Course Description

Designed for non-statisticians, this basic statistical concepts workshop has direct applicability to clinical research. The choice of statistical method, the application of statistical principles, and the interpretation of statistical results are the foundation of the design and analysis of clinical trials. It is therefore critical that statistical methods are fully understood before they are implemented. This course is beneficial to all clinical research professionals involved in the design, monitoring, interpretation, and reporting of clinical trials. Please note that this is not a course on advanced statistical formulas or computations.  An understanding of basic algebra is required as application of some basic statistical formulas will be conducted.

Learning Objectives

• Determine what information the statistician needs to determine the sample size
• Identify the appropriate sample statistical designs for a study
• Employ statistical terms used in clinical research
• Define the role of the statistician in the study design
• Determine the approach to become comfortable talking to statisticians

Who Should Attend

• Monitors who will assist in designing and evaluating studies
• Clinical Research Associates who will be communicating with statisticians
• Clinical Project Leaders who will be designing and evaluating studies
• Regulatory Professionals who utilize statistical concepts in their reports
• Medical Writers who must interpret statistical reports

Instructor

The course will be led by the following instructor:

Misha Eliasziw, Ph.D.

Click here for complete trainer biographies

Course Outline

Day One

• Elements in Choice of Statistical Method Descriptive Statistics: Distributions; mean, median, mode, standard deviation
• Methods for Preserving Objectivity: Blinding; randomization; consequences of violations
• Inference, Generalizing to a Population: Standard error; confidence interval; estimation and prediction
• Study Design: Uncontrolled studies; parallel groups; crossover designs (patient as own control); block designs

Day Two

• Hypothesis Testing: Creating hypothesis from objectives; level of significance, p-values; one-sided versus two-sided; types of errors
• Power and Sample Size: Accuracy of estimates; confidence intervals; testing (effect size and variability)
• Choice of Statistical Method  
• Specialized Topics  
• Interpreting the Statistical Report  

Interactive Activities

• Constructing Confidence Intervals
• Creating and Testing with Real Data Individual and Group Hypotheses
• Calculating Sample Sizes and Study Power

Registration Fees

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-24-007-L99-P. Released: 3/24.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.