Training Overview
Join Elaine Eisenbeisz as she provides an overview of multiple comparisons and why they can be a problem. She will explain the differences between family wise error rate (FWER) and false discovery rate (FDR). Elaine will also present many options for adjusting statistical tests and explain why pre-planning the corrections, if any, for your study is paramount to a robust research study.
Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
Why Should You Attend
A research rarely involves just one single statistical test. And multiple testing can result in statistically significant findings just by chance. After all, with the typical Type I error rate of 5% used in most tests, we are allowing ourselves to “get lucky” 1 in 20 times.
There are a number of ways to control for this chance significance. And as with most things statistical, determining a viable adjustment to control for the chance significance depends on what you are doing. Some approaches are good. Some are not so good. And, sometimes an adjustment isn’t even necessary.
Webinar Takeaway
- Understanding of Type I and Type II error
- When an adjustment for inflated Type I error is appropriate
- When an adjustment for inflated Type I error is not necessary
- Common procedures to control for Type 1 error
- Difference between FWER and FDR
- Overview of FDA Guidance on Multiplicity
Who Will Benefit
- Trial Sponsors
- Physicians
- Clinical Investigator
- Clinical Research Associates
- Clinical Project Managers/Leaders
- Regulatory Professionals who use statistical concepts/terminology in reporting
- Statisticians
- Medical Writers who need to interpret statistical reports
- IRB review board members
- DSMB members
Elaine Eisenbeisz
Statistician ( 30 + yrs exp.)
Owner & Principal of Omega Statistics
Murrieta, California, United States
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.
Our Participants Testimonial
"Elaine is absolutely the best, nicest, easiest to work with and the most fabulous statistician that I have worked with. I cannot say enough about her. I have been in academic medicine for 25 years now and founded a small biotech company. With Elaine's help on data, we were just purchased by Sanofi-Aventis, the 3rd largest pharma company! She helped our company so very much and no question was ever left unanswerable. You are making an excellent choice!"
- Resa Levetan, MD - Co-Founder, Cure DM
"Elaine is a wonderful statistics-oriented resource person who has both technical knowledge and business savvy. Having assisted my needs for a quality statistician, Elaine provided me with a well-planned and timely portfolio to aid in my research. She is very personable, and I highly recommend her impeccable data services."
Cirrelia Thaxton, Ph.D - Education
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About World Compliance Seminars (WCS)
World Compliance Seminars (WCS) is one stop solution for all your pharmaceutical, biotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIH, EMA, as well as numerous European based national regulatory bodies.
These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical Compliance, Process Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.
The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.