Remote Research and Clinical Trial Integrity During and After the Coronavirus Pandemic

Remote Research and Clinical Trial Integrity During and After the Coronavirus PandemicApproximately 1 year ago, in March 2020, clinical trials were suddenly and severely disrupted by the COVID-19 pandemic.Pandemic-related restrictions that limited or prevented in-person visits resulted in unprecedented obstacles to clinical trial enrollment, data collection, and intervention delivery for many clinical trials. 1 As of April 21, 2021, ClinicalTrials.govlisted 1773 suspended clinical trials, with many trials identifying the COVID-19 pandemic as the primary reason for suspension.Ongoing trials that were not suspended are likely to be experiencing challenges with enrollment and fidelity to aspects of study protocols that require in-person contact, including interventions and outcome assessment.Many clinical trial investigators replaced in-person interactions with alternative approaches conducted remotely. 2A survey of 245 clinical trial investigators reported that the proportion of participant interactions conducted remotely increased from 9% in January 2020 to 57% in May 2020. 2 Remote interactions with participants implemented in response to the pandemic included mailings or drop-off of devices, such as physical activity monitors or pulse oximeters for outcome measurements, and mail delivery or drop-off of pills or devices for trial interventions. 3,44][5] These remote activities facilitated clinical trial progress during the pandemic.Embedded trials build data collection for a clinical trial into essential clinical care and represent another alternative to in-person clinical trial interactions.An example is the ongoing Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults (PREVENTABLE) trial (NCT04262206), in which 20 000 participants 75 years or older are randomized to atorvastatin 40 mg daily or placebo and followed up with the electronic health record for outcomes of disability-free survival and cardiovascular events.Medications are mailed to participants' homes.Outcomes that are not part of routine clinical care, including detailed cognitive assessments and physical performance testing, are collected at participants' homes by trained research staff.A visit to a research laboratory is required to collect blood for a biorepository of red blood cells and DNA.An example of a fully remote trial was a randomized, double-blind, clinical trial conducted in St Louis, Missouri, that evaluated whether fluvoxamine, compared with placebo, improved outcomes in 152 outpatients newly diagnosed with COVID-19. 4Eligibility screening was conducted by email and telephone and COVID diagnosis was confirmed using electronic health record