By Dr. Natalia Marder, M.D, Ph.D., Project Director
COVID-19 has impacted the clinical research landscape completely, prompting special attention toward critical care studies that require a nuanced approach to patient centricity and patient safety measures. Through our expertise and experience with critical care studies, we’ve been able to leverage our lessons learned into successful strategies that mitigate risks exacerbated by the pandemic.
Mapping Pathways: A Playbook for Success
The key to the success of critical care studies is close collaboration with the sites starting at the feasibility stage. Understanding patients’ pathways in each hospital is crucial, considering the time limitations in this type of protocol for windows between admission and the enrollment. It is essential to work with sites to help them map these pathways, determining which departments they will use to catch the patients during their eligibility window. An integral part of startup begins with ongoing discussions concerning which alerts could be set-up within the hospital (e.g., for studies that require PCR results for SaRS-CoV-2, alerts for positive COVID-19 tests are a must), and who on their team will be reviewing those alerts, how frequently, and their actions afterwards. Many studies take weeks or even months between site activation and first randomization because the sites are figuring out these pathways. To moderate the tight timelines, sites should be provided with targeted questions, helpful hints, and detailed guidance and manuals. Building a ‘playbook’ of methods and options to present to sites to help optimize their ability to work across departments and keep the study top of mind has been a great strategy in our experience.