Decentralized Clinical Trials – Current Environment, Potential Barriers and Facilitators for Implementation and Risk Mitigation: A Review of the Literature
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Khozin S, Coravos A. Decentralized trials in the age of real-world evidence and inclusivity in clinical investigations. Clin Pharm & Therapeutics 2019; DOI: 10.1002/cpt.1441.Search in Google Scholar
Apostolaros M, Babaian D, Corneli A et al. Legal, regulatory, and practical issues to consider when adopting decentralized clinical trials: Recommendations from the Clinical Trials Transformation Initiative. Therapeutic Innovation and Regulatory Science 2020; 54:779-787.Search in Google Scholar
Thomas L, Capistrant G. 50 State telemedicine gaps analysis: physician practice standards and licensure. Washington DC: American Telemedicine Association; 2017.Search in Google Scholar
Center for Connected Health Policy. State Telehealth Laws and Reimbursement Policies: a comprehensive scan of the 50 states and the district of Columbia. Public Health Institute; 2018.Search in Google Scholar
Cwiklicki M, Schiavone F, Klich J et al. Antecedents of use of e-health services in Central Eastern Europe: a qualitative comparative analysis. BMC Health Services Research 2020; 20; 171.Search in Google Scholar
Pham MT, Rajić A, Greig JD, et al. A scoping review of scoping reviews: advancing the approach and enhancing the consistency. Research Synthesis Methods, 2014, 5(4) Available at http://onlinelibrary.wiley.com/doi/10.1002/jrsm.1123/ pdf (Accessed 20th August 2021).Search in Google Scholar
Arksey H, O’Malley L. Scoping studies: towards a methodological framework, International Journal of Social Research Methodology; 2005, 8(1):19-32.Search in Google Scholar
Levac D, Colquhoun H, and O’Brien K. Scoping studies: advancing the methodology. Implementation Science, 2010, 5(1):69 doi: 10.1186/1748-5908-5-69.Search in Google Scholar
COVID-19 and clinical trials: The Medidata perspective, Medidata Solutions, May 4, 2020, medidata.com.Search in Google Scholar
McKinsey & Company. No place like home? Stepping up the decentralization of clinical trials. Available at: https://www. mckinsey.com/industries/life-sciences/our-insights/no-place-like-home-stepping-up-the-decentralization-of-clinical-trials. Accessed on: November 2021Search in Google Scholar
Zarka A et al. Virtual clinical trials: Perspectives in Dermatology. Dermatology 2020; 236; 375-382. DOI:10.1159/000506418Search in Google Scholar
Apostolaros M et al. Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative. Ther Innov Regul Sci . 2020 Jul;54(4):779-787. doi: 10.1007/s43441-019-00006-4.Search in Google Scholar
Van Norman GA. Decentralized Clinical Trials.The Future of Medical Product Development? JACC Basic Transl Sci. 2021 Apr 27;6(4):384-387. doi: 10.1016/j.jacbts.2021.01.011Search in Google Scholar
Krishna S. Gunturu et al. Clinical Trials in the Era of Digital Engagement: A SWOG Call to Action. JCO Clin Cancer Inform. 2020 Mar;4:254-258. doi: 10.1200/CCI.19.00128Search in Google Scholar
Yu Zhuang et al. Applying Blockchain Technology for Health Information Exchange and Persistent Monitoring for Clinical Trials. AMIA Annu Symp Proc. 2018 Dec 5;2018:1167-1175.Search in Google Scholar
De Brouwer W et al. Empowering clinical research in a decentralized world. NPJ Digit Med. 2021 Jul 1;4(1):102. doi: 10.1038/s41746-021-00473-w.Search in Google Scholar
Sundquist S, Batist G, Brodeur-Robb K, et al. CRAFT-A Proposed Framework for Decentralized Clinical Trials Participation in Canada. Curr Oncol. 2021 Sep 30;28(5):3857-3865. doi: 10.3390/curroncol28050329.Search in Google Scholar
