Advanced Digital System for International Collaboration on Biosample-Oriented Research: A Multicriteria Query Tool for Real-Time Biosample and Patient Cohort Searches
Abstract
:1. Introduction
2. Materials and Methods
2.1. Project Design and Development
2.2. User Assessment
2.3. Data Mining
2.4. Security and Compliance
- Risk Assessment and Management: Identifies threats, vulnerabilities, and potential impacts on information assets;
- Comprehensive Security Controls: Includes access control, network security, incident management, and monitoring;
- Incident Management: Detects, reports, assesses, and responds to information security incidents;
- Continuous Improvement: Involves processes for reviewing, updating, and enhancing the information security management system;
- Compliance and Legal Requirements: Ensures adherence to relevant laws, regulations, and contractual requirements related to information security;
- Encryption: A security control to protect sensitive data, outlining requirements for key management, algorithms, and cryptographic controls to maintain confidentiality and integrity;
- Data Accuracy and Integrity Policies: Ensures reliability and accuracy of personal data;
- Privacy by Design and Default Principles: Facilitates the integration of privacy considerations into system design and development. This includes privacy-enhancing technologies, risk-based approaches, and privacy impact assessments;
- Data Protection Impact Assessment Methodologies: Used for assessing privacy risks associated with personal data processing.
- Authentication/Encryption Module: Handles authentication and encryption of stored and transmitted data;
- Permission Handling Module: Manages user permissions for accessing and modifying data stored in the Data Layer;
- Data Sharing Agreement Module: Facilitates data sharing agreements between various actors in the research ecosystem.
2.5. Data Transfer and Export
2.6. Technical Implementation
3. System Architecture, Functionalities, and User Experience
3.1. Overview of Platform and Architecture
- User Login: Users authenticate and submit their credentials for data access, based on their biobank and network permissions;
- Query Submission: Users select query criteria from a user-friendly interface and submit the query;
- Data Processing: The system processes the query, using data mining and real-time analytics to search across the network;
- Results Output: The system generates a list of available biosamples, patient profiles, and associated data, clustered by adoption rates.
3.2. Real-Time Dynamic E-Consent (DRT E-Consent) System
3.3. User Interface/User Experience (UX)
- Personnel permission handling;
- Managing research-related data entries;
- Audits of history per user ID;
- Real-time dynamic multicriteria queries.
4. Discussion
- Biosamples and associated patient data are stored in multiple, siloed biobanks and clinical registries, making data retrieval slow and inefficient;
- Researchers face difficulties tracking and updating consent, leading to potential legal and ethical issues;
- Existing systems lack advanced search functionalities, making it difficult to refine sample selection based on multiple criteria.
- Researchers log in to the platform via a secure authentication system;
- Using the multi-criteria query tool, they filter samples based on genetic markers, treatment response, demographic factors, and pre-analytical conditions;
- The system processes the query in real time, retrieving data from multiple sources while maintaining data integrity;
- The DRT e-consent system provides up-to-date information on donor consent status;
- Automated alerts notify researchers if additional consent is needed, ensuring compliance with ethical guidelines;
- A universal dashboard provides aggregated insights into available biosamples and patient cohorts across regions within the associated network;
- Query history is logged for reproducibility, enhancing research credibility and compliance tracking.
- Public health organizations struggle to rapidly locate biosamples relevant to ongoing outbreaks due to disconnected databases;
- Patient consent preferences change frequently, but existing systems fail to update researchers in real time;
- Researchers cannot easily refine searches by multiple parameters, making it difficult to identify the most relevant biosamples for surveillance studies.
- Researchers log in and submit a multi-criteria query to filter samples based on viral strain, symptom severity, patient demographics, and hospitalization history;
- The system searches multiple biobanks in real time, providing ranked results based on clustering thresholds (50%, 70%, and 100%);
- The DRT E-Consent system updates patient consent status dynamically;
- Researchers receive instant notifications if a patient withdraws their consent, preventing unauthorized sample usage;
- A universal dashboard provides regional outbreak statistics, helping policymakers allocate resources efficiently.
