Abstract:

This study aims to explore the perceptions of clinical researchers in India regarding the use and importance of decentralized clinical trial (DCT) elements and to identify associated organizational and therapeutic area-specific trends. A cross-sectional questionnaire-based survey was conducted among 112 clinical research professionals across various organizational types, including sponsor companies, contract research organizations (CROs), and academic institutions. Data was analyzed to assess the extent of DCT elements importance for its adoption and implementation in the organization based on the drug development pipeline. A statistical test was used to examine the association between organizational type and DCT elements adoption levels. The findings revealed a growing inclination toward hybrid trial models, with 78.6% of respondents indicating partial decentralization within their organizations. Only 11.6% of respondents reported a fully decentralized trial, highlighting regulatory, infrastructural, and operational constraints. A significant association was found between organizational type and DCT adoption (p = 0.045), suggesting that service providers and sponsor companies differ in their strategic approaches. Adoption patterns varied across therapeutic areas, with hybrid models dominating in complex conditions such as oncology and cardiovascular diseases and fully decentralized trials more common in dermatology and infectious diseases. Key enabling technologies included electronic signatures, remote source data verification, and AI-driven analytics, while infrastructure-heavy components like direct-to-patient delivery were less prioritized. DCT element adoption in India remains moderate and is primarily characterized by hybrid models. Service providers are emerging as key enablers of digital transformation, but regulatory ambiguity, gaps in digital infrastructure, and limited organizational readiness hinder broader implementation. Tailored policies, capacity-building initiatives, and therapeutic-specific strategies are essential for accelerating DCT integration.

References:

[1]. U.S. Food & Drug Administration (FDA) guidance document on conducting clinical trials with decentralized elements., 2024 Sep. https://www.fda.gov/media/167696/download

[2]. Banks, M., 2021, In the wake of COVID-19, decentralized clinical trials move to center stage. PNAS, November 17, 118 (47) e2119097118, https://doi.org/10.1073/pnas.2119097118

[3]. Stern, A. D., Trusheim, M., 2024, Transformation of the clinical trial enterprise: lessons learned from the COVID-19 pandemic: final report. Decentralized clinical trials and digital health technologies. Feb 9, https://www.ncbi.nlm.nih.gov/books/NBK609002/

[4]. Alemayehu, D., Hemmings, R., Natarajan, K., et al., 2022, Perspectives on Virtual (Remote) Clinical Trials as the "New Normal" to Accelerate Drug Development. Clinical Pharmacology Therapeutics, Feb, 111(2):373-381. doi: 10.1002/cpt.2248. Epub 2021 Apr 19. PMID: 33792920.

[5]. Hanley, D. F., Jr. Bernard, G. R., et al., 2023, Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned. Journal of Clinical Translational Science Jul 25. 7(1): e170. doi: 10.1017/cts.2023.597. PMID: 37654775; PMCID: PMC10465321.

[6]. Chodankar, D., Raval, T., K., Jeyaraj, J., 2024, The role of remote data capture, wearables, and digital biomarkers in decentralized clinical trials. Perspectives in Clinical Research 15(1): p 38-41, Jan–Mar| DOI: 10.4103/picr.picr_219_22

[7]. Sato, T., Mizumoto, S., Ota, M., et al., 2023, Implementation status and consideration for the globalisation of decentralised clinical trials: A cross-sectional analysis of clinical trial databases. BMJ Open, 13(10), e074334. https://doi.org/10.1136/bmjopen-2023-074334.

[8]. GlobalData, 2022, Clinical trials – The movement towards decentralized clinical trials. October 10 Date of access: 25/05/2025. https://www.globaldata.com/store/report/decentralized-clinical-trials-insight-analysis/

[9]. Wang, M., Huang, K., et al., 2025. Health workers’ adoption of digital health technology in low- and middle-income countries: a systematic review and meta-analysis. Bulletin World Health Organization; 103:126–135F| doi: http://dx.doi.org/10.2471/BLT.24.292157

[10]. Inampudi, S., Rajkumar, E., Gopi, A., et al., 2024, Barriers to implementation of digital transformation in the Indian health sector: a systematic review. Humanities and Social Sciences Communications 11, 632 https://doi.org/10.1057/s41599-024-03081-7

