Realignment of clinical research after the COVID-19 era

The COVID-19 pandemic has massively disrupted clinical research worldwide. 1 Gaudino M Arvind V Hameed I et al. Effects of the COVID-19 pandemic on active non-COVID clinical trials. J Am Coll Cardiol. 2020; 76: 1605-1606 Crossref PubMed Scopus (16) Google Scholar Guidelines are now available for the conduct of research in the context of a pandemic, 2 U.S. Food and Drug AdministrationFDA guidance on conduct of clinical trials of medical products during COVID-19 public health emergency. https://www.hhs.gov/ohrp/sites/default/files/fda-covid-guidance-2apr2020.pdfDate accessed: January 15, 2024 Google Scholar , 3 European Medicines AgencyGuidance on the management of clinical trials during the COVID-19 (Coronavirus) pandemic. Version 3. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdfDate: Feb 10, 2022 Date accessed: January 15, 2024 Google Scholar and most ongoing trials include modifications such as providing medications for an extended period or delivering by mail, shifting face-to-face consultations to remote monitoring, completing questionnaires over the telephone or using email, postal service, or online questionnaires, reducing the number of visits, conducting out-of-hospital visits, and establishing satellite sites. 1 Gaudino M Arvind V Hameed I et al. Effects of the COVID-19 pandemic on active non-COVID clinical trials. J Am Coll Cardiol. 2020; 76: 1605-1606 Crossref PubMed Scopus (16) Google Scholar , 4 Upadhaya S Yu JX Oliva C Hooton M Hodge J Hubbard-Lucey VM Impact of COVID-19 on oncology clinical trials. Nat Rev Drug Discov. 2020; 19: 376-377 Crossref PubMed Scopus (94) Google Scholar , 5 Suman A van Es J Gardarsdottir H et al. 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. 2022; 23: 856 Crossref PubMed Scopus (3) Google Scholar Hence, COVID-19 partially or fully transformed clinical research into a virtual or remote model, also called tele-trials. The question is whether the changes enforced by COVID-19 are transient adjustments or realignment of the global clinical research framework. In this Comment, we discuss some of the opportunities and threats of these clinical research transfigurations from the context of two respiratory tele-trials designed and executed during the COVID-19 pandemic.