The Utility of Adaptive Design Clinical Trials for Vaccines
Author(s)
Amit Dang, MD, Dimple Dang, MBA, Vallish Basavapatna Nagendra, MD.
MarksMan Healthcare Communications, Hyderabad, India.
MarksMan Healthcare Communications, Hyderabad, India.
Presentation Documents
OBJECTIVES: Adaptive design clinical trials (ADCTs) offer a flexible and efficient alternative to traditional randomized clinical trials (RCTs) by allowing pre-specified changes to study design based on interim data analysis. This adaptability is particularly beneficial in vaccine development, as it enables rapid modifications in response to emerging data, thereby accelerating the identification and optimization of effective vaccine candidates, especially during public health emergencies like the COVID-19 pandemic.
METHODS: A pragmatic literature search of published papers on ADCTs was performed in the context of vaccine development.
RESULTS: Since their evolution in the 1970s, ADCTs have introduced various methodologies, such as adaptive randomization and group sequential designs, to enhance trial flexibility and efficiency. These designs are tailored to different research needs, allowing modifications in allocation, sampling, study termination, and hypotheses, making them adaptable across various clinical scenarios. ADCTs can effectively address many challenges in vaccine development by enabling quicker, more flexible responses to unanticipated events, thus conserving time and resources. Recognizing their potential, regulatory bodies like the USFDA and EMA have issued detailed guidelines to ensure the integrity and validity of ADCTs, stressing the importance of early discussions and precise justifications. However, the successful implementation of ADCTs hinges on increasing stakeholder awareness, as many—including regulatory bodies, researchers, and ethics committees—often struggle to fully understand the complexities of these designs.
CONCLUSIONS: As ADCTs continue to evolve, understanding and addressing these challenges will be key to their broader adoption and successful application in clinical research.
METHODS: A pragmatic literature search of published papers on ADCTs was performed in the context of vaccine development.
RESULTS: Since their evolution in the 1970s, ADCTs have introduced various methodologies, such as adaptive randomization and group sequential designs, to enhance trial flexibility and efficiency. These designs are tailored to different research needs, allowing modifications in allocation, sampling, study termination, and hypotheses, making them adaptable across various clinical scenarios. ADCTs can effectively address many challenges in vaccine development by enabling quicker, more flexible responses to unanticipated events, thus conserving time and resources. Recognizing their potential, regulatory bodies like the USFDA and EMA have issued detailed guidelines to ensure the integrity and validity of ADCTs, stressing the importance of early discussions and precise justifications. However, the successful implementation of ADCTs hinges on increasing stakeholder awareness, as many—including regulatory bodies, researchers, and ethics committees—often struggle to fully understand the complexities of these designs.
CONCLUSIONS: As ADCTs continue to evolve, understanding and addressing these challenges will be key to their broader adoption and successful application in clinical research.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
SA34
Topic
Study Approaches
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, STA: Vaccines