This pharmaceutical and medical device training course begins with a brief introductory discussion that will introduce and outline the types of clinical investigations conducted. This includes Phase II (non- randomized and randomized) and Phase III randomized clinical trials. It will emphasize the principles of clinical investigations and the issues to be addressed in the remainder of the course. Also the concept of the p-value and power will be reviewed.
Statistical topics will include, but are not limited to:
- Multiple primary and secondary endpoints in clinical trials and the techniques for addressing the multiple testing procedures that have been proposed
- Missing data in clinical trials, the types of missing data that can arise and the issues involved for handling and interpreting the results from lack of data
- Adaptive designs in clinical studies when an interim analysis indicates a possible midway correction in study design to preserve the integrity of the study
- Addressing the problems of assessing risks in time to event studies when failure may be from competing causes. The course will cover more complex issues in research investigations and clinical trials.
- Introduction to Bayes Analysis in Clinical Studies and their comparison to the traditional hypothesis testing procedures
- Propensity scoring in the presence of many covariates and the advantages of this technique in many clinical studies
- Statistical approaches to high density data involving genetic markers as diagnostic or treatment correlates
- Brief introduction to gaining more information from meta-analysis using meta-regression and other techniques
Who Should Attend
This two-day course is designed as an overview to the statistical principles that go beyond the basics 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 medical device industries including medical investigators, basic and clinical research scientists, clinical research associates those involved in regulatory affairs who have taken the introductory course “Biostatistics for Non–Statisticians” or are familiar with the basic conduct of clinical trials and wish to pursue a deeper understanding of statistical principles.
This biotech training program will concentrate on the philosophy and understanding of the statistical requirements used in conducting sound scientific investigations. It will not simply present statistical formulae. Thus, the lectures are oriented toward professional who have familiarity with basic principles of Biostatistics and/or Statistical Analysis or at least have attended the basic course “Biostatistics for Non-Statisticians".
Those completing this course will have an understanding of the concepts and statistical methods required in pharmaceutical, biological, medical device and other health science research. They will be able to interpret results related to design and analysis issues of modern statistical techniques as routinely presented in the scientific literature and clinical trials. Course participants will be introduced to topic definitions followed by a discussion of their impact on clinical studies and the procedures for handling them in context, with many specific examples used.