Decentralized Clinical Trials – Systematic Review of Methods, Awareness, and Inclusiveness in Clinical Research

Download Article

DOI: 10.21522/TIJAR.2014.10.04.Art010

Authors : Srividhya Narasimhan, Vishnubalaji Radhakrishnan

Abstract:

"Decentralised" trials (also known as hybrid, remote, or virtual trials) are the trials that covers a wide range of services and solutions that can be mixed and matched based on the conditions, preferences, and needs of patients, clinical locations, and sponsors. The research on Decentralised Clinical Trials is carried out through a series of interviews to better understand the perspectives of stakeholders involved in the DCT and how the industry accelerates and fast tracks the digital transformation to strive for paperless and patient-centric outcomes. In the present study, the data Collection were performed through extensive survey with the detailed questionnaire on the awareness of DCT, applied DCT tools in their research project, benefits and challenges overcome during the trial and DCT applications during the list of study phases, timeframe for using the rapid adoption of DCT.  The current study's findings give significant evidence that decentralised clinical trials offer a promising new strategy to clinical research, allowing for speedier, more efficient, and more flexible study designs. DCTs are set to become an increasingly essential element of the clinical research landscape as digital technologies evolve and improve, providing new opportunities to enhance healthcare outcomes for all.The use of DCT in clinical trials has the potential to overcome a number of important drug development difficulties. DCT solutions may improve easier data collection, patient adherence and overall retention rates in addition to improving patient access and convenience.
Keywords: Anticipated challenges, Clinical trials, COVID pandemic; Decentralized trials, Feasibility; Health care.

References:

[1] Akhondzadeh S. (2016). The Importance of Clinical Trials in Drug Development. Avicenna journal of medical biotechnology, 8(4), 151.  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5124250/.

[2] Novitzke J. M. (2008). The significance of clinical trials. Journal of vascular and interventional neurology, 1(1), 31. https://www.ncbi.nlm.nih.gov/pmc/ articles/ PMC3317309/.

[3] 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., Marlin, B. M., Mandl, K. D., Klasnja, P., Spring, B., Iturriaga, E., Campo, R., Desvigne-Nickens, P., Rosenberg, Y., Steinhubl, S. R., & Califf, R. M. (2020). Digitizing clinical trial. NPJ digital medicine, 3,101. https://pubmed.ncbi.nlm.nih.gov/ 32821856/.

[4] Clinical Trials Transformation Initiative CTTI recommendations: decentralized clinical trials. September 2018. https://www.ctti-clinicaltrials.org/sites/www.ctti clinicaltrials.org/files/dct_recommendations_final.pdf.

[5] Andrew Borrows (2020): Decentralized and Hybrid Clinical Trials Report 2020 retreived from: https://informaconnect.com/decentralized-hybrid-clinical-trials-report-2020a/.

[6] Dustin Phan (2020): The Impact Of COVID-19 On Clinical Trials retrieved from https://invivo.pharmaintelligence.informa.com/IV124523/The-Impact-Of-COVID-19-On-Clinical-Trials.

[7] Moogi, A., & Kalyandurgamath, K. (2022). A Review of significance of Decentralized  Clinical Trials in India and impact of Data Analytics in Clinical Data Introduction. 21. https://ymerdigital.com/uploads/YMER211250.pdf.

[8] Rogers, A., De Paoli, G., Subbarayan, S., Copland, R., Harwood, K., Coyle, J., Mitchell, L., MacDonald, T. M., Mackenzie, I. S., & Trials@Home Consortium (2022). A systematic review of methods used tos conduct decentralised clinical trials. British journal of clinical pharmacology, 88(6), 2843–2862. https://www.ncbi. nlm. nih.gov /pmc /articles/PMC9306873.

[9] Suvarna V. (2012). Investigator initiated trials (IITs). Perspectives in clinical research, 3(4), 119–121. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3530977.

[10] Carson, P., Ziesche, S., Johnson, G., & Cohn, J. N. (1999). Racial differences in response to therapy for heart failure: analysis of the vasodilator-heart failure trials. Vasodilator-Heart Failure Trial Study Group. Journal of cardiac failure, 5(3), 178–187. https://pubmed.ncbi.nlm.nih.gov/10496190.