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- Expanding Modular Capabilities: Incorporating AI-driven analytics and genomic data repositories will enhance the platform’s ability to support cutting-edge research;
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- Strengthening Interoperability: Additional compatibility with emerging international standards will facilitate broader adoption, particularly in regions with distinct regulatory frameworks;
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- Training and Education Programs: Developing comprehensive training modules will help stakeholders optimize platform usage and encourage widespread participation in the research community;
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- Strengthening International Collaborations: Regulatory frameworks will also be key to expanding the platform’s reach and ensuring compliance across diverse legal landscapes;
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- Incorporating Blockchain Technology: Consent management adds an extra layer of security and transparency, ensuring that all consent modifications are immutable and verifiable;
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- Pilot Testing: Ensuring the seamless handling of multi-modal data, engaging a spectrum of stakeholders (genomic, clinical, imaging, etc.), and gathering feedback from end-users for validation and improvement.
5. Conclusions
Author Contributions
Funding
Data Availability Statement
Conflicts of Interest
References
- Ward, C.L.; Shaw, D.; Sprumont, D.; Sankoh, O.; Tanner, M.; Elger, B. Good collaborative practice: Reforming capacity building governance of international health research partnerships. Glob. Health 2018, 14, 1. [Google Scholar] [CrossRef]
- Saenz, C.; Krahn, T.M.; Smith, M.J.; Haby, M.M.; Carracedo, S.; Reveiz, L. Advancing collaborative research for health: Why does collaboration matter? BMJ Glob. Health 2024, 9, e014971. [Google Scholar] [CrossRef]
- Belmont, J.W.; Hardenbol, P.; Willis, T.D.; Yu, F.; Yang, H.; Chang, L.Y.; Huang, W.; Liu, B.; Shen, Y.; Tam, P.K.H.; et al. The International HapMap Project. Nature 2003, 426, 789–796. [Google Scholar] [CrossRef]
- Yao, B. International Research Collaboration: Challenges and Opportunities. J. Diagn. Med. Sonogr. 2021, 37, 107–108. [Google Scholar] [CrossRef]
- Nott, M.; Schmidt, D.; Thomas, M.; Reilly, K.; Saksena, T.; Kennedy, J.; Hawke, C.; Christian, B. Collaborations between health services and educational institutions to develop research capacity in health services and health service staff: A systematic scoping review. BMC Health Serv. Res. 2024, 24, 1363. [Google Scholar] [CrossRef]
- Dixon-Woods, M.; Foy, C.; Hayden, C.; Al-Shahi Salman, R.; Tebbutt, S.; Schroter, S. Can an ethics officer role reduce delays in research ethics approval? A mixed-method evaluation of an improvement project. BMJ Open 2016, 6, e011973. [Google Scholar] [CrossRef]
- Canario Guzmán, J.A.; Espinal, R.; Báez, J.; Melgen, R.E.; Rosario, P.A.P.; Mendoza, E.R. Ethical challenges for international collaborative research partnerships in the context of the Zika outbreak in the Dominican Republic: A qualitative case study. Health Res. Policy Syst. 2017, 15, 82. [Google Scholar] [CrossRef]
- Huynh, T. Collaborative research in healthcare: Uncovering the impact of industry collaboration on the service innovativeness of university hospitals. J. Technol. Transf. 2024, 50, 1–28. [Google Scholar] [CrossRef]
- Li, X.; Cong, Y. Exploring barriers and ethical challenges to medical data sharing: Perspectives from Chinese researchers. BMC Med. Ethics 2024, 25, 132. [Google Scholar] [CrossRef]
- Kosiol, J.; Silvester, T.; Cooper, H.; Alford, S.; Fraser, L. Revolutionising health and social care: Innovative solutions for a brighter tomorrow—A systematic review of the literature. BMC Health Serv. Res. 2024, 24, 809. [Google Scholar] [CrossRef]
- Dusdal, J.; Powell, J.J.W. Benefits, Motivations, and Challenges of International Collaborative Research: A Sociology of Science Case Study. Sci. Public Policy 2021, 48, 235–245. [Google Scholar] [CrossRef]
- Figueiredo, M.S.N.; Pereira, A.M. Managing Knowledge–The Importance of Databases in the Scientific Production. Procedia Manuf. 2017, 12, 166–173. [Google Scholar] [CrossRef]
- Mikhael, E.M.; Al-Jumaili, A.A.; Jamal, M.Y.; Abdulazeez, Z.D. Current status and perceived challenges of collaborative research in a leading pharmacy college in Iraq: A qualitative study. BMC Med. Educ. 2025, 25, 61. [Google Scholar] [CrossRef]
- Muenzen, K.D.; Amendola, L.M.; Kauffman, T.L.; Mittendorf, K.F.; Bensen, J.T.; Chen, F.; Green, R.; Powell, B.C.; Kvale, M.; Angelo, F.; et al. Lessons learned and recommendations for data coordination in collaborative research: The CSER consortium experience. HGG Adv. 2022, 3, 100120. [Google Scholar] [CrossRef]
- Navale, V.; von Kaeppler, D.; McAuliffe, M. An overview of biomedical platforms for managing research data. J. Data Inf. Manag. 2021, 3, 21–27. [Google Scholar] [CrossRef]
- Winickoff, D.E.; Kreiling, L.; Borowiecki, M.; Garden, H.; Philp, J. Collaborative Platforms for Emerging Technology: Creating Convergence Spaces. Available online: http://www.oecd.org/termsandconditions (accessed on 5 February 2025).
