OBJECTIVES : As researchers have focused on finding effective treatments and vaccines for COVID-19, clinical trials for all other studies in the US face an abrupt new reality that raises critical questions about how to continue their clinical programs. This metanalysis assesses the fundamental, logistical and behavioral barriers to continuing clinical research during the pandemic and discusses their short- and long-term impact to the sector.

METHODS : A comprehensive review of published research, articles and regulations was conducted to understand the changing landscape of non-COVID-19 US clinical trials during the pandemic.

RESULTS : Impacts to clinical trial execution include heightened risk of patient drop out, study noncompliance and reduced patient enrollment. New patient enrollment year-over-year was down 65% worldwide in March 2020. Digital capabilities including telemedicine visits, remote monitoring, eConsent and data collection tools are being used in response to these challenges.

CONCLUSIONS : While many of these enablers are not novel – the FDA, for example, recommended a shift to remote monitoring for clinical trials back in 2013 – they have not yet been widely adopted. The COVID-19 environment, however, has accelerated the adoption of new technologies and heightened the focus on patient data protection. In turn, it has presented an opportunity for sponsors, sites and investigators alike to optimize the research business model, deliver value more efficiently and expand trial access. Amid the uncertainty brought on by the COVID-19 pandemic, organizations that invest in a participant-first approach that capitalizes on new methods of delivery will be well-poised to realize time and cost savings, patient safety improvement and participant diversity increases — now and in the long-term, beyond COVID-19.