key: cord-1014578-riqm5p30
authors: Giordano, Nicholas J.; Alanis, Naomi; Frey, Jennifer A.; Hall, Grace L.; Coates, Wendy C.
title: The Fine Balance: Adapting Clinical Research into COVID‐19 Response
date: 2020-06-17
journal: Acad Emerg Med
DOI: 10.1111/acem.14059
sha: 4aba42740b51eb48d22c7f7166b68e2f43814380
doc_id: 1014578
cord_uid: riqm5p30

Quality clinical research remains a high priority during the severe acute respiratory syndrome coronavirus‐2 (SARS‐CoV‐2) coronavirus disease (COVID‐19) pandemic response, however, the logistical barriers of conducting research across institutions with differing departmental policy responses and varying resources is a documented problem.

Quality clinical research remains a high priority during the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) coronavirus disease (COVID-19) pandemic response, however, the logistical barriers of conducting research across institutions with differing departmental policy responses and varying resources is a documented problem. 1, 2 The COVID-19 pandemic has resulted in a surge of more than 1,000 newly formed clinical trials registered on clinicaltrials.gov with "COVID-19" in their study title as of May 8, 2020 . While the need for new and innovative research remains high, traditional operations to support the execution of these studies must rapidly evolve to overcome the newly formed barriers of clinical research. 3 Most notably, reserves of personal protective equipment (PPE) dwindled and have forced hospitals to re-evaluate the distribution of these supplies in an effort to conserve resources and minimize waste. Due to the lack of PPE, the logistics of screening and consenting patients in the emergency department (ED) must be revised while continuing to make safety of colleagues, patients, and the general public a main priority. Best practices need to be established to adapt clinical research into the rapidly changing environment of the COVID-19 response.

As the pandemic continues, new recommendations for conducting research have been made by the National Institutes of Health (NIH) and the United States Food and Drug Administration (FDA) for the COVID-19 public health emergency. These recommendations suggest that all ongoing studies during the COVID-19 pandemic should incorporate procedures that are compliant with regional management policies for controlling the spread of the disease, however, the logistics of executing that research is left to individual institutions. 4, 5 We are hesitant to provide specific examples of studies relevant to emergency medicine that should be conducted during the COVID-19 pandemic due to the context-dependent issues across institutions and for fear that while an example might be suitable in one setting, it may be deemed inappropriate in another. Some variables such as the seriousness of the disease, investigational product supply, and whether there are reasonable alternative treatments will be relatively consistent across institutions, but other variables such as viability, available resources and the ability to safely administer an interventional product might vary widely across sites. Instead, we want to detail who should be judging the criteria to continue research so that individual institutions can make an informed decision that best suits their specific scenario. The FDA has recommended that

This article is protected by copyright. All rights reserved sponsors, in consultation with clinical investigators and Institutional Review Boards/Independent Ethics Committees judge whether a study should be open to enrollment during the pandemic. 4 Ongoing clinical trials raise an additional area of concern during pandemic response. Although there is some guidance from local and national organizations, the assessment of an appropriate response weighing ethical principles, staffing constraints, risk to participants and ultimately the course of action to take resides on the principal investigator and the Institutional Review Board. 4, 5 It is widely believed that critical clinical care research during a pandemic must have a different approach than during non-emergent circumstances. 6 Logistical adaptations to mitigate risk for patients, healthcare workers and the general public is paramount for fostering an environment for clinical research to continue during a pandemic. A review of the literature through PubMed using the search terms "COVID-19 research guidelines" and "COVID-19 research best practices" did not produce any guidelines or best practices pertaining to navigating the logistical barriers that emergency medicine (EM) research faces during the COVID-19 response.

Re-evaluating how research is conducted in the ED and redefining clinical research operations has been necessary. Our objective was to evaluate the essential elements needed to keep clinical research operations open and active to enrollment, and then systematically determine how research teams could immediately adapt these elements to the current pandemic environment while still maintaining safety measures for our workers, patients, colleagues, and families. The term "essential elements" was defined by our working group as the necessary measures that needed to be taken to conduct vital research operations. While financial support is a critical and a core component of research logistics, it was decided that funding was a byproduct of research enrollment and that defining safety measures for staff, colleagues and patients should take priority, however, we acknowledge that in the long-term funding issues must be addressed to maintain research viability. Participation is open to all SAEM members, but was designed specifically to engage non-clinical

This article is protected by copyright. All rights reserved research staff in the execution of research within EM. On April 22, 2020, the group convened an emergency meeting to discuss operational logistics and share best practices related to staffing, screening, enrolling, and processing of biospecimens during the COVID-19 pandemic. A CRUX chair moderated the session in which each topic was addressed systematically, while providing members a platform to share their institutions' newly adapted procedures and concerns. Following each section, members were able to discuss best practices for each topic. Comments were recorded and subsequently circulated among CRUX members to confirm consensus. Responses were reviewed and collated into recommendations that are summarized by Figure 1 . 

