Overcoming Study-Patient Burdens in Medical Research During the Pandemic

Written by Brian Neman, Co-Founder & CEO, Sanguine for Pharmaceutical Outsouring

Study-patient recruitment and retention continue to be significant challenges in medical research, and even more so, during the COVID-19 pandemic. The at-home isolation and social distancing orders for millions of Americans is a vital element to slow the COVID-19 pandemic, but the global pandemic has the potential to disrupt and delay vital research. In order to assist the research community in navigating these unprecedented times, The Food and Drug Administration (FDA) has issued new guidance in continuing medical research during the global pandemic to ensure the safety of trial participants and study personnel while maintaining research integrity.

Recruitment and study challenges existed prior to COVID-19. According to a Tufts Center for the Study of Drug Development report, 48% of study sites miss their enrollment targets, and 11% fail to enroll a single patient. This results in the need for study sponsors to nearly double study timelines to meet recruitment criteria. In addition, one third of studies do not receive recruitment support, leaving individual study sites to allocate valuable time and resources to participant recruitment. All told, 80% of studies are delayed due to patient recruitment issues. Aside from patient recruitment challenges, clinical trials have increasing drop-out and lost-to-follow-up rates. The industry expectation is to plan for approximately a 30% drop-out rate; however, trial adherence rates can average 43%-78% in patients with chronic conditions.

Under the traditional model, clinical and translational research requires in-person visits to a medical center or study site for sample collection, patient evaluation, and patient-reported outcome assessments. However, during a global pandemic and home-isolation, a myriad of issues arises. In essence, study participants are unable to travel for the traditional in-person study visits, the facilities used for study visits may not be open/accessible, and study staff may not be available as they are reallocated to other duties. Not to mention, study visits to a facility expose both the study participant and study staff to more people increasing the risk for COVID-19 infection.

With patient safety and well-being leading all research decisions, the FDA’s new guidance supports the continuity of research. It encourages industry and investigators to explore alternatives to in-person visits and/or locations other than hospitals and medical centers. Medical facilities may quickly become overwhelmed to treat COVID-19, and provisions need to be in place to transfer those study visits to other participating sites, non-treatment facilities such as medical labs, or to be at-home visits, if possible.

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