Tan AC et al. Adapting to a Pandemic - Conducting Oncology Trials during the SARS-CoV-2 Pandemic 2020. Clin Cancer Res. 2020 Jul 1;26(13):3100-3103. doi: 10.1158/1078-0432. CCR-20-1364.Search in Google Scholar
Haak D et al. DICOM for Clinical Research: PACS-Integrated Electronic Data Capture in Multi-Center Trials. J Digit Imaging. 2015 Oct;28(5):558-66. doi: 10.1007/s10278-015-9802-8.Search in Google Scholar
Lehrach H. Virtual Clinical Trials, an Essential Step in Increasing the Effectiveness of the Drug Development Process. Public Health Genomics. 2015;18(6):366-71. doi: 10.1159/000441553.Search in Google Scholar
Sommer C, Zuccolin D, Arnera V, Schmitz N, Adolfsson P, Colombo N, Gilg R, McDowell B. Building clinical trials around patients: Evaluation and comparison of decentralized and conventional site models in patients with low back pain. Contemp Clin Trials Commun. 2018 Jun 28;11:120-126. doi: 10.1016/j.conctc.2018.06.008.Search in Google Scholar
Dorsey ER et al. The triple aim of clinical research. Clin Trials. 2021;18(4):511-513. doi: 10.1177/17407745211001522Search in Google Scholar
Spertus JA et al. Novel Trial Design: CHIEF-HF. Circ Heart Fail. 2021;14(3):e007767. doi: 10.1161/CIRCHEARTFAILURE.120.007767Search in Google Scholar
Lee EQ et al. Report of National Brain Tumor Society roundtable workshop on innovating brain tumor clinical trials: building on lessons learned from COVID-19 experience. Neuro Oncol. 2021 Aug 2;23(8):1252-1260. doi: 10.1093/neuonc/noab082Search in Google Scholar
Gouda P et al. Feasibility of Incorporating Voice Technology and Virtual Assistants in Cardiovascular Care and Clinical Trials. Curr Cardiovasc Risk Rep. 2021;15(8):13. doi: 10.1007/ s12170-021-00673-9Search in Google Scholar
Persky S. A Virtual Home for the Virtual Clinical Trial. J Med Internet Res. 2020 Jan 3;22(1):e15582. doi: 10.2196/15582Search in Google Scholar
Hashem H et al. Obstacles and Considerations Related to Clinical Trial Research During the COVID-19 Pandemic. Front Med (Lausanne). 2020 23;7:598038. doi: 10.3389/ fmed.2020.598038Search in Google Scholar
McGoohan K et al. A Preliminary Investigation of the Views of People With Parkinson’s (With and Without Psychosis) and Caregivers on Participating in Clinical Trials During the Covid-19 Pandemic: An Online Survey. Front Psychiatry. 2020 Dec 23;11:602480. doi: 10.3389/fpsyt.2020.602480.Search in Google Scholar
Ali Z et al. High adherence and low dropout rate in a virtual clinical study of atopic dermatitis through weekly reward-based personalized genetic lifestyle reports. PLoS One. 2020 Jul 2;15(7):e0235500. doi: 10.1371/journal.pone.0235500.Search in Google Scholar
Yaakov RA et al. Enhancing Patient Centricity and Advancing Innovation in Clinical Research with Virtual Randomized Clinical Trials (vRCTs). Diagnostics (Basel). 2021 Jan 21;11(2):151. doi: 10.3390/diagnostics11020151Search in Google Scholar
Wang H et al. Conducting a Virtual Clinical Trial in HER2-Negative Breast Cancer Using a Quantitative Systems Pharmacology Model With an Epigenetic Modulator and Immune Checkpoint Inhibitors. Front Bioeng Biotechnol. 2020 Feb 25;8:141. doi: 10.3389/fbioe.2020.00141.Search in Google Scholar
Kadakia KT et al. Virtual Clinical Trials in Oncology-Overview, Challenges, Policy Considerations, and Future Directions. JCO Clin Cancer Inform. 2021 Apr;5:421-425. doi: 10.1200/ CCI.20.00169.Search in Google Scholar
Yan Zhuang et al. Development of A Blockchain Framework for Virtual Clinical Trials. AMIA Annu Symp Proc. 2021 Jan 25;2020:1412-1420.Search in Google Scholar
Ieronimakis KM et al. Leveraging Tele-Critical Care Capabilities for Clinical Trial Consent. Crit Care Explor. 2020;2(7):e0167. doi: 10.1097/CCE.0000000000000167Search in Google Scholar
