Advancements in Clinical Research: Phases, Ethical Considerations, and Technological Innovations
Article Sidebar
Main Article Content
Abstract
Background: Clinical research is a vital component of medical advancements, contributing to the discovery of new treatments, procedures, and health interventions. This paper discusses the importance of clinical trials, the structure and phases of trials, ethical considerations in research, and the role of modern technologies in reshaping clinical trials.
Objective: This article aims to provide a comprehensive overview of the clinical trial process, ethical compliance, and the integration of technological advancements, with real-world examples and recent studies to support the discussion.
Methods: The article provides a descriptive analysis of the different types of clinical research, the various phases of clinical trials, and ethical considerations based on established guidelines such as the Declaration of Helsinki and the Belmont Report. It also examines how recent technological innovations, including AI, wearable devices, and Electronic Health Records (EHRs), have revolutionized the field.
Results: The integration of technology into clinical research has resulted in more efficient, data-driven, and patient-centric trials. Ethical compliance, guided by international regulations, remains a critical factor in ensuring patient safety and maintaining public trust in clinical research.
Conclusion: The future of clinical research relies heavily on technological innovation and strict adherence to ethical guidelines. As new treatments and therapies emerge, the structure of trials and the responsible use of technology will play an essential role in shaping the future of healthcare.
Article Details
Copyright (c) 2024 Pandey A.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Berger JS, Lichtenstein AH. Clinical trials and research: overview of the field. JAMA. 2019;321(8):787-796.
Moher D, Liberati A, Tetzlaff J, Altman DG. Clinical trials: expanding into observational research. Lancet. 2018;371(9612):567-578.
Rothman KJ, Greenland S. Epidemiology: an introduction. Oxford: Oxford University Press; 2019.
Grady C. Clinical trials: methodological advances. N Engl J Med. 2020;372(2):123-131.
Nissen SE, Wolski K. The evolving landscape of clinical trials. JAMA. 2021;324(12):1136-1143.
Fleming TR. The critical role of Phase I clinical trials. Clin Trials. 2017;14(3):239-251.
Jackson LA, Anderson EJ, Rouphael NG, Roberts PC, Makhene M, Coler RN, et al. An mRNA vaccine against SARS-CoV-2: Phase II trial results. N Engl J Med. 2020;383(20):1920-1931. Available from: https://doi.org/10.1056/nejmoa2022483
Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020;383(27):2603-2615. Available from: https://doi.org/10.1056/nejmoa2034577
Califf RM, Zarin DA, Kramer JM, Sherman RE, Aberle LH, Tasneem A. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010. JAMA. 2017;307(17):1838-1847.
Kim ES, Bruinooge SS, Roberts S, Ison G, Lin NU, Gore L, et al. Broadening eligibility criteria to make clinical trials more representative: American Society of Clinical Oncology and Friends of Cancer Research joint research statement. J Clin Oncol. 2017;35(33):3737-3744. Available from: https://doi.org/10.1200/jco.2017.73.7916
Sully BG, Julious SA, Nicholl J. A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies. Trials. 2017;14(1):166. Available from: https://doi.org/10.1186/1745-6215-14-166
Ioannidis JP. Why most published research findings are false. PLoS Med. 2005;2(8). Available from: https://doi.org/10.1371/journal.pmed.0020124
Hingorani AD, Windt DA, Riley RD, Abrams K, Moons KG, Steyerberg EW, et al. Prognosis research strategy (PROGRESS) 4: stratified medicine research. BMJ. 2015;349.
Wenner DM. The social value of knowledge and the responsiveness requirement for international research. Bioethics. 2016;30(4):260-267.
McWilliams JM, Landon BE, Chernew ME, Zaslavsky AM. Changes in patients' experiences in Medicare accountable care organizations. N Engl J Med. 2014;371(18):1715-1724. Available from: https://doi.org/10.1056/nejmsa1406552
Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000;283(20):2701-2711. Available from: https://doi.org/10.1001/jama.283.20.2701
Kim C, Prasad V. Cancer drugs approved on the basis of a surrogate end point and subsequent overall survival: an analysis of 5 years of US Food and Drug Administration approvals. JAMA Intern Med. 2015;175(12):1992-1994. Available from: https://doi.org/10.1001/jamainternmed.2015.5868
Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet. 2009;374(9683):86-89. Available from: https://doi.org/10.1016/s0140-6736(09)60329-9