Overview
The use of statistics in clinical trials insures a valid and robust
study which minimizes bias in assessing the efficacy of new drug
treatment or medical devices.
Participants in this 6 hour virtual
seminar will learn the fundamentals of statistical theory, and how
statistical concepts are applied in analysis and reporting of clinical
research findings.
The objective of the seminar is to provide
information that can be used immediately by personnel involved in
analysis of clinical trial data. Emphasis will be placed on the actual
statistical (a) concepts, (b) application, and (c) interpretation, and
not on mathematical formulas or actual data analysis. A basic
understanding of statistics is desired, but not necessary.
This
seminar also provides a thorough review of the basics for those who need
a refresher on statistical theory and types of statistical analyses.
Learning Objectives
- Statistics
is a useful decision making tool in the clinical research arena. When
working in a field where a p-value can determine the next steps on
development of a drug or procedure, it is imperative that decision
makers understand the theory and application of statistics.
- Many
statistical softwares are now available to professionals. However,
these softwares were developed for statisticians and can often be
daunting to non-statisticians. How do you know if you are pressing the
right key, let alone performing the best test?
- This seminar
provides a non-mathematical introduction to biostatistics and is
designed for non-statisticians. And it will benefit professionals who
must understand and work with study design and interpretation of
findings in a clinical or biotechnology setting.
- The focus of
the seminar is to give you the information and skills necessary to
understand statistical concepts and findings as applies to clinical
research, and to confidently convey the information to others.
Therefore, a basic/fundamental to intermediate understanding of
statistics is all that is needed to understand and apply the information
presented in this webinar.
Who Will Benefit
- Investigators
- Physicians
- Clinical Investigators
- Clinical Research Statisticians
- Clinical Research Coordinators
- Clinical Research Nurse Coordinators
- Clinical Research Associates/Assistants
- Clinical Project Managers/Leaders
- Study Managers
- Regulatory Professionals who use statistical concepts/terminology in reporting
- Medical Writers and others who need to interpret statistical reports
Agenda
Why Statistics?
- Do we really need statistical tests?
- Sample vs. Population
- I'm a statistician not a magician! What statistics can and can't do
- Descriptive statistics and measures of variability
15 minute break
- The many ways of interpretation
- p-values
- Confidence intervals
- Effect sizes
- Clinical vs. meaningful significance
30-minute break
- Common Statistical Tests
- Comparative tests : t-tests, Analysis of Variance (ANOVA)
- Correlation
- Linear Regression analysis
- Non-parametric techniques
15- minute break
- Other Statistical Tests
- Comparing Survival Curves and Cox Regression
- Logistic Regression
Speaker Profile
Elaine Eisenbeisz is a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California. Elaine has over 30 years of experience in creating data and information solutions for industries ranging from governmental agencies and corporations, to start-up companies and individual researchers.
In addition to her technical expertise, Elaine possesses a talent for conveying statistical concepts and results in a way that people can intuitively understand.
Elaine’s love of numbers began in elementary school where she placed in regional and statewide mathematics competitions. She attended University of California, Riverside, as a National Science Foundation scholar, where she earned a B.S. in Statistics. Elaine received her Master’s Certification in Applied Statistics from Texas A&M and continues to learn from her practice. Elaine is a member in good standing with the American Statistical Association as well as many other professional organizations. She is also a member of the Mensa High IQ Society. Omega Statistics holds an A+ rating with the Better Business Bureau.
Elaine has designed the methodology for numerous studies in the clinical, biotech, and health care fields. She designs and analyzes studies as a contract statistician for pharmaceutical and proton therapy research. She also works on nutriceutical and fitness studies. Elaine works as a contract statistician with numerous private researchers, CRO’s and biotech start-ups as well as with larger companies such as Allergan, Nutri-System, and Rio Tinto Minerals.
Not only is Elaine well versed in statistical methodology and analysis, she works well with project teams. Throughout her tenure as a private practice statistician, she has published work with researchers and colleagues in peer-reviewed journals. Please visit the Omega Statistics website at www.OmegaStatistics.com to learn more about Elaine and Omega Statistics.