Schneider RB et al. Design of a virtual longitudinal observational study in Parkinson’s disease (AT-HOME PD). Ann Clin Transl Neurol. 2021 Feb;8(2):308-320. doi: 10.1002/ acn3.51236.Search in Google Scholar
Marra C et al. Use of connected digital products in clinical research following the COVID-19 pandemic: a comprehensive analysis of clinical trials. BMJ Open. 2021 Jun 22;11(6):e047341. doi: 10.1136/bmjopen-2020-047341.Search in Google Scholar
Getz K et al. Assessing the Scope and Predictors of Intentional Dose Non-adherence in Clinical Trials. Ther Innov Regul Sci. 2020 Nov;54(6):1330-1338. doi: 10.1007/s43441-020-00155-x.Search in Google Scholar
Vinay Singh et al. COVID-19 and Clinical Trials: Current Challenges and Future Directions. Rev Recent Clin Trials. 2021;16(3):258-261. doi: 10.2174/1574887116666210122160705.Search in Google Scholar
Coert RMH, Timmis JK, Boorsma A, Pasman WJ. Stakeholder Perspectives on Barriers and Facilitators for the Adoption of Virtual Clinical Trials: Qualitative Study. J Med Internet Res. 2021 Jul 6;23(7):e26813. doi: 10.2196/2681Search in Google Scholar
Samei E et al. Virtual Clinical Trials: Why and What (Special Section Guest Editorial). J Med Imaging (Bellingham). 2020 Jul;7(4):042801. doi: 10.1117/1.JMI.7.4.042801.Search in Google Scholar
Chiamulera C, Mantovani E, Tamburin S. Remote clinical trials: A timely opportunity for a virtual reality approach and its potential application in neurology. Br J Clin Pharmacol. 2021 Oct;87(10):3639-3642. doi: 10.1111/bcp.14922Search in Google Scholar
Petrini C, Mannelli C, Riva L, et al. Decentralized clinical trials (DCTs): A few ethical considerations. Front Public Health. 2022 Dec 15;10:1081150. doi: 10.3389/fpubh.2022.1081150Search in Google Scholar
Goodson N, Wicks P, Morgan J, Hashem L, Callinan S, Reites J. Opportunities and counterintuitive challenges for decentralized clinical trials to broaden participant inclusion. NPJ Digit Med. 2022 May 5;5(1):58. doi: 10.1038/s41746-022-00603-ySearch in Google Scholar
Coyle J, Rogers A, Copland R, et al. Trials@Home Consortium. A secondary qualitative analysis of stakeholder views about participant recruitment, retention, and adherence in decentralised clinical trials (DCTs). Trials. 2022 Jul 30;23(1):614. doi: 10.1186/s13063-022-06521-4.Search in Google Scholar
Adams DV, Long S, Fleury ME. Association of Remote Technology Use and Other Decentralization Tools With Patient Likelihood to Enroll in Cancer Clinical Trials. JAMA Netw Open. 2022 Jul 1;5(7):e2220053. doi: 10.1001/jamanetworkopen.2022.20053Search in Google Scholar
Moore J, Goodson N, Wicks P, Reites J. What role can decentralized trial designs play to improve rare disease studies? Orphanet J Rare Dis. 2022 20;17(1):240. doi: 10.1186/ s13023-022-02388-5Search in Google Scholar
Rogers A, De Paoli G, Subbarayan S, et al. Trials@Home Consortium. A systematic review of methods used to conduct decentralised clinical trials. Br J Clin Pharmacol. 2022;88(6):2843-2862. doi: 10.1111/bcp.15205.Search in Google Scholar
De Las Heras B, Daehnke A, Saini KS, et al. Role of decentralized clinical trials in cancer drug development: Results from a survey of oncologists and patients. Digit Health. 2022 May 25;8:20552076221099997. doi: 10.1177/20552076221099997.Search in Google Scholar
DiMasi JA, Smith Z, Oakley-Girvan I, et al. Assessing the Financial Value of Decentralized Clinical Trials. Ther Innov Regul Sci. 2023 Mar;57(2):209-219. doi: 10.1007/s43441-022-00454-5Search in Google Scholar
De Jong A, van Rijssel T, Zuidgeest M et al. Opportunities and challenges for decentralized clinical trials: European Regulators Perspective. Clinical Pharmacology & Therapeutics 2022; 112 (2):344-352. Doi: https://doi.org/10.1002/cpt.2628Search in Google Scholar
