Adaptive Designs for Clinical Trials: How to Enhance Your Study's Chances for Success while Saving Time and Money for Your Company

Why Should You Attend:

Adaptive designs for clinical trials have attracted a lot of attention recently because they allow the trialist to start a study with less information than is typically needed for a successful trial. Typically, information about optimal endpoints, effect size, optimal inclusion and exclusion criteria, etc., are gathered from a pilot or feasibility study and used to design the pivotal trial.

Adaptive designs allow these two studies to be combined into a single trial – saving the sponsor company time and money and enhancing the chances for success – with one or more “looks” at the data to adjust the design as necessary. The adjustments can include the sample size, the hypotheses tested, the endpoints evaluated, the patient subgroups included, etc. FDA has been receptive to these designs as they come under pressure to increase the competitiveness of US companies by decreasing time to market.

This webinar will help you identify situations in which adaptive designs would be advantageous and describe the operational and administrative changes to trials under various adaptive designs.

Areas Covered in the Seminar:

• Definition of “adaptive design”.
• Benefits.
• “Legal” adaptations and when to use them.
• Regulatory acceptance.
• Details on how adaptations work.
• Examples.
• Q & A.

Learning objectives:

At the conclusion of this seminar, attendees will be able to:

• Identify situations in which adaptive designs would be advantageous
• List adaptive designs that apply under various situations
• Describe the operational and administrative changes to trials under various adaptive designs

Who Will Benefit:

Companies that develop regulated medical products, such as medical devices, pharmaceuticals, and biologics.

• Clinical Research Professionals
• Clinical Research Organizations
• Regulatory Affairs

Instructor Profile:

Dr. Melissa Martinson, MS PhD, is a founder and President of Technomics Research, LLC. The company, located in the Twin Cities, provides statistical and health economics evaluations of medical technologies and services to the medical device, pharmaceutical, biologics, and managed-care industries in support market approval by FDA and coverage by public and commercial healthcare payers.

Dr. Martinson holds a B.A. in Biology from Swarthmore College, an M.S. in Statistics and a Ph.D. in Health Services Research from the University of Minnesota. She is on the adjunct faculty at the University of Minnesota and St. Cloud State University, where she teaches graduate-level statistics and economic modeling.

Teresa Nelson, MS is a biostatistician with over 15 years experience in the medical device industry in the areas of statistics and health economics. She has extensive experience in study design strategy - analysis of data, interpretation of results and writing of reports for government regulatory bodies and commercial insurers. She has worked on projects in all phases of research from feasibility or pre-market to those supporting market approval and and post-market and outcomes studies. She has FDA panel experience and successfully negotiated many FDA IDE approvals including some recent success with adaptive study designs.

Her experience in health economics includes outcomes studies and cost-effectiveness analyses using healthcare claims analysis and economic modeling. Ms. Nelson has utilized both Bayesian and Frequentist methods in clinical and health economics studies, including Bayesian cost-effectiveness analyses, meta-analysis and evidence synthesis. She has helped many clients determine which methodology is most advantageous for their project, especially from the perspective of the required sample size.

Manya Harsch, MS is a biostatistician at Technomics Research, LLC with over 10 years of experience in the medical device industry. She has worked at major medical device companies with emphasis on cardiac and urological devices. She is an enthusiastic, experienced critical thinker with strong statistical background and solid biological training and understanding of clinical trials. She has extensive experience with pre-IDE, IDE and PMA submissions, Condition of Approval studies, 510K submissions, Japan PMDA submissions and supporting PMDA GCP audits.

Ms. Harsch holds a B.S. in Biology from Utah State University, an M.S. in Zoology and an M.S. in Applied Statistics from North Dakota State University.

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