Confronting Obstacles in Critical Care Trials

Renee D. Stapleton

Renee D. Stapleton

Successful completion of critical care trials is fraught with barriers. These barriers may include engaging with surrogates, as patients often cannot consent. Patients’ health can quickly take a turn for the worse and eliminate them from trials, resulting in missing data. Populations also are extremely heterogeneous.

“We also lack good intermediate endpoints, rendering phase II moderate-size studies nearly useless to perform in some cases,” said Renee D. Stapleton, MD, PhD, ATSF, associate professor of critical care medicine/pulmonary disease at the University of Vermont Medical Center in Burlington. “We hope to address all of these issues in this session.”

Dr. Stapleton is a chair of today’s session on addressing the challenges that come with conducting randomized controlled trials in a critical care population, especially as they relate to recruitment, retention, and generalizability, and how they may contribute to the paucity of proven efficacious interventions in the ICU.

Using recent examples of critical care trials, this session will appeal to clinicians who seek greater insight on interpreting and applying literature to their patients.

“This session is devoted uniquely to critical care randomized trials and discussing troubleshooting their implementation and conduct, rather than focusing on interpreting the results of particular studies about a specific topic,” said Dr. Stapleton.

Dr. Stapleton said the session also will provide a patient perspective, “which is always insightful and reminds us why we do what we do.”

Eileen Rubin, JD, executive director of the ARDS Foundation in Northbrook, Illinois, and acute respiratory distress syndrome survivor, will tell her story of what it was like participating in an ICU trial.

Dale M. Needham, MD, PhD, medical director of the Critical Care Physical Medicine and Rehabilitation Program and professor of medicine at John Hopkins University, will identify methods to engage patients over a long period of time to gather long-term outcomes.

Challenges in Conducting and Interpreting ARDS and Sepsis Randomized Clinical Trials (B89)

2:15-4:15 p.m., Monday

Dallas Ballrooms A-C (Level 3), Omni Dallas Downtown

“It’s easy for participants to ‘fall off the radar’ once the critical illness is over, and Dr. Needham will discuss strategies to retain these participants,” Dr. Stapleton said.

Additional presentations during the session will include how to nudge surrogate decision-makers toward participating in critical care trials, lessons learned from special issues in pediatric critical care trials, and the evolution of modern critical care trials from the past to the future.

“Critical care trialists will be able to utilize these strategies in their day-to-day work to successfully implement, conduct, and complete critical care RCTs,” said Dr. Stapleton.

Dr. Stapleton said attendees who do not conduct RCTs as part of their work can still use these lessons learned to help their colleagues enroll in trials, retain participants over time, and interpret published RCTs.