This article is protected by copyright. All rights reserved staff into the ED, virtual study screening through electronic medical chart review or analyzing electronic screening surveys via tablets in patient rooms were recommended as remote alternatives to in-person discussions for determining study eligibility. Action at a distance may continue to be the new normal for clinical researchers in the time of COVID-19. 7 Study enrollment procedures required the greatest number of modifications during the pandemic response. Institutions with many COVID-19 research studies should incorporate a COVID trials' triage system, which could be as simple as a phone number to call at time of screening, staffed by a clinical research professional versed in all the ongoing research studies in the ED. The triage system can act as a central processing unit for identifying which research study would be most beneficial for the patient, the institution and the pursuit of knowledge. To save PPE and reduce the number of people exposed to COVID-19, all institutions should consider implementing telemedicine devices, whether it be a tablet, smartphone, or a land-line telephone to gauge a patient's interest in participating in a research study without making physical entrance into the room. Some institutions reported utilizing research physicians who are working clinically to conduct discussions of consent; while this is convenient and can minimize excess contact with a patient, it is not sustainable as research efforts grow. Teleconsents were found to be most well-received at hospitals that already have telemed services integrated into their current standard of care. 8 Paperless enrollment is recommended, but when not possible the recommendation to use disposable pens, sterilize clipboards and minimize entrances into the patient room were cited as strategies that could aid in infection control. Where appropriate, instead of leaving to make a photo copy of a signed consent form, consider holding the document up to the window and having a colleague taking a photo using a HIPAA compliant device to document consent. If the paper consent form must be removed from a patient's room, do so in a sealed bag that could be decontaminated upon exit.

Procedures for processing biospecimen samples and study data needed to adapt to newfound recommendations of social distancing for COVID-19. At the consequence of cross-functional training, larger institutions with multiple people working per shift should look to have individual task assignments with the same employees working together during shifts (i.e. team A or B). Staff working

This article is protected by copyright. All rights reserved in the ED should have minimal movement throughout the hospital and should be limited to duties within the ED. Administrative tasks or lab processing should ideally be done by another team member. Coordination of necessary work among teams should be done to minimize entry or egress to parts of the hospital as well as the individual patient rooms. Trip consolidation should be applied where enrollment windows permit. Contact with one another when not necessary (i.e. biospecimen sample handoff) should be replaced with a designated, safe location drop-off. Communication of staff location should be maintained throughout the workday to minimize staff cohorting in laboratory or office settings.

With the outbreak of COVID-19, we have seen unprecedented changes, innovation and reevaluation of our healthcare system. During these tumultuous times, one thing that remains steadfast is that healthcare workers in the ED continue to do what they do best -adapting and overcoming any situation that presents itself. Some things will be forever changed by this pandemic, but the innovations and re-evaluations of workplace efficiencies and operational logistics can propel us to the next level of innovative care for the future. We advocate that every institution have an open discussion of their essential research operations and use some of the recommendations presented here to find a revised, innovative solution to the challenges presented by COVID-19 that best suit their research endeavors. Figure 1 . A summary of the CRUX recommendations for research during the COVID-19 pandemic.

This article is protected by copyright. All rights reserved Accepted Article

Clinical Research During a Public Health Emergency: A Systematic Review of Severe Pandemic Influenza Management*. Read Online Crit Care

Bending the Pandemic Curve: Improving Decision-Making With Clinical Research

COVID-19 -List Results -ClinicalTrials.gov [Internet

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency [Internet]. US Food Drug Adm

Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19

Preparedness for clinical research during pandemics: a perspective from the Platform for European Preparedness Against (Re-)emerging Epidemics (PREPARE)

Accepted Article This article is protected by copyright. All rights reserved

Action at a Distance: Geriatric Research during a Pandemic

Teleconsent: A novel approach to obtain informed consent for research