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COVID-19: Advice for Clinical and Translational Researchers

Covid 19 Advice For Clinical And Translational Researchers Web

COVID-19 is transforming how academic medical centers (AMCs) train future healthcare providers, deliver clinical care, and conduct research. Medical researchers are operating under circumstances requiring enhanced vigilance by all healthcare system players, and research organizations will need to adhere to a cohesive strategy that resonates with the rest of the AMC.

Given COVID-19’s exponential infection rate, ECG recommends all medical research stakeholders follow these high-impact methods to protect their research enterprise.

  • Focus on stable studies that are well under way. Prioritize existing late-stage trials that will make a significant impact on human life. For trials currently in phase one or two of the Food and Drug Administration (FDA) Drug Approval Process (see figure 1), pause and revisit them when the pandemic is under control. Don’t pursue new trials unless they are fast-tracked for approval and have the potential to immediately help patients (i.e., COVID-19 test kits and vaccinations). Most recently, Abbott received an emergency authorization from the FDA for its COVID-19 test and plans to begin shipping 1 million tests per week.

    Figure 1: FDA Drug Approval Process

    • Generate confidence among trial participants. Patients often turn to clinical trials as a last attempt to find a solution to life-threatening illnesses, and many of them may be relying on clinical testing within AMCs. Research organizations and trial sponsors should alleviate patient risk and concern by ensuring them that urgent clinical trials can continue to safely operate under the current circumstances. Clinical researchers also need to determine whether they wish to test for COVID-19 or screen for symptoms before trial enrollment. For prospective trial enrollees, or those currently undergoing phase one treatment that may no longer be available at the research site, a temporary but effective alternative treatment plan should be developed in coordination with the patient’s care provider. Among many other major pharmaceutical producers, Pfizer is continuing recruitment of patients for new and ongoing studies that involve life-threatening conditions.
    • Make use of remote clinical trials and other technology. Adopt novel methods to maintain select patient trials that must continue during the pandemic. Technology such as virtual study visits, live videoconferencing, asynchronous video, remote patient monitoring, and mobile health are especially useful in today’s environment to facilitate ongoing research. Additionally, use technology to break down barriers that inhibit certain patients from being seen in the clinical trials process. This includes simple technology such as e-consent, which can be conducted through DocuSign accompanied by video conferencing, to more detailed, fully packaged software solutions. These more sophisticated solutions may utilize medical devices, biowearables, telehealth, and patient home connection, and integrate with clinical trial management systems. Figure 2 displays Harvard Business School’s key domains of clinical trials that can be accelerated using technology.
    Figure 2: Software-Enabled Clinical Trials

    • Bolster preparation and protection of research staff. Maximizing the safety of the research team is paramount to successful clinical research during a pandemic. Based on advice from the NIH, investigators should consult with their organizational leadership and institutional review boards about potential measures to protect participants and research staff. Additionally, responses from AMCs and other research groups have varied from mandatory suspension of research involving human participants (except when this increases risk to participants) to relying on principal investigator discretion. Moreover, personal protective equipment (PPE) is in high demand and should be rationed as appropriate between researchers and clinical staff who are testing and caring for patients with COVID-19. The Defense Production Act (DPA) directs private sector companies to make enough PPE for a national emergency and maximize the availability of raw materials. The DPA also allows for healthcare workers to use N95 masks approved by the National Institute for Occupational Safety and Health, as opposed to only those approved by the FDA.
    • Develop an integrated AMC COVID-19 response strategy. Strong, top-level leadership is needed to create a cohesive pandemic response and to ensure the tripartite mission of AMCs is upheld. Ensure that response goals are formed by a committee of experienced, well-represented, and diverse AMC leaders who recognize and understand response interdependencies. Additionally, research leaders must present their response priorities to AMC leadership for pressure-testing and support clinical and education leaders in their response planning as well. Researchers should also be part of daily command center meetings to monitor progress of COVID-19 response-related milestones, risks, and issues. While the enterprise-wide communication team must take ownership in creating awareness for overall response strategy, research leaders should also reinforce messaging about integrated COVID-19 response planning to their research units. Finally, research institutions and sponsor organizations developing countermeasures against the COVID-19 pandemic should work closely with regulators to ensure they are maintaining the right balance between accelerating delivery of new therapies while upholding the rigorous standards for clinical testing.

    A thriving hub of medical research fundamentally necessitates investment in core capabilities and strong partnerships. However, with the onset of a global pandemic, operating under the status quo is not possible. Success in clinical and translational research will require swift and impactful decision-making. By enacting both practical and innovative solutions, research organizations will ensure they will get through this trying period and protect their long-term sustainability.

    ECG continues to monitor our country’s response to the COVID-19 pandemic. Visit our COVID-19 thought leadership page regularly for trusted advice on how healthcare leaders and providers can weather this crisis.

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