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Clinical Statistics for Non-Statisticians. An Introduction to Statistical Concepts and Practices-Webinar

Webinars - Clinical Statistics for Non-Statisticians. An Introduction to Statistical Concepts and Practices-Webinar
Webinars

By : Compliance Online

Date : 2012

Location : California / Palo Alto

Video 58m
Description :

In this Clinical Statistics webinar/training all topics will be taught from a practical, non-theoretical perspective for non-statisticians & value and meaning of descriptive statistics including the use of normal vs. non-normal statistics.

Keywords :

clinical statistics, prescription mediation, medical device, NDA, BLA, MAA

Product/ documentation details
Clinical Statistics for Non-Statisticians

Product Type : On Demand Webinar

Author : Robert S Hoop

Video 58m

Languages : English

 

Description 
Professional statisticians have taken 30-50 graduate hours of coursework in order to understand the theory and practice of statistics. And it is a language and thought process that does not come easily to most normal folks. Therefore statistics presents none-too-simple challenges for non-statisticians. Yet the concepts and practice of statistics represent an essential building block for deciding if a prescription medication or medical device is effective and safe, as required by governmental regulations throughout the world.
 
Tasks in which a professional statistician ought to be involved in the clinical process include the following: developing clinical plans, designing studies, protocol review and writing, writing statistical analysis plans, the analysis and interpretation of data, writing and reviewing the clinical study report, planning an NDA/BLA/MAA, and negotiating with regulatory bodies. Thus it is imperative that enhanced communications be developed in order for non-statisticians and statisticians to work together to create and implement high quality science to improve patients' lives.
 
Areas Covered in the seminar:
 
All topics will be taught from a practical, non-theoretical perspective for non-statisticians.
Clinical protocol development: sample size and power, randomization, blinding, prospective/retrospective, and bias.
P-value -- what it really means. Issue of multiple p-values and too many tests.
What is a confidence interval?
The value and meaning of descriptive statistics including the use of normal vs. non-normal statistics.
Continuous vs. categorical data. Within vs. between treatment analyses.
T-tests, ANOVA, ANCOVA, nonparametric tests, CMH, and survival analyses.
Two treatments vs. 3 or more treatments.
Categorical analyses for 2 categories and for >2 categories.
The danger of knowing just a little about statistics.
 
Who will benefit:
 
Professionals who will benefit from this webnar include:
CRAs
Clinical research physicians
Medical writers
Medical editors
Regulatory specialists
SAS programers
Project managers
Pharm D's
 
 

 

Instructor Profile:
Robert S Hoop, MPH, is the owner and president of Robert S Hoop, Inc., a pharmaceutical consulting corporation in the San Francisco Bay Area. Hoop has specialized in the pharmaceutical clinical trial business since 1982 having previously worked for 3 international pharmaceutical companies and one international CRO. He has authored 6 peer-reviewed manuscripts and made presentations at 10 professional conferences. He has expertise in a vast array of therapeutic areas and in Phase 1-4 clinical trials. Hoop has been given multiple awards for the quality of his oral presentations.
Clinical Statistics for Non-Statisticians

Product Type : On Demand Webinar

Author : Robert S Hoop

Video 58m

Languages : English

Organizer : Compliance Online

ComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria