key: cord-0722912-grcjubx1
authors: Byrd, James Brian; Bello, Natalie; Meyer, Michelle N.
title: Pandemic Pandemonium: Pausing Clinical Research During the COVID-19 Outbreak
date: 2020-04-22
journal: Circulation
DOI: 10.1161/circulationaha.120.047347
sha: 98b2f75dbe13bc731e3aa77ae83ef9e18301da48
doc_id: 722912
cord_uid: grcjubx1

nan

participants might avoid academic medical centers and other clinical research institutions during the pandemic, causing protocol deviations that will be avoidable after the pandemic has receded. Other research should be paused not because the pandemic alters the study's risk-benefit ratio but because scarce resources devoted to those studies (eg, skilled personnel, swabs, reagents, mobile devices) are better allocated elsewhere, whether to COVID-19 research or to clinical care.

The same risk-benefit framework suggests that other studies unrelated to the pandemic should continue. For example, the pandemic is unlikely to affect the risk-benefit profile of research conducted entirely online. In other cases, pausing research could cause more harm than good. Canceling study visits abruptly could endanger participants in studies requiring safety checks. 1 If a pause causes the study to fail-for example, because of cost overruns-then any risks or burdens already undertaken by participants might cease to be balanced by societal benefits. Even during a pandemic, other threats to morbidity and mortality remain. Pausing therapeutic trials, which may provide direct benefit to participants, is unlikely to be warranted. Even nontherapeutic studies that advance our understanding of serious conditions may be justifiably continued. Many life-threatening diseases remain fundamentally poorly understood, and a delayed breakthrough will come too late for some patients.

Continued studies should have contingency plans in case the evolving pandemic causes interrupted visits, incomplete data collection, and supply chain interruptions. A study drug may become unavailable during the course of a clinical trial, and a plan must be in place to address this possibility.

Rarely, ongoing research should neither pause nor continue as usual but pivot to address the pandemic. 2 An HIV research network was adapted to study the 2009 influenza pandemic. 3 In such cases, thoughtful interpretation of research regulations and ethics is critical. Researchers leading the Seattle Flu Study wanted to test existing samples for COVID-19 to help define the size of the outbreak in the state but were reportedly stymied by regulators who maintained that explicit consent from participants to test for COVID-19 was necessary, as was testing in a laboratory certified by the CLIA (Clinical Laboratory Improvement Amendments of 1988). Although consent terms generally must be respected, those that were included reflexively and that were likely unimportant in participants' decision to enroll in the study should not be dogmatically adhered to when overriding them does not significantly increase participant risk and could substantially benefit society or participants themselves. 4 Although Centers for Medicare and Medicaid Services regulations prohibit non-CLIA laboratories from returning individual results for the purpose of diagnosis, it is a myth-which can become tragic during a pandemic-that they prohibit return of results for other purposes, including to provide research participants notice that they might be at risk and should consider clinical testing. 5 In these circumstances, clinical researchers will be faced with challenges and will need to make difficult decisions. When research is paused, there will be human costs to trainees and technicians whose careers and families depend on these positions. As has been done in Seattle, we should find novel ways to divert this talent pool and put their skills to use in other ways that aid humanity, without subjecting to them to COVID-19-related risks.

Clinical research in times of pandemics

Clinical research networks are key to accurate and timely assessment of pandemic clinical severity

Outcomes of influenza A(H1N1)pdm09 virus infection: results from two international cohort studies

Practical tips for ethical data sharing

A Faustian bargain that undermines research participants' privacy rights and return of results

Dr Byrd is supported by grant HL128909 from the US National Institutes of Health. Dr Bello is supported by grant HL136853 from the US National Institutes of Health and by the Katz Foundation. Dr Meyer has nothing to disclose.