With long-lasting effects on medical science, reports Aaron van Dorn, the COVID-19 pandemic has created massive disruptions to clinical trial research across the world. As in other aspects of life, the virus has severely affected the ability to conduct trials in safe and effective ways. This is especially true when considering that trials often deal with vulnerable populations who are most at risk from exposure to COVID-19.
Reorientation Taking Place in the Clinical Trial Space
Thousands of trials have been suspended or stopped because of the difficulties in continuing under lockdown conditions, even as those restrictions have begun to ease in parts of the world. At the same time, the pandemic has seen an unprecedented reorientation in clinical trials research towards COVID-19. Both of those aspects—the disruption and the fast, effective readjustment to address a new challenge—ensure that the effects of the COVID-19 pandemic will be felt in clinical trials research long after the initial effects have faded.
Trials that were stopped, in many cases, were stopped from enrolling new patients. Patients who were already enrolled mostly continued to receive treatment as institutions and researchers worked to make changes to how care was provisioned to deal with the reality of COVID-19. To that end, many trials have shifted from the distribution of drugs at the trial site to direct-to-patient courier services, whereby trial drugs are distributed and administered to patients in their homes, eliminating the need for at-risk patients to visit trial sites. Many in-person visits for checkups and other aspects of trials were shifted to teleconferencing services. In March, 2020 (and revised again in July), the US Food and Drug Administration (FDA) also issued guidance on protecting patient safety during the COVID-19 pandemic.
Major Disruption: Physical Distancing
Physical distancing to protect patient and researcher safety has been one of the major disruptions to clinical trial research during COVID-19, but according to Kevin Sheth, chief of neurocritical care and emergency neurology at Yale University, CT, USA, and a principal investigator, many of these changes could have been made long ago. “Telemedicine technology has been around for 10, 15, 20 years”, Sheth told The Lancet. “In many cases, the barriers to incorporating telemedicine more widely into clinical practice really have been in large part administrative and bureaucratic, having to do with cost and reimbursement—not because of some conceptual or technological limitation. The same is true in the clinical research world.”
Serious Structural Flaws Exposed
The slowdown or cancellation of trials will have a disproportionate effect on early career researchers, and even those who can work from home—statisticians and epidemiologists—face the same difficulties that many have in balancing work and home life, which is especially true for those raising children, the effect of which still disproportionately falls on women.
The pandemic has been devastating around the world and has exposed some serious structural flaws in our response. But the clinical trial response is in part encouraging. Ongoing trials in many cases shifted and made alternative plans in conjunction with funders and institutions. New trials to begin to address COVID-19 were fast tracked and numerous existing inefficiencies were identified and streamlined. Since the emergence of COVID-19 in December, 2019, 2995 clinical trials related to COVID-19 have been registered with ClinicalTrials.gov.
Protecting Future Clinical Trials
The disruptions to patients, researchers, and institutions have been numerous, and will leave a lasting effect on research that was ongoing before the pandemic. However, Health Affairs posted a blog that examined ways to maximise the utility of data collected by stopped trials and looked forward to ways to protect trials from similar disruptions in the future, such as decentralizing trial locations out of a few major urban centres.
Clinical trials are an essential tool in medical research, but COVID-19 has exposed ways that their design, conduct, and reporting could be improved. In the future, it will be important for the conduct of research to incorporate those lessons to ensure the highest quality of research.
Call to Action: Recently, TrialSite News reported on the growing number of virtual trials as organizations battle the effects of COVID-19. For more information, follow the link, and sign up for our Daily Newsletter for future updates.