That statistics can be a vital decision-making tool for clinical research is well-established. It is helpful for the clinician in situations where a p-value can help determine the next steps in the development of a drug or procedure. It is thus vital for decision makers to comprehend the theory and application of statistics.
We have many statistical software applications that help in arriving at crucial decisions. However, almost all these software applications were developed for statisticians. These software applications could confound the non-statisticians. Their confusion could start with something as basic as even knowing which key to press.
In this scenario, learning how to use biostatistics and derive its benefits is important. A marathon, six-hour webinar being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, on October 25, will explain biostatistics for the non-statistician.
Elaine Eisenbeisz, a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California, will be the expert at this webinar. Please visit https://www.globalcompliancepanel.com/virtual-seminar/6-hour-virtual-seminar-on-biostatistics-for-the-non-statistician-10307LIVE to register for this webinar.
This webinar, designed for non-statisticians, provides a non-mathematical introduction to biostatistics. Elaine will arm the participants with all the information and skills necessary for understanding statistical concepts and findings as they apply to clinical research, and to confidently convey this knowledge to people with whom they work.
This webinar will emphasize statistical concepts, application, and interpretation, and not on mathematical formulas or actual data analysis. Participants are expected to have an elementary understanding of statistics, but this is not mandatory.
It is aimed at professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.
This will be the agenda that will be covered at this webinar:
- 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
The many ways of interpretation
- Confidence intervals
- effect sizes
- Clinical vs. meaningful significance
Common Statistical Tests
- Comparative tests
- Regression analysis
- Non-parametric techniques
- A different way of thinking
- Bayesian methods and statistical significance
- Bayesian applications to diagnostics testing
- Bayesian applications to genetics
Interpreting Statistics – Team Exercise
- Team Exercise: Review a scientific paper and learn how to
- Interpret statistical jargon
- Look for reproducibility, transparency, bias, and limitations
- Convey information coherently to non-statisticians
Study power and sample size
- Review of p-value, significance level, effect size
- Formulas, software, and other resources for computing a sample size
Developing a Statistical Analysis Plan
- Using FDA guidance as a foundation, learn the steps and criteria needed to develop a statistical analysis plan (SAP).
- An SAP template will be given to all attendees.
Specialized topics/Closing Comments/Q&A
- Comparing Survival Curves
- Pharmacokinetics/Pharmacodynamics (PK/PD)
- Taking a holistic view to study design and interpretation
- Question and Answer session.
About the Director:
Elaine brings 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. She has designed the methodology for numerous studies in the clinical, biotech, and health care fields.
She currently is an investigator on approximately 10 proton therapy clinical trials for Proton Collaborative Group, based in Illinois. She also designs and analyzes studies as a contract statistician for nutraceutical and fitness studies with QPS, a CRO based in Delaware.