2013 Archived Content

SC14 Adaptive Oncology Clinical Trials 

Monday, February 20 | Dinner Short Course, 4:30 – 7:30 pm

Most advanced adaptive designs have been developed for the oncology clinical trials. These include the up-and-down generalization of conventional 3 + 3 dose escalation procedure, accelerated titration designs, continual reassessment methods, and study of specific target patient populations.  Each of these approaches uniquely contributes to some adaptive aspect of the oncology Phase I study, with all focused on dose and schedule determination, patient safety, and limited patient exposure to ineffective doses of investigational agent.

The adaptive design for Phase II trials continues to be the subject of vigorous debate, especially for studies including patients with a specific molecular profiling/genomic biomarker, but with multiple histological subtypes.  Adaptive design, as a more efficient screening tool, continues to learn about the new agents’ activities, identifying the predictive markers in order to apply this knowledge to better treat patients in real time.

Still high attrition rate for new oncology therapeutics in confirmatory phase III studies, coupled with the numbers of new agents to be tested as well as the increasing costs and complexity of clinical trials, further emphasize the critical importance of Phase II adaptive design.
This course will provide an overview of adaptive designs, including their motivation, advantages and challenges. Exploratory adaptive designs, in the context of dose-escalation, seamless Phase I/II designs, Bayesian response adaptive designs, as well as confirmatory adaptive designs, in the context of population enrichment designs and seamless Phase II/III studies, will be described and illustrated using oncology clinical trials.

At the conclusion of this course, participants should be able to:

• Define Adaptive Design and Adaptive Clinical Trials types
• Describe the benefits and challenges of ACTs
• Discuss the emergence of ACTs in the industry
• Recognize potential ACT opportunities
• Know how to evaluate the potential benefits of adaptive designs when planning a trial
• Identify high-level impact of AD on the clinical trial life cycle
• Know what software is available for designing and analyzing adaptive designs


Vlad Dragalin, Ph.D., Senior Vice President, Aptiv Solutions

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