Course "Fundamentals of Statistical Design for Clinical Trials" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
This 2-day seminar includes an overview of the need for clinical research, types of clinical trial designs, common statistical tests, considerations of sample size, and randomization techniques.
The role of statistics in clinical trials incorporates the tools used to develop a robust study, minimize bias, and assess efficacy of new treatments as relates to efficacy and comparison to competing therapies.
Prior to the use of experimental research, clinicians often used subjective measures and anecdotal evidence of treatment efficacy. Concepts such as variability among individuals and treatments were not considered in early applications.
The application of scientific method, which makes use of the tools statistical theory, allows clinical researchers to set up a robust study design and to make precise and accurate inferences from the information collected in a clinical trial. According to Carter, Scheaffer, and Marks (1986), "Statistics is unique among academic disciplines in that statistical though is needed at every stage of virtually all research investigations including planning the study, selecting the sample, managing the data, and interpreting the results."
The objective of the seminar is to provide information that can be used immediately by personnel involved in the design and analysis of clinical trials. Although the presentation involves use of statistical techniques, presentation of statistical theory will be limited to only what is needed by the attendees to understand and implement trial design and end-point analyses within the statistical framework. However, a basic understanding of basic statistical tests (t-tests, ANOVA, regression) is desired.
Presented examples and training will include the design of a simple randomized trial. A template of a statistical analysis plan will be given to all attendees for use in their practice.
Why you should attend:
Clinical trials are expensive, time consuming, and labor-intensive. Many hands are involved in a successful trial including sponsors, investigators, nurses, data management personnel, legal boards, and regulatory agencies. A set of tools to design a study, collect the information, and analyze the results is required to assure a proper framework for a robust study with minimal bias. Statistics is this tool-set.
While there are similarities in the development and execution of clinical trials, each study presents challenges and differences that require forethought and troubleshooting. A well-informed researcher will enhance the process of conducting and analyzing a clinical trial. Researchers have an ethical obligation to the safety of trial subjects and to the proper practice of medicine. Statistical concepts help to assure proper ethics.
The U.S. Food and Drug Administration (FDA) and other regulatory agencies require the minimization of bias in study design and analysis. In order to minimize bias, particular steps and safeguards, using regulatory guidance, must be put into place to assure validity of a research. Regulatory standards require statistics help to ensure that a study is valid, ethical, reproducible, and transparent. A researcher with a good understanding of the elements of statistical design and analysis will strive to be ethical and objective in order to best benefit the patients he or she serves.
Areas Covered in the Session:
- History and reasoning of clinical trials
- Scientific method and hypothesis testing
- FDA, ICH 9 Guidance/references
- Basic clinical trial designs
- Study endpoints and statistical tests
- Randomization of participants
- Sample size considerations
- Design a statistical analysis plan
Owner and Principal Statistician ,
Elaine Eisenbeisz is a private practice consultant based in Southern California. She has over 20 years of experience in creating data and information solutions for industries ranging from governmental agencies and corporations, to start-up companies and individual researchers.
In addition to her technical expertise, Elaine possesses a talent for conveying statistical concepts and results in a way that people can intuitively understand.
Elaine’s love of numbers began in elementary school where she placed in regional and statewide mathematics competitions. She attended University of California, Riverside, as a National Science Foundation Scholar, where she earned a B.S. in Statistics with a minor in Quantitative Management, Accounting. Elaine completed her graduate certification in Applied Statistics with Texas A & M University. Gig ‘em Aggies! Currently, she is finishing her graduate work in Applied Statistics at Rochester Institute of Technology.
Elaine is a member of The American Statistical Association as well as many other professional organizations. She is also a member of the Mensa High IQ Society. Elaine is also a member in good standing with the Better Business Bureau.
Current areas of interest include Bayesian inference, simulation and bootstrapping techniques, and predictive modeling.
When she isn’t crunching numbers you can find Elaine digging in her garden, playing her violin, cooking, or playing board games with friends.
- Trial Sponsors
- Principal Investigators
- Clinical Investigators
- Clinical Research Coordinators
- Clinical Research Nurse Coordinators
- Clinical Research Associates/Assistants
- Clinical Project Managers/Leaders
- Study Managers
- Regulatory Professionals/Coordinators
- Medical Writers who need to interpret statistical reports
The DoubleTree Baltimore-BWI Airport
890 Elkridge Landing Road