The Center for Professional Innovation & Education, Malvern, PA
October 19 - 21, 2009
Who Should Attend
This course is designed as an introduction to the statistical principles that form the basis for the design and analysis of research investigations in pharmaceutical and medical device studies. The focus of topics will benefit individuals within the pharmaceutical, biotech and device industries including medical investigators, basic and clinical research scientists, clinical research associates those involved in regulatory affairs.
The course will concentrate on the philosophy and understanding of the statistical principles required in conducting sound scientific investigations. It will not simply present statistical formulae. Thus, the lectures are oriented toward professionals having little or no formal training in statistics or mathematics.
Those completing this course will have an understanding of the concepts and statistical methods required in biological and health science research. They will be able to interpret results related to design and analysis issues as routinely presented in the scientific literature and clinical trials.
Introductory Methods (2 Days). This part of the course will introduce and detail the basic and intermediate statistical concepts that are essential for professionals in a biological, public health or medical environment. The first day will emphasize the principles of descriptive and inferential statistical applications while the second day will focus on actual study examples, problem solving and interpretation of results. Throughout the course, participants are encouraged to ask questions and discuss examples relevant to their own work. The following include but are not limited to topic areas to be discussed.
- Basic statistical terminology needed to effectively communicate with and understand your statistical colleagues
- The statistical essentials required to initiate a research investigation
- Research questions in statistical terms
- Sample size considerations to insure accuracy of conclusions in clinical trials to determine treatment efficacy
- Discussion of statistical techniques to compare experimental approaches or treatment efficacy
Advanced Topics (3rd Day). This section of the course will go cover more complex issues in research investigations and clinical trials. Topics will include:
- Association studies including correlation and regression analysis with clinical applications
- Examination of Phase I, II and III clinical trials analysis
- Survival analysis and discussion of techniques in bioequivalence and biotherapeutic studies
- Gaining information from multiple studies by meta-analysis