- Metabio–Metabio. Available online: https://metab.io/ (accessed on 22 April 2025).
- Dowling, N.M.; Bolt, D.M.; Deng, S.; Li, C. Measurement and control of bias in patient reported outcomes using multidimensional item response theory. BMC Med. Res. Methodol. 2016, 16, 63. [Google Scholar] [CrossRef]
- Dankar, F.K.; Gergely, M.; Dankar, S.K. Informed Consent in Biomedical Research. Comput. Struct. Biotechnol. J. 2019, 17, 463–474. [Google Scholar] [CrossRef]
- Inan, O.T.; Tenaerts, P.; Prindiville, S.A.; Reynolds, H.R.; Dizon, D.S.; Cooper-Arnold, K.; Turakhia, M.; Pletcher, M.J.; Preston, K.L.; Krumholz, H.M.; et al. Digitizing clinical trials. NPJ Digit. Med. 2020, 3, 1–7. [Google Scholar] [CrossRef]
- Kazmierska, J.; Hope, A.; Spezi, E.; Beddar, S.; Nailon, W.H.; Osong, B.; Ankolekar, A.; Choudhury, A.; Dekker, A.; Redalen, K.R.; et al. From multisource data to clinical decision aids in radiation oncology: The need for a clinical data science community. Radiother. Oncol. 2020, 153, 43–54. [Google Scholar] [CrossRef]
- Matthews, K.R.W.; Yang, E.; Lewis, S.W.; Vaidyanathan, B.R.; Gorman, M. International scientific collaborative activities and barriers to them in eight societies. Account. Res. 2020, 27, 477–495. [Google Scholar] [CrossRef]
- Swift, B.; Jain, L.; White, C.; Chandrasekaran, V.; Bhandari, A.; Hughes, D.A.; Jadhav, P.R. Innovation at the Intersection of Clinical Trials and Real-World Data Science to Advance Patient Care. Clin. Transl. Sci. 2018, 11, 450–460. [Google Scholar] [CrossRef]
- Torab-Miandoab, A.; Samad-Soltani, T.; Jodati, A.; Rezaei-Hachesu, P. Interoperability of heterogeneous health information systems: A systematic literature review. BMC Med. Inform. Decis. Mak. 2023, 23, 18. [Google Scholar] [CrossRef]
- Blumenthal, S. Improving Interoperability between Registries and EHRs. AMIA Summits Transl. Sci. Proc. 2018, 2018, 20. [Google Scholar] [PubMed] [PubMed Central]
- Kim, E.; Rubinstein, S.M.; Nead, K.T.; Wojcieszynski, A.P.; Gabriel, P.E.; Warner, J.L. The Evolving Use of Electronic Health Records (EHR) for Research. Semin. Radiat. Oncol. 2019, 29, 354–361. [Google Scholar] [CrossRef]
- Yen, P.Y.; McAlearney, A.S.; Sieck, C.J.; Hefner, J.L.; Huerta, T.R. Health Information Technology (HIT) Adaptation: Refocusing on the Journey to Successful HIT Implementation. JMIR Med. Inform. 2017, 5, e7476. [Google Scholar] [CrossRef]
- Vorisek, C.N.; Lehne, M.; Klopfenstein, S.A.I.; Mayer, P.J.; Bartschke, A.; Haese, T.; Thun, S. Fast Healthcare Interoperability Resources (FHIR) for Interoperability in Health Research: Systematic Review. JMIR Med. Inform. 2022, 10, e35724. [Google Scholar] [CrossRef]
- ISO/IEC 27001:2022—Information Security Management Systems. Available online: https://www.iso.org/standard/27001 (accessed on 22 April 2025).
