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 statistical formulas or computations.
- Ascertain what information the statistician needs to determine the sample size
- Choose 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
- Become comfortable talking with statisticians
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
The course will be led by one of the following instructors:
Elkan Halpern, Ph.D.
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Day One: 8:30 a.m. – 5:00 p.m.
- 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: 8:30 a.m. – 5:00 p.m.
- 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
There will be a 15 minute morning break, 1 hour lunch break, and 15 minute afternoon break on each training day.
- Drawing Random Samples
- Constructing Confidence Interval
- Creating and Testing with Real Data Individual and Group Hypotheses
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Elizabeth Andrews at 781-972-5418 to discuss your options and take advantage of the savings.
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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 mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-12-047-L01-P. Released 10/12.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.