The Continuation of Medical Research While Participants Practice At-home Isolation and Social Distancing
At-home isolation and social distancing orders for millions of Americans are a vital part of slowing the COVID-19 pandemic. Most of our daily activities are on hold or modified for the foreseeable future. But medical research is a crucial pursuit that continues despite the current environment.
Medical research is critical for detecting, diagnosing, reducing, and treating disease. Still, the global pandemic has the potential to disrupt and delay vital research. To help the research community navigate these unprecedented times, the Food and Drug Administration (FDA) has issued new guidance for continuing medical research during the pandemic. The goal is to protect the safety of trial participants and study personnel while maintaining research integrity.
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. During a global pandemic and home-isolation, though, a range of problems comes up. Study participants often can’t travel for traditional in-person visits. The facilities used for study visits may not be open or accessible. Study staff may not be available, since they’re reallocated to other duties. And study visits to a facility expose both the participant and staff to more people, raising the risk of COVID-19 infection.
With patient safety and well-being guiding every research decision, the FDA’s new guidance supports the continuity of research. It encourages industry and investigators to explore alternatives to in-person visits, or locations other than hospitals and medical centers. Medical facilities may quickly become overwhelmed treating COVID-19, so sponsors need provisions in place to move study visits to other participating sites, non-treatment facilities such as medical labs, or at-home visits where possible.
Study sponsors, investigators, and clinical trial researchers are working with investigational review boards to plan how to modify existing research protocols and avoid potential disruptions. Industry leaders are encouraged to use alternative resources that weren’t already part of the clinical trial, through protocol amendments that make the necessary changes to the study process. At-home study visits offer a viable way to complete milestone monitoring and safety review visits, patient-reported questionnaire assessments, and non-invasive specimen collection, when feasible.
We don’t yet know how severe or long-lasting the pandemic will be. But medical research difficulties are expected to intensify for ongoing clinical trials, long-term safety monitoring initiatives, and new research. So far, patients haven’t hesitated to participate in medical research, though they are concerned about visiting medical facilities and 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 exposure to COVID-19.
Protecting patient safety, welfare, and rights while maintaining research integrity requires case-by-case, trial-by-trial decisions. Still, the FDA recognizes that sometimes the best decision for patient well-being is to continue medical research with modified study conduct and protocols, while staying compliant with good clinical practice (GCP) guidelines. One possible path forward is to add at-home study visits to existing protocols and future research. The COVID-19 pandemic is devastating, and home-isolation is a life-disrupting, necessary responsibility. But that doesn’t mean medical research has to stop moving forward. It’s possible to safeguard the health and well-being of study participants, minimize risks to trial integrity, and maintain both study continuity and GCP compliance during these unprecedented times.
REFERENCES
Cohn-Emery, D. Challenges for Clinical Trials and Treating Patients With Cancer in Light of the Coronavirus. Target Oncology. Challenges for Clinical Trials and Treating Patients With Cancer in Light of the Coronavirus. Accessed March 30, 2020.
FDA guidance on conduct of clinical trials of medical products during COVID-19 Pandemic. FDA website. fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic. Published March 18, 2020. Accessed March 30, 2020
GlobalData Healthcare. Clinical Trials Arena. The impact of the Covid-19 pandemic on clinical trials. https://www.clinicaltrialsarena.com/comment/covid-19-pandemic-clinical-trials/. Accessed March 30, 2020.
Interim guidance for clinical trial activities affected by the new coronavirus. CTEP website. ctep.cancer.gov/content/docs/Memorandum_on_Interim_Guidance_for_Clinical_Trial_Activities_Affected_by_the_Novel_Coronavirus-3-13-2020.pdf. Published March 13, 2020. Accessed March 30, 2020.
