Authors: Brenna et al.
The Daily Dose, IARS, Friday, May 8, 2026
Key Points
Successful clinical trials often look simple after publication, but the process behind them usually involves false starts, funding challenges, regulatory hurdles, recruitment problems, and difficult strategic decisions.
Jessica Spence, MD, PhD, shared lessons from leading B-Free, a large multicenter cardiac surgery trial involving 20 North American centers and 19,768 patients.
Ashish Khanna, MD, MS, discussed lessons from ATHOS-3, an industry-funded trial that evaluated angiotensin II for vasodilatory shock.
Both speakers emphasized that mentorship, persistence, team building, clear writing, site selection, ownership of data, and protected time are essential for early-stage investigators.
Summary
This IARS Daily Dose article reviewed a Scholars’ Day session from the 2026 IARS and SOCCA Annual Meeting focused on the realities of launching and leading a first clinical trial. The article emphasized that published trials often appear clean, direct, and inevitable, but the actual process behind them is usually much more complicated. Investigators must navigate setbacks, regulatory barriers, funding attempts, protocol decisions, team coordination, and operational challenges, especially when trials involve multiple centers or industry partnerships.
The first presentation was given by Jessica Spence, MD, PhD, who discussed lessons from leading a multicenter trial. Her team recently completed B-Free, a pragmatic, multiple-period, cluster randomized crossover trial conducted across 20 North American cardiac surgical centers. The study included 19,768 patients and compared liberal versus restrictive intraoperative benzodiazepine administration protocols. The trial found that restricting benzodiazepines did not significantly reduce postoperative delirium.
Dr. Spence used this experience to outline practical advice for investigators planning their first trial. Her recommendations included finding multiple mentors, choosing a research question that truly matters to the investigator, keeping the design simple, accepting feedback from mentors, team members, and patients, building a team with both formal expertise and practical experience, and selecting partner sites with genuine buy-in. She also emphasized that delays and rejection are part of the process, multicenter research is a team effort, writing clearly and frequently is essential, and investigators must protect time for deep work.
The second presentation was delivered by Ashish Khanna, MD, MS, who discussed his experience leading an industry-funded trial. His first major industry-supported trial was ATHOS-3, funded by La Jolla Pharmaceutical Company and published in the New England Journal of Medicine. ATHOS-3 showed that angiotensin II can increase blood pressure in patients with vasodilatory shock when conventional therapies fail. Dr. Khanna described the trial as a major step in a broader translational research pathway and emphasized the importance of persistence, mentorship, and resilience during difficult recruitment and execution phases.
Dr. Khanna’s advice to early investigators focused on the unique pace and demands of industry-supported research. He encouraged investigators to be nimble, anticipate problems before they occur, aim for excellence, take ownership of trial data rather than only the results, and think of each project as part of a larger “plan-grant-next” cycle. In his view, a first trial should not be seen as an isolated project, but as one step in a larger scientific program.
What You Should Know
This article is especially useful for trainees, junior faculty, and early-stage anesthesiology investigators who want to understand what clinical trial leadership actually requires. The central message is that successful trials depend on much more than a good idea. They require mentorship, leadership, organization, judgment, persistence, and the ability to manage setbacks.
For anesthesiology research, the lessons are practical. Multicenter trials require simple protocols, committed partner sites, strong communication, and realistic expectations about delays. Industry-funded trials may move quickly and require investigators to anticipate operational problems early. In both settings, the investigator must build the right team, own the work, write clearly, and protect time for focused effort.
Overall, the article reminds readers that the obstacles involved in launching a clinical trial are not distractions from the work. They are the work. Understanding those challenges early can help young investigators become more successful trial leaders.
Thank you to IARS and The Daily Dose for allowing us to summarize and share this article.