The ATM brings together leading scientists to teach novel regulatory science methodology that supports bringing new health innovations to patients sooner. In a recent live session, the ATM facilitated an engaging discussion on novel approaches to the design of clinical trials, drawing significant enthusiasm from learners in the ATM’s Regulatory Sciences and Health Economics course.
The session was presented by Dr. Jay Park, who is the Scientific Lead and Founder of Core Clinical Services, an Assistant Professor at McMaster University and a Methodologist with expertise in HEOR and clinical trial designs.
Dr. Park addressed the inherent limitations of conventional approaches by advocating for adaptive designs that allow trial modifications based on interim data analysis. This approach introduces a dynamic element into clinical trials, enabling adjustments to sample sizes, trial arms, and other parameters in response to accumulating data, thereby enhancing trial efficiency, ethical standards, and resource allocation.
The presentation covered various adaptive design types, including sequential designs, sample size re-assessment, and response adaptive randomization, each tailored to specific trial needs and outcomes. Emphasizing the intricate planning and collaboration required, he noted the necessity for comprehensive pre-trial simulations, adherence to predefined standards, and transparent reporting guidelines to maintain the scientific integrity and regulatory compliance of adaptive trials. Despite the complexity and increased resource demands of implementing adaptive designs, they have the potential to transform clinical research by offering more flexible and efficient methodologies for exploring medical interventions.
Following the session, the ATM received an influx of positive feedback. Many learners emphasized how eye-opening the topic was, and appreciated the exposure to novel clinical trial methods which are aiming to improve patient care in a more ethical and efficient manner, without sacrificing quality of data. Students also noted that the session provided them with a realization that regulatory agencies are among the various groups that would need to commit to using this design of clinical trials. The ATM thanks Jay Park for the engaging presentation!