Viewpoint: Decentralized Clinical Trials Have Arrived and Staying for Good
Mary Suzette R. Cody
Oct 2022 DOI 10.35460/2546-1621.2022-0051 Access
The Covid-19 pandemic challenged every healthcare system, and the disruption of clinical trials was not the least of it. Many clinical trials halted or did not activate as sponsors and investigators grappled with the risk of infection if patients involved in clinical trials visited trial sites. The clinical studies that managed to continue and complete were those that immediately adopted decentralized clinical trials (DCT) technologies such as eSource. Patients were engaged from the comfort and convenience of their homes during the clinical trials with the use of DCT technologies. The flexibility in recruitment, engagement, and monitoring of clinical trial participants are among the reasons why DCTs are here to stay.
- Unger JM, Xiao H. The COVID-19 pandemic and new clinical trial activations. Trials [Internet]. 2021 Apr 8;22(1). Available from: http://dx.doi.org/10.1186/s13063-021-05219-3
- Ledford H. The COVID pandemic’s lingering impact on clinical trials. Nature [Internet]. 2021 Jun 28;595(7867):341–2. Available from: http://dx.doi.org/10.1038/d41586-021-01569-9
- Center for Drug Evaluation, Research. Electronic Source Data in Clinical Investigations [Internet]. U.S. Food and Drug Administration. FDA; [cited 2022 Oct 28]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-source-data-clinical-investigations
- Eisenstein EL, Garza MY, Rocca M, Gordon GS, Zozus M. eSource-Enabled vs. Traditional Clinical Trial Data Collection Methods: A Site-Level Economic Analysis. Stud Health Technol Inform. 2020 Jun 16;270:961-965. doi: 10.3233/SHTI200304. PMID: 32570524.
- Missiuro PV. Spurred by the Pandemic, eSource is Changing Oncology Trials [Internet]. Onco’Zine - International Oncology Network - Cancer & Hematology News. Sunvalley Communication | In Press Media Group; 2022 [cited 2022 Nov 1]. Available from: https://www.oncozine.com/spurred-by-the-pandemic-esource-is-changing-oncology-trials/
- Guidance Document. FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Guidance for Industry, Investigators, and Institutional Review Boards, August 2021.
- Decentralized clinical trials: Perspectives for clinical research professionals [Internet]. ACRP. Association of Clinical Research Professionals; 2022 [cited 2022 Oct 28]. Available from: https://acrpnet.org/decentralized-clinical-trials-perspectives-for-clinical-research-professionals/
- Bestsennyy O, Gilbert G, Harris A, Rost J. Telehealth: A quarter-trillion-dollar post-COVID-19 reality? [Internet]. Mckinsey.com. McKinsey & Company; 2021 [cited 2022 Oct 28]. Available from: https://www.mckinsey.com/industries/healthcare-systems-and%20services/our-insights/telehealth-a-quarter-trillion-dollar-post-covid-19-reality
- No place like home? Stepping up the decentralization of clinical trials [Internet]. Mckinsey.com. McKinsey & Company; 2021 [cited 2022 Oct 28]. Available from: https://www.mckinsey.com/industries/life-sciences/our-insights/no-place-like-home-stepping-up-the-decentralization-of-clinical-trials
Articles related to the one you are viewing
There are currently no results to show, please try again later
Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License, which permits use, share — copy and redistribute the material in any medium or format, adapt — remix, transform, and build upon the material, as long as you give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use. You may not use the material for commercial purposes. If you remix, transform, or build upon the material, you must distribute your contributions under the same license as the original. You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit https://creativecommons.org/licenses/by-nc-sa/4.0/.