Consulting

The Role of Adaptive Trial Designs in Early Oncology Studies: Optimizing Flexibility and Agility

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 place emphasis on 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.

What You Will Learn

  • Challenges inherent to early phase oncology clinical trials
  • Factors to consider in design of early phase oncology studies
  • Adaptive designs for assessing early/late-onset toxicity
  • How adaptive trial designs help optimize efficiency while minimizing the number of patients treated at sub-therapeutic doses

Speakers

Abie Ekangaki, PhD
Vice President, Statistical Consulting
Premier Research

Abie Ekangaki is responsible for providing strategic planning, coordination, knowledge, and expertise in biostatistics for projects and/or standalone consultative services for both internal and external clients. He supports the Business Development and Operations efforts for key customers to design and manage effective and efficient clinical trials/programs bringing specific statistical, drug development, and operational knowledge in the respective area of focus.

With more than 20 years of experience as a biostatistician, Dr. Ekangaki has worked as a research scientist with the World Health Organization in Switzerland, as a statistics lecturer at Macquarie University in Australia, and has held several technical and senior leadership positions in the pharmaceutical industry. Given his more than 17 years in the pharmaceutical industry. He is experienced at applying and advising on the statistical design and analysis of clinical trials in various therapeutic areas, from proof of concept and beyond.

Dr. Ekangaki received his PhD in statistics from the University of Southampton, UK.

Peter Larson, MD
Executive Medical Director
Premier Research

Peter Larson, MD, is Executive Medical Director for Hematology-Oncology. Dr. Larson supports the drug development work of the innovative biotech companies that comprise most of Premier Research’s customer base, bringing to the role over 20 years of clinical development and medical affairs experience. He has a background spanning large pharma, startup biotech, and contract research.

Dr. Larson’s therapeutic expertise includes hematology, oncology, transfusion and cellular therapies, hereditary coagulation disorders, AML, ALL, multiple myeloma, solid tumors, and virology. Product platform experience includes small molecules, biological products including monoclonal antibodies, cellular therapies, and gene transfer technologies. Prior to joining industry he was assistant professor of pediatrics at the University of Pennsylvania. He holds a Doctor of Medicine and a bachelor’s degree in biology from the University of North Carolina and has trained in internal medicine, transfusion medicine/blood banking.