[11]. Gupta, P., Rai, C., et al., 2023, A Comprehensive Roadmap for MedTech Innovations Uptake into the Public Healthcare System in India. Frontiers in Digital Health. DOI: 10.3389/fdgth.2023.1268010

[12]. Valachis, A., Lindman, H., 2024, Lessons learned from an unsuccessful decentralized clinical trial in Oncology. npj Digit. Med. 7, 211, https://doi.org/10.1038/s41746-024-01214-5

[13]. Setia, M. S., 2016, Methodology series module 3: Cross-sectional studies. Indian Journal of Dermatology, 61(3), 261–264. https://doi.org/10.4103/0019-5154.182410

[14]. Leyens, L., Simkins, T., Horst, N. K., 2022, The COVID-19 pandemic as a catalyst for innovation: a regulatory framework to assess fit-for-purpose innovative approaches in clinical research. Trials 23, 833, https://doi.org/10.1186/s13063-022-06707-w

[15]. Lamberti, M. J., Smith Z., Dirks, A., et al., 2022, The Impact of Decentralized and Hybrid Trials on Sponsor and CRO Collaborations. Applied clinical trials, July 27. Date of access: 27/05/2025, https://www.appliedclinicaltrialsonline.com/view/the-impact-of-decentralized-and-hybrid-trials-on-sponsor-and-cro-collaborations

[16]. Sehrawat, O., Noseworthy, P., A., Siontis, K., C., et al., 2023, Data-Driven and Technology-Enabled Trial Innovations Toward Decentralization of Clinical Trials: Opportunities and Considerations. Mayo Clinic Proceedings, Volume 98, Issue 9, September, Pages 1404-1421, https://doi.org/10.1016/j.mayocp.2023.02.003

[17]. Apostolaros, M., Babaian, D., Corneli, A. et al., 2020, Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: recommendations from the clinical trials transformation initiative. Ther Innov Regul Sci 54, 779–787, https://doi.org/10.1007/s43441-019-00006-4

[18]. Izmailova, E., S., Ellis, R., Benko, C., 2020, Remote Monitoring in Clinical Trials During the COVID-19 Pandemic. Clin Transl Sci. Sep;13(5):838-841. doi: 10.1111/cts.12834. Epub 2020 Jul 8. PMID: 32526077; PMCID: PMC7307062.

[19]. Moogi, A., Kalyandurgamath, K., 2022, A Review of significance of Decentralized Clinical Trials in India and impact of Data Analytics in Clinical Data. Dec 11, YMER || ISSN: 0044-0477, https://ymerdigital.com/

[20]. DiMasi, J., A., Smith, Z., Oakley-Girvan, I., et al., 2023, Assessing the Financial Value of Decentralized Clinical Trials. Ther Innov Regul Sci 57, 209–219, https://doi.org/10.1007/s43441-022-00454-5

[21]. Izmailova, E., S., Wagner, J., A., Ammour, N., et al., 2020, Remote Digital Monitoring for Medical Product Development. Clin Transl Sci., 23 July, https://doi.org/10.1111/cts.12851

[22]. Sabu, S., T., Venkatraman, S., Cherian, J., et al., 2024, A review of clinical trials registered in India from 2008 to 2022 to describe the first-in-human trials. Perspectives in Clinical Research 15(1): p 18-23, DOI: 10.4103/picr.picr_124_23

[23]. Pelter, M., N., Quer, G., Pandit, J., 2023, Remote Monitoring in Cardiovascular Diseases. Curr Cardiovasc Risk Rep 17, 177–184, https://doi.org/10.1007/s12170-023-00726-1

[24]. Mayfield, J., J., Chatterjee, N., A., Noseworthy, P., A., et al., 2021, Implementation of a fully remote randomized clinical trial with cardiac monitoring. Commun Med 1, 62. https://doi.org/10.1038/s43856-021-00052-w

[25]. Portnoy, J., M., Pandya, A., Waller, M., et al., 2020, Telemedicine and emerging technologies for health care in allergy/immunology. Journal of Allergy and Clinical Immunology, Volume 145, Issue 2, February, Pages 445-454, https://doi.org/10.1016/j.jaci.2019.12.903

