Overcoming Study-Patient Burdens in Medical Research During the Pandemic

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.

Study sponsors, investigators, and clinical trial researchers are planning how to modify existing research protocols in consultation with investigational review boards to avoid potential medical study disruptions. Industry leaders are encouraged to use alternative resources that weren’t already a part of the clinical trial via protocol amendments to make the necessary changes to the study process. At-home study visits are viable alternatives to complete milestone monitoring and safety review visits, patient-reported questionnaire assessments, and non-invasive specimen collection, when feasible.

Telemedicine and home visits used to be viewed as risky, but now the industry is looking at telemedicine and home visits as a risk mitigation strategy. In-home specimen collection sends mobile health care workers to visit the patient in the comfort of their own home, allowing research and clinical trials to continue.

The severity and duration of the pandemic are yet unknown; however, medical research difficulties are anticipated to intensify for on-going clinical trials, long-term safety monitoring initiatives, and for new research. Thus far, patients have not had hesitancy to participate in medical research, although they are concerned about appearing at medical facilities with the need to practice social distancing. Some patients have already stopped coming to clinics for their study visits due to local travel restrictions and fear of exposing themselves to COVID-19. But looking past COVID-19, will patients be more cautious and hesitant to participle in the future?

Methods to protect the patient’s safety, welfare, and rights while maintaining research integrity is made on a case-by-case and trial-by-trial basis – however, the FDA recognizes that sometimes the best decision for the well-being of the patient is to continue medical research with modified study conduct and protocols while maintaining compliance with good clinical practice (GCP) guidelines. One possible avenue to advance medical research during these unprecedented times is to implement at-home study visits to existing protocols and future research. The COVID-19 pandemic is devastating, and home-isolation is a life-disrupting, social responsibility. However, it does not necessarily mean medical research needs to cease to progress forward. Safeguarding the health and well-being of study participants, minimizing risks to trial integrity, while maintaining study continuity and GCP compliance is possible during these unprecedented times.

References

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Author Biography

Brian Neman serves as the Co-Founder and CEO of Sanguine Biosciences. Brian focuses on all items relating to commercialization and relationships with researchers; he is an adjunct professor of Digital Health at USC, and co-founded Sanguine in 2010 out of his graduate program in healthcare administration at USC. He is also on the boards and committees of various organizations including HD Care, BIOCOM Big Data Committee, and more.