- General Data Protection Regulation (GDPR) Compliance Guidelines. 2021. Available online: https://gdpr.eu/ (accessed on 22 April 2025).
- HIPAA Home|HHS.gov. Available online: https://www.hhs.gov/programs/hipaa/index.html (accessed on 22 April 2025).
- Chillotti, I.; Gama, N.; Georgieva, M.; Izabachène, M. TFHE: Fast Fully Homomorphic Encryption Over the Torus. J. Cryptol. 2020, 33, 34–91. [Google Scholar] [CrossRef]
- Dingledy, F.W.; Matamoros, A.B. What Is Digital Rights Management? 2016. Available online: https://scholarship.law.wm.edu/libpubs/122 (accessed on 25 May 2021).
- Ivanova, D.; Katsaounis, P. Real-Time Dynamic Tiered e-Consent: A Novel Tool for Patients’ Engagement and Common Ontology System for the Management of Medical Data. Innov. Digit. Health Diagn. Biomark. 2021, 1, 45–49. [Google Scholar] [CrossRef]
- Hu, V.C.; Ferraiolo, D.; Kuhn, R.; Schnitzer, A.; Sandlin, K.; Miller, R.; Scarfone, K. NIST Special Publication 800-162 Guide to Attribute Based Access Control (ABAC) Definition and Considerations. NIST Spec. Publ. 2014, 800, 1–54. [Google Scholar] [CrossRef]
- Lapatas, V.; Stefanidakis, M.; Jimenez, R.C.; Via, A.; Schneider, M.V. Data integration in biological research: An overview. J. Biol. Res. 2015, 22, 9. [Google Scholar] [CrossRef]
- Lin, D.; McAuliffe, M.; Pruitt, K.D.; Gururaj, A.; Melchior, C.; Schmitt, C.; Wright, S.N. Biomedical Data Repository Concepts and Management Principles. Sci. Data 2024, 11, 622. [Google Scholar] [CrossRef]
- Shanahan, H.; Bezuidenhout, L. Rethinking the A in FAIR Data: Issues of Data Access and Accessibility in Research. Front. Res. Metr. Anal. 2022, 7, 912456. [Google Scholar] [CrossRef]
- Jacobson, L.P.; Parker, C.B.; Cella, D.; Mroczek, D.K.; Lester, B.M.; Smith, P.B.; Newby, K.L.; Gershon, R.; Cella, D. Approaches to protocol standardization and data harmonization in the ECHO-wide cohort study. Pediatr. Res. 2024, 95, 1726. [Google Scholar] [CrossRef]
- Facile, R.; Elizabeth Muhlbradt, E.; Gong, M.; Li, Q.-N.; Popat, V.B.; Pétavy, F.; Cornet, R.; Ruan, Y.; Koide, D.; Saito, I.; et al. The Use of CDISC Standards for Real-World Data (RWD): Expert Perspectives from a Qualitative Delphi Survey. JMIR Med. Inform. 2022, 10, e30363. [Google Scholar] [CrossRef]
- Kush, R.D.; Warzel, D.; Kush, M.A.; Sherman, A.; Navarro, E.A.; Fitzmartin, R.; Pétavy, F.; Galvez, J.; Becnel, L.B.; Zhou, F.L.; et al. FAIR data sharing: The roles of common data elements and harmonization. J. Biomed. Inform. 2020, 107, 103421. [Google Scholar] [CrossRef]
- Hoffman, N.; Alkhatib, R.; Gaede, K.I. Data Management in Biobanking: Strategies, Challenges, and Future Directions. BioTech 2024, 13, 34. [Google Scholar] [CrossRef]
- Jacquier, E.; Laurent-Puig, P.; Badoual, C.; Burgun, A.; Mamzer, M.F. Facing new challenges to informed consent processes in the context of translational research: The case in CARPEM consortium. BMC Med. Ethics 2021, 22, 21. [Google Scholar] [CrossRef]
- Dankar, F.K.; Ptitsyn, A.; Dankar, S.K. The development of large-scale de-identified biomedical databases in the age of genomics-principles and challenges. Hum. Genom. 2018, 12, 19. [Google Scholar] [CrossRef]
- Asiimwe, R.; Lam, S.; Leung, S.; Wang, S.; Wan, R.; Tinker, A.; McAlpine, J.N.; Woo, M.M.M.; Huntsman, D.G.; Talhouk, A. From biobank and data silos into a data commons: Convergence to support translational medicine. J. Transl. Med. 2021, 19, 493. [Google Scholar] [CrossRef]
- Rajendran, S.; Pan, W.; Sabuncu, M.R.; Chen, Y.; Zhou, J.; Wang, F. Learning across diverse biomedical data modalities and cohorts: Challenges and opportunities for innovation. Patterns 2024, 5, 100913. [Google Scholar] [CrossRef]
- Green, A.K.; Reeder-Hayes, K.E.; Corty, R.W.; Basch, E.; Milowsky, M.I.; Dusetzina, S.B.; Bennett, A.V.; Wood, W.A. The project data sphere initiative: Accelerating cancer research by sharing data. Oncologist 2015, 20, 464-e20. [Google Scholar] [CrossRef]
