regulatory agencies and policymakers have not yet provided blockchain stakeholders with clear guidelines to achieve compliance. This article provides an introduction to the clinical research and health information privacy regulations in the United States as well as data design standards and electronic signature laws. We also offer recommendations for blockchain developers, researchers, and research organizations for achieving compliant blockchain solutions in clinical research.
In most regions of China, Electronic Medical Record (EMR) systems in hospitals are developed in an uncoordinated manner. Medical Insurance and Healthcare Administration are localised and organizations gather data from a functional management viewpoint without consideration of wider information sharing. Discontinuity of data resources is serious. Despite the government's repeated emphasis on EMR data integration, little progress has been made, causing inconvenience to patients, but also significantly hindering data mining.This exploratory investigation used a case study to identify bottlenecks of data integration and proposes countermeasures. Interviews were carried out with 27 practitioners from central and provincial governments, hospitals, and related enterprises in China. This research shows that EMR data collection without patients' authorization poses a major hazard to data integration. In addition, non-uniform information standards and hospitals' unwillingness to share data are also significant obstacles to integration. Moreover, friction caused by the administrative decentralization, as well as unsustainability of public finance investment, also hinders the integration of data resources.To solve these problems, first, a protocol should be adopted for multi-stakeholder participation in data collection. Administrative authorities should then co-establish information standards and a data audit mechanism. Finally, measures are proposed for expanding data integration for multiplying effectiveness and adopting the Public-Private Partnerships model.
Eric Venner, Mullai Murugan, Walker Hale, Jordan M Jones ยท 7 authors
MOTIVATION: Clinical genome sequencing laboratories return reports containing clinical testing results, signed by a board-certified clinical geneticist, to the ordering physician. This report is often a PDF, but can also be a paper copy or a structured data file. The reports are frequently modified and reissued due to changes in variant interpretation or clinical attributes. MATERIALS AND METHODS: To precisely track report authenticity, we developed ARBoR (Authenticated Resources in a Hashed Block Registry), an application for tracking the authenticity and lineage of versioned clinical reports even when they are distributed as PDF or paper copies. ARBoR tracks clinical reports as cryptographically signed hash blocks in an electronic ledger file, which is then exactly replicated to many clients. RESULTS: ARBoR was implemented for clinical reporting in the Human Genome Sequencing Center Clinical Laboratory, initially as part of the National Institute of Health's Electronic Medical Record and Genomics (eMERGE) project. CONCLUSIONS: To date, we have issued 15 205 versioned clinical reports tracked by ARBoR. This system has provided us with a simple and tamper-proof mechanism for tracking clinical reports with a complicated update history.
Major trends in healthcare and life sciences (HCLS) include huge amounts of and longitudinal patient data, policies on a patient's rights to access and control their data, a move from fee-for-service to outcome-based contracts, and regulatory and privacy requirements. Blockchain, as a distributed transactional system of record, can provide underpinnings to enable these trends and enable transformative opportunities in HCLS by providing immutable data on a shared ledger, secure and authenticated transactions, and smart contracts that can represent rules that are executed with secure transactions. We describe HCLS use cases leveraging these facets of blockchain, including patient consent and health data exchange, outcome-based contracts, next-generation clinical trials, supply chain, and payments and claims. We then describe a blockchain-based architecture and platform for enabling these use cases. Finally, we outline a realization of this architecture in a case study and outline further research topics in this domain.
Daniel R. Wong, Sanchita Bhattacharya, Atul J. Butte
Monitoring and ensuring the integrity of data within the clinical trial process is currently not always feasible with the current research system. We propose a blockchain-based system to make data collected in the clinical trial process immutable, traceable, and potentially more trustworthy. We use raw data from a real completed clinical trial, simulate the trial onto a proof of concept web portal service, and test its resilience to data tampering. We also assess its prospects to provide a traceable and useful audit trail of trial data for regulators, and a flexible service for all members within the clinical trials network. We also improve the way adverse events are currently reported. In conclusion, we advocate that this service could offer an improvement in clinical trial data management, and could bolster trust in the clinical research process and the ease at which regulators can oversee trials.