ComplianceOnline

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

Instructor: Robert S Hoop
Product ID: 701382
  • Duration: 60 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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.

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.

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