By using accumulating data to make pre-specified changes to the course of a study, adaptive trial designs increase flexibility, help optimize resources, and may require fewer participants.
TORONTO (PRWEB) April 16, 2020
Join Abie Ekangaki, PhD, Vice President, Statistical Consulting, Premier Research and Peter Larson MD, Executive Medical Director, Premier Research in a live webinar on Monday, May 4, 2020 at 11am EDT (4pm BST/UK).
Targeted therapies and immunotherapies have changed not only cancer treatment paradigms, but also historical approaches to clinical trial design, especially in early development. Traditionally, early phase oncology trials have been focused on dose optimization, toxicity, and broad response signals. However, with the growth of personalized medicine, many early phase studies also emphasize identifying those patients most likely to respond to the investigative drug.
Fixed design clinical trials that may have been appropriate for cytotoxic chemotherapy agents may be inadequate for targeted therapies and immunotherapies that have unique toxicity profiles and mechanisms of action. Adaptive trial designs, which allow for planned adaptations to be made to certain aspects of a trial, may help to address challenges inherent to early phase oncology clinical trials. By using accumulating data to make pre-specified changes to the course of a study, adaptive trial designs increase flexibility, help optimize resources, and may require fewer participants.
Adaptive trial designs enable real-time modifications while a study is ongoing, such as the ability to select biomarker subgroups that identify patients more likely to respond to treatment or to dynamically adjust dose schedules or even drop doses as patients are enrolled. In an environment where nearly one-third of drugs entering phase II studies fail to progress, adaptive trial designs offer an opportunity to gain early insight into the likelihood of later stage success.
This webinar will explore the role of adaptive trial designs in early oncology studies and how sponsors can leverage these designs to optimize their development programs.
For more information or to register for this event, visit The Role of Adaptive Trial Designs in Early Oncology Studies: Optimizing Flexibility and Agility.
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