NAMSA is pleased to announce our 2014 Remote Training Series events. Our topics this year include biostatistics, ISO 10993-12 information, chemical characterization, and study design application for clinical evidence.
Practical Biostatistics for Clinical Trials: How to find and Use Your Biostatistician
Biostatistical support for clinical trials is an oft-misunderstood and challenging topic. This presentation will detail how to go about finding and using your biostatistician as well as providing useful real-world case studies and regulatory interactions, including lessons learned in plain English and without technical verbiage.
Event Date: Wednesday, February 26, 2014 11:30 AM – 12:30 PM (Eastern Time)
Event Cost: $185/registration
About the Speaker:
Scott Brown is Medical Research Scientist with NAMSA Clinical and Consulting. He has 12 years of experience in clinical trials, focusing on biostatistics for medical devices, and has participated in the design, development and analysis of over 25 PMAs and 510(k) submissions including Bayesian analysis and adaptive study designs. He has represented sponsors at several FDA Advisory Panels and is a co-author on 15 manuscripts published in refereed journals, with experience in therapeutic fields including cardiology, neurology, audiology and urology. He holds a Ph.D. in statistics from the University of Minnesota and lives in suburban Minneapolis.
ISO 10993-12 Sample Preparation and Reference Materials
Event Date: March, 19th 2014
Registration information for the ISO 10993-12 Sample Preparation and Reference Materials Remote Training Series Seminar will be made available in February. Please contact us at firstname.lastname@example.org with questions.
Mike Hendershot and Amy Hoffmann
Using Chemical Characterization for Material Equivalency
Event Date: April, 16th 2014
Registration information for the Using Chemical Characterization for Material Equivalency Remote Training Series Seminar will be made available in February. Please contact us at email@example.com with questions.
About the Speaker:
Dr. Darin Kent, Medical Research Toxicologist at NAMSA, holds a BS in biochemistry from San Francisco State University and an MS, and PhD in chemistry from the University of California, San Diego; he is a Diplomate of the American Board of Toxicology. Darin has been working in the medical device toxicology field for over 15 years, developing expertise in the interpretation of biocompatibility and chemical characterization data in the context of the risk assessment of medical devices and materials. Darin has performed risk assessments and developed biological safety evaluation plans for a wide variety of medical devices and materials in support of successful regulatory submissions to the FDA, notified bodies, and a variety of other regulatory agencies.
Meta-Analysis of Medical Device Data: Applications for Study Design and Reinforcing Clinical Evidence
Regulators and payers are increasingly relying on quantitative meta-analysis as an important component of evidence-based decision-making. Meta-analysis is a statistical method for integrating findings from multiple studies to reach a more precise estimate of a treatment effect, resolve disagreement between studies, and identify relationships between characteristics of a study population and the outcome of interest. Its application to combining multiple data sources to increase precision and accuracy of treatment effects is important and well known; however meta-analysis is an under-utilized tool in the design stage that can lead to considerable reductions in the time, cost, and difficulty of a clinical trial. This course will offer an introduction of how systematic reviews and meta-analyses are planned and performed for a scientific or regulatory audience. We will discuss practical examples of how meta-analysis can be used to:
- create a literature-based performance goal in the presence of historical control data to design a single arm-study in lieu of a randomized controlled trial;
- establish a data-driven non-inferiority margin;
- leverage historical data to either reduce sample size in the design stage; and
- aggregate conflicting or disparate study results to reach a consensus. Other extensions such as making indirect treatment comparisons and investigating the impact of study-level characteristics on outcomes will also be discussed.
Event Date: June, 18th 2014
Registration information for the Meta-Analysis of Medical Device Data: Applications for Study Design and Reinforcing Clinical Evidence Remote Training Series Seminar will be made available in February. Please contact us at firstname.lastname@example.org with questions.
About the Speaker:
Chris Miller, Senior Medical Research Biostatistician at NAMSA holds a BA in psychology with a concentration in statistics from St. Olaf College and an MS in biostatistics at the University of Minnesota. Chris has been working in the medical device field for over 5 years supporting FDA pre-IDE, 510(k), PMA, and EU submissions. Chris has developed expertise in the design, analysis, and reporting of clinical trials, statistical analyses for missing data, and meta-analysis. In addition to biostatistical consulting, Chris has co-authored peer-reviewed articles in cardiology, urology, diabetes, surgery, psychology, and genetics journals.
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