Emerging Trends in Adaptive Clinical Trial Designs Benefits and Limitations
INTERNATIONAL JOURNAL OF TREND IN SCIENTIFIC RESEARCH AND DEVELOPMENT, 7 (4):
591-594 (August 2023)Abstract
Adaptive clinical trial designs have gained significant attention in recent years due to their potential to optimize the efficiency and effectiveness of clinical research. These innovative trial designs offer the flexibility to modify study parameters based on accumulating data, thus enabling researchers to make informed decisions in real time. This review article explores the emerging trends in adaptive clinical trial designs, delving into their benefits and limitations. The benefits of adaptive trial designs include the ability to shorten study duration, reduce sample size requirements, and enhance patient safety by allowing adaptations based on interim results. Adaptive trials also enable researchers to address multiple study objectives within a single trial, making them a valuable tool for exploring multiple treatment strategies simultaneously. Additionally, these designs facilitate the incorporation of new information and treatments as they become available, ensuring that patients receive the most relevant and effective interventions. Despite their potential advantages, adaptive trial designs come with certain challenges and limitations. The need for sophisticated statistical methods, complex trial logistics, and potential operational hurdles can pose difficulties during trial execution. Furthermore, regulatory considerations and the need for rigorous control over the adaptation process require careful planning and clear communication with regulatory authorities. In this review, we discuss various adaptive trial design types, such as group sequential designs, sample size re estimation, adaptive randomization, and Bayesian adaptive designs. We also highlight real world examples of successful adaptive trials in different therapeutic areas and discuss the key considerations for implementing these designs effectively. A. Shireesha | Kavya Kalva "Emerging Trends in Adaptive Clinical Trial Designs: Benefits and Limitations" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-4, August 2023, URL: https://www.ijtsrd.com/papers/ijtsrd59755.pdf Paper Url:https://www.ijtsrd.com/other-scientific-research-area/other/59755/emerging-trends-in-adaptive-clinical-trial-designs-benefits-and-limitations/a-shireesha