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.
