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Re-engineering Clinical Trial Management System Using Blockchain Technology

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Focusing on health policy, telehealth and virtual care, blockchain and edge technologies, **ConV2X 2021** is the premier destination community identifying new and cost effective paths forward through real world evidence, strategy, operations, research & trends.

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Focusing on health policy, telehealth and virtual care, blockchain and edge technologies, ConV2X 2021 is the premier destination community identifying new and cost effective paths forward through real world evidence, strategy, operations, research & trends.

technical paper

Substandard and falsified (SF) pharmaceuticals account for an estimated 10% of the pharmaceutical supply chain in low- and middle-income countries (LMICs), where a lack of regulatory and laboratory resources limits the ability to conduct effective post-market surveillance and allows SF products to penetrate the supply chain. The Distributed Pharmaceutical Analysis Laboratory (DPAL) was established in 2014 to expand testing of pharmaceutical dosage forms sourced from LMICs; DPAL is an alliance of academic institutions throughout the United States and abroad that provides high quality, validated chemical analysis of pharmaceutical dosage forms sourced from partners in LMICs. Results from analysis are reported to relevant regulatory agencies and are used to inform purchasing decisions made by in-country stakeholders. As the DPAL program has expanded to testing more than 1000 pharmaceutical dosage forms annually, challenges have surfaced regarding data management and sample tracking. Here, we describe a pilot project between DPAL and ARTiFACTs that applies blockchain to organize and manage key data generated during the DPAL workflow, including a sample’s progress through the workflow, its physical location, provenance of metadata, and lab reputability. Recording time and date stamps with this data will create a permanent and verifiable chain-of-custody for samples. This secure, distributed ledger will be linked to an easy-to-use dashboard, allowing stakeholders to view results and experimental details for each sample in real time and verify the integrity of DPAL analysis data. Introducing this blockchain-based system as a pilot will allow us to test the technology with real users analyzing real samples. Feedback from users will be recorded and necessary adjustments will be made to the system before the implementation of blockchain across all DPAL sites. Anticipated benefits of implementing blockchain for managing DPAL data include efficient management for routing work, increasing throughput, creating a chain of custody for samples and their data in alignment with the distributed nature of DPAL, and using the analysis results to detect patterns of quality within and across brands of products and develop enhanced sampling techniques and best practices.

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The annual ConV2X is a leading international health tech symposium driving real world evidence, strategy, research, operations and trends to create a blueprint for a new digital health era. The 2021 symposium featured a scientific program of academic/research presentations in addition to business and industry talks. The research track focused on exploring and sharing developments in blockchain and emerging technologies in health and clinical medicine. Submissions were based on original research, conceptual frameworks, proposed applications, position papers, case studies, and real-world implementation. Selection was based on a peer-review process. Faculty, students, and industry researchers were encouraged to submit abstracts to present ideas before an informed and knowledgeable audience of industry leaders, policy makers, funders, and researchers.

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The annual ConV2X is a leading international health tech symposium driving real world evidence, strategy, research, operations and trends to create a blueprint for a new digital health era. The 2021 symposium fetured a scientific program of academic/research presentations in addition to business and industry talks. The research track focused on exploring and sharing developments in blockchain and emerging technologies in health and clinical medicine. Submissions were based on original research, conceptual frameworks, proposed applications, position papers, case studies, and real-world implementation. Selection was based on a peer-review process. Faculty, students, and industry researchers were encouraged to submit abstracts to present ideas before an informed and knowledgeable audience of industry leaders, policy makers, funders, and researchers.

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Background: The current healthcare ecosystem in the United States is plagued by inefficiencies in transitions of patient care between healthcare providers due in large part to a lack of interoperability among the many electronic medical record (EMR) systems that exist today. Both providers and patients experience significant frustration due to the negative effects of increased costs, unnecessary administrative burden, and duplication of services that occur because of data fragmentation in the system. Blockchain technology provides a solution to mitigate or eliminate these gaps by allowing for healthcare information exchange that is distributed, auditable, immutable, and respectful of patient autonomy. Our multidisciplinary team identified key tasks required for a transition of care to design and develop a blockchain application, MediLinker, that served as a patient-centric identity management system to address the issues of data fragmentation ultimately allowing for the delivery of high value care.



Methods: The MediLinker application was evaluated for its ability to accomplish various key tasks needed for a successful transition of patient care in an outpatient setting. Our team created twenty unique patient use cases covering a diversity of medical needs and social circumstances that were played out by participants who were asked to perform various tasks as they received case across a simulated healthcare ecosystem composed of four clinics, a research institution, and other ancillary public services. Tasks included, but were not limited to, clinic enrollment, verification of identity, medication reconciliation, sharing insurance and billing information, and updating demographic information. With this iteration of MediLinker, we specifically focused on the functionality of Guardianship and patient revocation of healthcare information. Additionally, throughout the simulation we surveyed participant perceptions regarding the use of MediLinker and blockchain technology to better ascertain comfortability and usability of the application.



Results: Quantitative evaluation of simulation results revealed that MediLinker was able to successfully accomplish all seven clinical scenarios tested across the twenty patient use cases. MediLinker successfully achieved its goal of patient-centered interoperability as participants transitioned their simulated healthcare data, including COVID-19 vaccination status and current medications, across the four clinic sites and research institution. In addition to completing all key tasks designated, all eligible participants were able to enroll with and subsequently revoke data access with our simulated research site. A high degree of data accuracy was noted with most errors occurring due to inaccurate data entry from user input. Our qualitative analysis of user perceptions indicated that comfortability and trust with blockchain technology, such as MediLinker, grew with increased education and exposure to such technology.



Conclusion: The ubiquitous problem of data fragmentation in our current healthcare ecosystem has placed considerable strain on providers and patients alike. Blockchain applications for health identity management, such as MediLinker, provide a viable solution to stem the inefficiencies that exist today. The interoperability that MediLinker provided across our simulated healthcare system has the potential to improve transitions of care by sharing key aspects of healthcare information in a timely, secure, and patent-centric fashion allowing for the delivery of consistent personalized high-value care. Blockchain technologies appear to face similar challenges to widespread adoption as other novel interventions, namely recognition, trust, and usability. Further development and scaling are required for such technology to realize its full potential in the real-world and transform the practice of modern healthcare.

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Re-engineering Clinical Trial Management System Using Blockchain Technology

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