[11] Conforti, F., Pala, L., Bagnardi, V., De Pas, T., Martinetti, M., Viale, G., Gelber, R. D., & Goldhirsch, A. (2018). Cancer immunotherapy efficacy and patients' sex : a systematic review and meta-analysis. The Lancet. Oncology, 19(6), 737–746. https://pubmed.ncbi.nlm.nih.gov/29778737.

[12] Van Rijssel, T. I., de Jong, A. J., Santa-Ana-Tellez, Y., Boeckhout, M., Zuidgeest, M. G. P., van Thiel, G. J. M. W., & Trials@Home Consortium (2022). Ethics review of decentralized clinical trials (DCTs): Results of a mock ethics review. Drug discovery today, 27(10), 103326. https://pubmed.ncbi.nlm.nih.gov/35870693.

[13] Gussoni G (2022). Implementing Decentralized Clinical Trials in Italy: Why and How? TendenzeNuove, Special Issue 2. https://www.eucrof.eu/images/ Implementing _Decentralised_ Clinical_Trials_in_Italy-Why_and_How_June_2022_ co-author_ Dr_Stefano_Marini.pdf.

[14] Gabbrielli F, Zibellini M, Triola R, Bocchino M (2022). Decentralized Clinical Trial e telemedicina: nuovo approccioallasperimentazioneclinica per facilitare il paziente e velocizzare la ricerca. Rapporti ISTISAN , 22(4).135. https://journals.aboutscience.eu/ index.php/aboutopen/article/view/2546.

[15] Josan, K.; Touros, A.; Petlura, C.; Parameswaran, V.; Grewal, U.; Senior, M.; Viethen, T.; Mundl, H.; Seninger, C.; Luithle, J.; Mahaffey, K.; Turakhia, M.; Dash, R. (2021). Validation of a pandemic-proof, decentralized cardiovascular trial: scalable design produces rapid recruitment, high  

engagement and protocol adherence in DeTAP (Decentralized Trial in Afib Patients). European Heart Journal; 42(SUPPL 1):3177, 2021. EMBASE. https://pesquisa.bvsalud.org/global-literature-on-novel-coronavirus-2019-ncov/resource/pt/covidwho-1554235.

[16] Khozin, S., & Coravos, A. (2019). Decentralized Trials in the Age of Real-World Evidence and Inclusivity in Clinical Investigations. Clinical pharmacology and therapeutics, 106(1), 25–27. https://pubmed.ncbi.nlm.nih.gov/31013350.

[17] FDA (2023) Takes Additional Steps to Advance Decentralized Clinical Trials.

[18] Van Norman G. A. (2021). Decentralized Clinical Trials: The Future of Medical Product Development?.JACC. Basic to translational science, 6(4), 384–387. https://pubmed.ncbi.nlm.nih.gov/33997523.

[19] de Jong, A. J., van Rijssel, T. I., Zuidgeest, M. G. P., van Thiel, G. J. M. W., Askin, S., Fons-Martínez, J., De Smedt, T., de Boer, A., Santa-Ana-Tellez, Y., Gardarsdottir, H., &Trials@Home Consortium (2022). Opportunities and Challenges for Decentralized Clinical Trials: European Regulators' Perspective. Clinical pharmacology and therapeutics, 112(2),344–352. https://pubmed.ncbi.nlm.nih.gov /35488483/.

[20] Suman, A., van Es, J., Gardarsdottir, H., Grobbee, D. E., Hawkins, K., Heath, M. A., Mackenzie, I. S., van Thiel, G., Zuidgeest, M. G. P., & Trials@Home Consortium (2022). A cross-sectional survey on the early impact of COVID-19 on the uptake of decentralised trial methods in the conduct of clinical trials. Trials, 23(1), 856. https://pubmed.ncbi.nlm.nih.gov/36203202/.

[21] Nolan, I. M.; Tsolovska, A (2021.). Decentralised clinical trial adoption: lessons learnt from the pandemic. Regulatory Rapporteur. 18(9):26-30, https://www.ppd.com/wp-content/uploads/2021/08/Regulatory-Rapporteur-2021-09-Regulatory-Intelligence.pdf.