Quality Assurance In The Age Of Personalized Medicine: Challenges And Opportunities
DOI:
https://doi.org/10.22270/ajprd.v12i2.1384Abstract
The abstract of the document "Quality Assurance in the Age of Personalized Medicine" provides an overview of the challenges and opportunities presented by personalized medicine in the healthcare landscape. It discusses how the individualized nature of personalized therapies, coupled with regulatory complexities and data management issues, complicates the development, approval, and commercialization of personalized treatments. Despite these challenges, the abstract highlights the potential for innovation and advancement in quality assurance through the use of emerging technologies like artificial intelligence, machine learning, and big data analytics. These technologies can enhance diagnostic test predictability, optimize treatment selection algorithms, and improve patient stratification strategies. Furthermore, the abstract emphasizes the shift towards patient-centered care and shared decision-making, empowering patients to actively participate in their treatment journeys and fostering collaboration between patients, providers, and industry stakeholders. Overall, the abstract sets the stage for exploring the complexities and opportunities in quality assurance within the realm of personalized medicine.
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References
Adam W, Stephen J, Naylor S. Personalised medicine. Drug Discovery. 2007:19.
Savard J. Personalised medicine: a critique on the future of health care. Journal of bioethical inquiry. 2013 Jun;10:197-203.
Cutica I, Mc Vie G, Pravettoni G. Personalised medicine: the cognitive side of patients. European Journal of Internal Medicine. 2014 Oct 1;25(8):685-8.
Cruz-Correia R, Ferreira D, Bacelar G, Marques P, Maranhão P. Personalised medicine challenges: quality of data. International Journal of Data Science and Analytics. 2018 Nov;6(3):251-9.
Dhingra I, Mani N, Thakkar AR. Regulatory Aspects of Personalised Medicines. Applied Drug Research, Clinical Trials and Regulatory Affairs: Formerly Applied Clinical Research, Clinical Trials and Regulatory Affairs. 2021 Aug 1;8(2):77-83.
Ennezat PV, Cosgrove S, Bouvaist H, Marechaux S, Guerbaai RA, Le Jemtel T, Andrejak M, Vital-Durand D. From evidence-based medicine to personalized medicine, with particular emphasis on drug-safety monitoring. Archives of cardiovascular diseases. 2017 Jun 1;110(6-7):413-9.
Rajendiran K, Sridhar A, Cassinadane AV. Data Consistency, Transparency, and Privacy in Healthcare Systems Using Blockchain Technology. Blockchain Technology in Corporate Governance: Transforming Business and Industries. 2022 Oct 31:125-41.
De Palma M, Hanahan D. The biology of personalized cancer medicine: facing individual complexities underlying hallmark capabilities. Molecular oncology. 2012 Apr 1;6(2):111-27.
Goldman DP, Gupta C, Vasudeva E, Trakas K, Riley R, Lakdawalla D, Agus D, Sood N, Jena AB, Philipson TJ. The value of diagnostic testing in personalized medicine. InForum for Health Economics and Policy 2013 Sep 1 (Vol. 16, No. 2, pp. S87-S99). De Gruyter.
Prebula RJ. The Promise and Personalized Medicine: Regulatory Controls and Tort Influences in the Context of Personalized Risks and Benefits. J. Contemp. Health L. & Pol'y. 2009;26:343.
Blobel B, Lopez DM, Gonzalez C. Patient privacy and security concerns on big data for personalized medicine. Health and Technology. 2016 Jun;6:75-81.
Pavelić K, Martinović T, Kraljević Pavelić S. Do we understand the personalized medicine paradigm? Personalized medicine marks the beginning of a new attitude in medicine. EMBO reports. 2015 Feb;16(2):133-6.
Knowles L, Luth W, Bubela T. Paving the road to personalized medicine: recommendations on regulatory, intellectual property and reimbursement challenges. Journal of Law and the Biosciences. 2017 Dec;4(3):453-506.
Moumtzoglou AS, editor. Quality Assurance in the Era of Individualized Medicine. IGI Global; 2019 Nov 29.
Jain KK, Jain KK. Legal & Regulatory Aspects of Personalized Medicine. Textbook of Personalized Medicine. 2021:683-700.