[26]. Bernard, L., Valsecchi, V., Mura, T., et al., 2022, Management of patients with rheumatoid arthritis by telemedicine: connected monitoring. A randomized controlled trial. Joint Bone Spine, Volume 89, Issue 5, October, 105368, https://doi.org/10.1016/j.jbspin.2022.105368

[27]. Samanta, J., Mishra, D., 2022, Future of Digital Health and Precision Medicine in Rheumatology Practice in India. Indian Journal of Rheumatology 17(Suppl 3):p S426-S430, December. | DOI: 10.4103/injr.injr_146_22

[28]. Shah, A., C., O’Dwyer, L., C., Badawy, S., M., 2021, Telemedicine in Malignant and Nonmalignant Hematology: Systematic Review of Pediatric and Adult Studies. JMIR Mhealth Uhealth, 9(7):e29619, doi: 10.2196/29619|PMID: 34255706|PMCID: 8299344

[29]. Ali, Z., Zibert, J., R., Thomsen, S., F., 2020, Virtual Clinical Trials: Perspectives in Dermatology. Dermatology 236 (4): 375–382, Volume 236, Issue 4, https://doi.org/10.1159/000506418

[30]. Vashisht, K., R., Sahu, P., Mandula, P., P., et al., 2024, Bridging gaps in pediatric dermatology via telemedicine: An analytical cross-sectional study on 961 children in resource-limited areas of North India using the e-Sanjeevani 2.0 platform. Indian J Dermatol Venereol Leprol. doi: 10.25259/IJDVL_1223_2024

[31]. Coombes, C., E., Gregory, M., E., 2019, The Current and Future Use of Telemedicine in Infectious Diseases Practice. Curr Infect Dis Rep 21, 41, https://doi.org/10.1007/s11908-019-0697-2

[32]. Anjana R., M., Pradeepa, R., Deepa, M., 2020, Acceptability and Utilization of Newer Technologies and Effects on Glycemic Control in Type 2 Diabetes: Lessons Learned from Lockdown. Diabetes Technology & Therapeutics, Vol. 22, No. 7, https://doi.org/10.1089/dia.2020.0240

[33]. Fu, S., Gerber, D., E., Beg, M., S., 2022, Decentralized Clinical Trials in Oncology: Are We Ready for a Virtual-First Paradigm? J Clin Oncol. 2023 Jan 10;41(2):181-185. doi: 10.1200/JCO.22.00358. Epub Aug 22. PMID: 35994691; PMCID: PMC9839231.

[34]. Adams, D., V., Long, S., Fleury, M., E., 2022, Association of Remote Technology Use and Other Decentralization Tools with Patient Likelihood to Enroll in Cancer Clinical Trials. JAMA Netw., 5(7): e2220053. doi:10.1001/jamanetworkopen.2022.20053

[35]. Bhalsod, D., Taksande, K., Paul, A., et al., 2025, Bridging the gap between ICU and home-based care: A review of wearable technologies and remote monitoring in critical care. Multidisciplinary Reviews, 8(8), 2025256. https://doi.org/10.31893/multirev.2025256

[36]. Dhengale, M., Nagrik, S., Bathe, H., et al., 2025, Challenges and Innovations in Conducting Clinical Trials in Rare and Orphan Diseases. Int. J. Sci. R. Tech., 2025, 2 (5), 427-441. https://doi.org/10.5281/zenodo.15459246

[37]. Hanley, D., F., Bernard, G., R., Wilkins, C., H., et al., 2023, Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned. Journal of Clinical and Translational Science. 2023;7(1): e170. doi:10.1017/cts.2023.597

[38]. Bhatt, A., 2014, Clinical trials in India: Way forward. Perspectives in Clinical Research 5(2):p 53-54, Apr–June | DOI: 10.4103/2229-3485.128017

[39]. Cummins, M., R., Burr, J., Young, L., et al., 2023, Decentralized research technology use in multicenter clinical research studies based at U.S. academic research centers. Journal of Clinical and Translational Science.,7(1): e250. doi:10.1017/cts.2023.678

[40]. Krittanawong, C., Aydar, M., Virk, H., U., 2022, Artificial Intelligence-Powered Blockchains for Cardiovascular Medicine. Canadian Journal of Cardiology, Volume 38, Issue 2, February, Pages 185-195, https://doi.org/10.1016/j.cjca.2021.11.011