How I Do It: Restarting Respiratory Clinical Research in the Era of the COVID19 Pandemic.

The clinical research we do to improve our understanding of disease and development of new therapies has temporarily been paused or delayed as the global healthcare enterprise has focused its attention on those impacted by COVID-19. While rates of SARS-CoV-2 infection are decreasing in many areas, many locations continue to have a high prevalence of infection. Nonetheless, research must continue and institutions are considering approaches to re-starting non-COVID related clinical investigation. Those restarting respiratory research must navigate the added planning challenges that take into account outcome measures that require aerosol generating procedures. Such procedures potentially increase risk of transmission of SARS-CoV-2 to research staff, utilize limited personal protective equipment, and require conduct in negative pressure rooms. One must also be prepared to address the potential for COVID-19 resurgence. With research subject and staff safety and maintenance of clinical trial data integrity as the guiding principles, here we review key considerations and suggest a step-wise approach for resuming respiratory clinical research.