- Ashley, E.A. The precision medicine initiative: A new national effort. JAMA 2015, 313, 2119–2120. [Google Scholar] [CrossRef]
- Shin, S.H.; Bode, A.M.; Dong, Z. Precision medicine: The foundation of future cancer therapeutics. NPJ Precis. Oncol. 2017, 1, 12. [Google Scholar] [CrossRef]
Needs | Constraints |
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Rapid Access to High-Quality Samples and Data
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Collaboration and Interdisciplinary Research
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Transparent Reporting and Accountability
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Technological Advancements and Data Management
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Research Reproducibility and Transparency
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Category | Support | Impact |
---|---|---|
Society | Advances biomedical research | Improves disease detection and prevention. |
Contributes to personalized medicine | Reduces adverse drug reactions and enhances patient outcomes. | |
Ensures research includes diverse populations. | Supports equitable healthcare | |
Aids in large-scale epidemiological studies. | Improves public health policies and responses to global health crises. | |
Enhances the ability to track and manage disease outbreaks, including pandemics. | Improves health outcomes and societal cohesion. | |
Researchers | Breaks down data silos. | Enables seamless collaboration across institutions and disciplines. |
Provides a scalable and secure infrastructure. | Efficient management of complex biomedical datasets. | |
Integrates multi-modal data (genomics, clinical records, imaging, etc.). | Enhances research accuracy and efficacy. | |
Provides advanced analytics. | Accelerates drug discovery and biomarker identification. | |
Enrichment of biosample-related data | Reduced time and costs associated with clinical trials, expediting the translation of research into real-world treatments | |
Healthcare | Integrates genomic and clinical data for tailored treatments | Enables precision medicine. |
Improves disease surveillance and outbreak prediction. | Enhances public health preparedness. | |
Real-time, evidence-based insights | Empowers clinicians with for better decision making. | |
Enhances pharmaceutical innovation. | Faster drug discovery and development. | |
Optimizes resource allocation and patient care strategies | Supports data-driven healthcare policies |
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Share and Cite
Fridas, A.; Bourouliti, A.; Touramanidou, L.; Ivanova, D.; Votis, K.; Katsaounis, P. Advanced Digital System for International Collaboration on Biosample-Oriented Research: A Multicriteria Query Tool for Real-Time Biosample and Patient Cohort Searches. Computers 2025, 14, 157. https://doi.org/10.3390/computers14050157
Fridas A, Bourouliti A, Touramanidou L, Ivanova D, Votis K, Katsaounis P. Advanced Digital System for International Collaboration on Biosample-Oriented Research: A Multicriteria Query Tool for Real-Time Biosample and Patient Cohort Searches. Computers. 2025; 14(5):157. https://doi.org/10.3390/computers14050157
Chicago/Turabian StyleFridas, Alexandros, Anna Bourouliti, Loukia Touramanidou, Desislava Ivanova, Kostantinos Votis, and Panagiotis Katsaounis. 2025. "Advanced Digital System for International Collaboration on Biosample-Oriented Research: A Multicriteria Query Tool for Real-Time Biosample and Patient Cohort Searches" Computers 14, no. 5: 157. https://doi.org/10.3390/computers14050157
APA StyleFridas, A., Bourouliti, A., Touramanidou, L., Ivanova, D., Votis, K., & Katsaounis, P. (2025). Advanced Digital System for International Collaboration on Biosample-Oriented Research: A Multicriteria Query Tool for Real-Time Biosample and Patient Cohort Searches. Computers, 14(5), 157. https://doi.org/10.3390/computers14050157