Morganti S, Tarantino P, Ferraro E, D’Amico P, Duso BA, Curigliano G. Next generation sequencing (NGS): a revolutionary technology in pharmacogenomics and personalized medicine in cancer. Translational research and onco-omics applications in the era of cancer personal genomics. 2019:9-30.
Yan Q. Translational bioinformatics and systems biology approaches for personalized medicine. Systems biology in drug discovery and development: Methods and protocols. 2010:167-78.
Benz MR, Vargas HA, Sala E. Functional MR imaging techniques in oncology in the era of personalized medicine. Magnetic Resonance Imaging Clinics. 2016 Feb 1;24(1):1-0.
Cecchin E, Stocco G. Pharmacogenomics and personalized medicine. Genes. 2020 Jun 22;11(6):679.
Sitapati A, Kim H, Berkovich B, Marmor R, Singh S, El‐Kareh R, Clay B, Ohno‐Machado L. Integrated precision medicine: the role of electronic health records in delivering personalized treatment. Wiley Interdisciplinary Reviews: Systems Biology and Medicine. 2017 May;9(3):e1378.
Chattu VK. A review of artificial intelligence, big data, and blockchain technology applications in medicine and global health. Big Data and Cognitive Computing. 2021 Sep 6;5(3):41.
Khan NA, Peterson JF. A surveillance tool to support quality assurance and research in personalized medicine. InAMIA Annual Symposium Proceedings 2011 (Vol. 2011, p. 701). American Medical Informatics Association.
Thapa C, Camtepe S. Precision health data: Requirements, challenges and existing techniques for data security and privacy. Computers in biology and medicine. 2021 Feb 1;129:104130.
Wang H, Feng D, Liu Y. Personalized medicine with advanced analytics. Real-World Evidence in Medical Product Development. 2023 May 12:289-320.
Idelhauser J, Humm BG, Beez U, Walsh P. A clinical decision support system for personalized medicine. CERC2016. 2016 Sep 23:34.
Cordeiro JV. Ethical and legal challenges of personalized medicine: Paradigmatic examples of research, prevention, diagnosis and treatment. Revista Portuguesa de Saúde Pública. 2014 Jul 1;32(2):164-80.
Regniault A, Kupecz A, Gavey M, Mignolet O, De Carlo P, Meyer P, Bailey S. Legal and ethical concerns in personalized medicine: a European perspective. Personalized Medicine. 2009 Sep;6(5):517-28.
Krasna MJ. Collaboration as a foundation for advancing research in personalized medicine in cancer care. Personalized Medicine. 2010 Nov;7(6):669-75.
Browman GP, Vollmann J, Virani A, Schildmann J. Improving the quality of ‘personalized medicine’research and practice: through an ethical lens. Personalized Medicine. 2014 Jun;11(4):413-23.
Ahmed Z. Multi-omics strategies for personalized and predictive medicine: past, current, and future translational opportunities. Emerging topics in life sciences. 2022 Mar 2;6(2):215-25.
Mystridis GA, Chatzopoulou F, Patrinos GP, Vizirianakis IS. Artificial Intelligence/Machine Learning and mechanistic modeling approaches as translational tools to advance personalized medicine decisions. Advances in Molecular Pathology. 2022 Nov 1;5(1):131-9.
Gawai AA, Das S, Magar SK. Novus International Journal of Analytical Innovations.
Busnatu ȘS, Niculescu AG, Bolocan A, Andronic O, Pantea Stoian AM, Scafa-Udriște A, Stănescu AM, Păduraru DN, Nicolescu MI, Grumezescu AM, Jinga V. A review of digital health and biotelemetry: modern approaches towards personalized medicine and remote health assessment. Journal of Personalized Medicine. 2022 Oct 5;12(10):1656.
Thomas DC. What does “Precision Medicine” have to say about prevention?. Epidemiology. 2017 Jul 1;28(4):479-83.
Dickmann LJ, Ware JA. Pharmacogenomics in the age of personalized medicine. Drug Discovery Today: Technologies. 2016 Sep 1;21:11-6.
Vogenberg FR, Barash CI, Pursel M. Personalized medicine: part 2: ethical, legal, and regulatory issues. Pharmacy and therapeutics. 2010 Nov;35(11):624.
Gawai AA, Das S, Parida P, Biyani K. Drug Design & Drug Formulation.
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