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Adaptive Trial Design for Phase 1 Dose-Finding Studies

Greater flexibility, efficiency and quicker dissemination of research findings to patient communities that stand to benefit are all potential advantages of adaptive trial design as compared to more conventional methods such as 3+3. Novel adaptive approaches are particularly relevant with respect to dose finding and dose optimization in early Oncology development.

In this webinar, we’ll focus on the use of adaptive design approaches in Oncology phase 1 dose-finding studies. For context, our presenters will discuss the evolution of early Oncology development, persistent challenges and recent initiatives, such the FDA’s Project Optimus, that strive to balance efficacy, efficiency and ethical concerns in the pursuit of bringing promising new therapies to patients. Several case studies will be presented to illustrate the value adaptive approaches offer in terms of sample size re-estimation, determining the maximum tolerable dose for future trials, terminating study arms early based on interim results, and enabling more rapid decisions without sacrificing validity.

The webinar examines adaptive design from a multi-disciplinary perspective by incorporating clinical development, modeling and biostatistics. In the webinar’s final section, our presenters explore the interplay between statistical analysis and planned adaptations, trial assumptions and restrictions.

By watching this on-demand webinar, you will learn:

    1. Advantages of adaptive trial design approaches as compared to conventional methods in Phase 1 Oncology dose finding studies

    1. How novel adaptive approaches enable more rapid decisions in practice through a series of case studies

    1. Considerations for a statistical analysis plan and the importance of sustained statistical support to account for planned study modifications

Speakers

Fran Brown, PhD, SVP
Drug Development Solutions

Dr. Fran Brown is a highly respected professional with proven leadership skills and 28 years of broad experience within pharmaceutical development and due diligence. She has extensive experience with strategic and operational global drug development from early discovery to filing and post-marketing. This experience spans multiple therapeutic areas, small molecules and biologics, global regulatory requirements, and registration pathways. She possesses a broad knowledge of product development and portfolio management, with a special focus on development strategy, regulatory interactions and product filings.

Her past appointments include leadership roles within large Pharma as well as in small biotech organizations including head of clinical pharmacology, clinical leader, project development leader, head of clinical operations and due diligence asset assessment. She has over 10 years of experience in providing consulting advice to the pharmaceutical industry and non-profit Global Health Organizations ranging from individual project support to strategic TA strategy and development planning, portfolio management and corporate transformation. She joined Certara in 2017 and is currently the SVP of Drug Development Science within Integrated Drug Development.

Blaire Osborn, PhD
Senior Director, Clinical Pharmacology and Translational Medicine, Integrated Drug Development

Dr. Osborn has over 25 years of drug development experience in the areas of clinical pharmacology and pharmacokinetics. She has focused primarily oncology and anti-infectives. Before joining Certara, she was a reviewer in the Office of Clinical Pharmacology, US FDA, in the Division of Cancer Pharmacology, CDER where, she participated in the assessment of multiple dose justification submissions under Project Optimus. Prior to working in the FDA, she was a clinical pharmacologist in the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institute of Health (NIH). There, projects were focused on therapeutics and vaccines in the infectious disease area. She worked on design and support of phase 1 trials, bioanalytical assay development and validation, and projects using the “Animal Rule” to support development of countermeasures in situations where clinical trials were not ethical or feasible. Dr. Osborn has held roles supporting both clinical and nonclinical pharmacology drug development for large molecules in biotechnology companies including Human Genome Sciences and CoGenesys. She is particularly interested in early phase drug development, including dose selection and justification strategies to speed development of therapeutics.

Dr. Osborn is holds a Ph.D. in Pharmacology from The George Washington University and is based in the Washington DC metropolitan area.

Alex Dmitrienko, PhD
Founder and President, Mediana

Dr. Dmitrienko has been involved in clinical trial statistics for over 25 years and, prior to founding Mediana, worked at Quintiles (Vice President, Innovation Unit) and at Lilly (Research Advisor, Advanced Analytics). He has been actively involved in biostatistical research and has published over 100 papers on key topics in clinical trial statistics, including adaptive designs, multiple comparisons and subgroup analysis. Dr. Dmitrienko has served as an Associate Editor for The American Statistician, Biometrics and Statistics in Medicine, and is a Fellow of the American Statistical Association.

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