Critical Components of Successful Clinical Trials
Designing and managing multisite clinical trials is quite complex, issues can range from the question selected to finances. Investigators Rebecca Aslakson, MD, PhD, FAAHPM, FCCM, and Michael Avidan, MBBCh, FCA SA, attempted to breakdown the complexity during the session, “Leading Multisite Perioperative Clinical Trials: What I Know Now but Wish I Had Known,” held on Sunday, March 20 at the IARS 2022 Annual Meeting. They shared their experiences and insights for running successful multisite clinical trials.
Dr. Rebecca Aslakson, Associate Professor of Anesthesiology, Perioperative and Pain Medicine and Division Chief of Critical Care Medicine-Anesthesia at Stanford University School of Medicine, launched the discussion. She explained that designing randomized control trials (RCTs) requires determining the level of randomization, deciding whether the trial will be explanatory or pragmatic, picking comparators, and specifying outcomes. Randomization can occur at the level of the patient, provider, or site and warrants consideration of the intervention nature and site. According to RWE Navigator, explanatory trials can be conceptualized as efficacy trials while pragmatic trials can be conceptualized as effectiveness trials, so the type selected depends on the study goal. The selected comparators should be well-defined and real-life concepts. Finally, she pointed out that study outcomes are critical and should be measurable.
She cautioned attendees to be aware of project finances. Individuals managing finances throughout the course of the project can change, so an investigator may be the only individual fully aware of the financial history of the project. In closing, Dr. Aslakson advised to “keep experienced experts close and don’t be afraid to ‘phone a friend’ with questions.” After all, managing a multisite trial is complex and requires a lot of support!
Dr. Michael Avidan, Dr. Seymour and Rose T. Brown Professor of Anesthesiology and Head of the Department of Anesthesiology, wrapped up the panel. According to the National Institutes of Health (NIH), “pragmatic clinical trials are performed in real-world clinical settings with highly generalizable populations to generate actionable clinical evidence…They present an opportunity to efficiently address critical knowledge gaps and generate high-quality evidence to inform decision-making.”
In designing clinical trials, he emphasized picking questions that are important not only to the investigator, but also to patients and funders. Publishing the study protocol can provide a way to maintain integrity of the study and maintain accountability to the standards determined beforehand. According to Dr. Avidan, one of the most valuable lessons of running multisite trials is team science. In other words, working with great people is essential to successful research.
In his talk, he also noted three areas in which clinical trials typically fail. These areas include 1) recruitment, 2) inability to deliver the intervention with fidelity, and 3) incomplete achievement of the outcome. If a study can accomplish these three components, then the researcher can be confident in delivering a successful trial.