Introduction to Statistical Issues in Clinical Trials
This course will teach you the basic statistical principles in the design and analysis of randomized controlled trials.
Overview
This course, designed for anyone contemplating a career in the pharmaceutical industry or health research, covers the basic statistical principles in the design and analysis of randomized controlled trials. Students will learn about the role of statistics in clinical trials, how to plan and design experiments, and how to analyze statistical outcomes. You will also be introduced to pharmacokinetics and the study of drug concentration data.
- Introductory
- 4 Weeks
- Expert Instructor
- Tuiton-Back Guarantee
- 100% Online
- TA Support
Learning Outcomes
Students completing this course will learn appropriate statistical techniques associated with the major end points for clinical trials. You will study the domain (what is a clinical trial?), principles of experiment design, and how to develop a statistical analysis plan including trial objectives, hypotheses, and choice of techniques.
- Identify the phases in clinical trials and their scope (new drugs, devices, etc)
- Describe the different possible endpoints for a study (binary, measured data, etc.)
- List the principles of good trial design
- Specify designs for case studies with different endpoints
- Conduct analysis for several different endpoint designs
Who Should Take This Course
Those contemplating a career in the pharmaceutical industry; analysts and scientists at pharmaceutical companies and other health research organizations who want to become involved in the design, monitoring or analysis of clinical trials.
Our Instructors
Dr. Nand Kishore Rawat
Course Syllabus
Week 1
The Domain
- What is a clinical trial?
- Historical remarks, some diseases and discoveries
- Steps(phases)in drug development
- Scope of clinical trials: new drugs, generics, devices, psychiatric therapy, alternative medicine.
- Role of statistics
Week 2
Planning a Clinical Trial – Statistician’s Inputs
- Principles of design of experiments (replication, local control, randomization)
- Power and sample size
- Bias reduction (blinding)
- Commonly used designs
Week 3
Statistical Analysis Plan (SAP) of Clinical Trial
- Trial objectives, hypotheses, choice of techniques, nature of endpoints (illustrated with live cases)
- End point Binary: A Randomizated Evaluation of First-Dollar Coverage for Post-MI Secondary Preventive Therapies (Post-MI FREEE)
- End point – Normal: accuracy study of SoftTouch (a non-invasive device for measurement of peripheral blood biomarkers)
- End point – count data: Pediatric Asthma Alert Intervention for Minority Children With Asthma (PAAL)
- End point – non-Normal: TBTC Study 27/28 PK: Moxifloxacin Pharmacokinetics During TB Treatment
Week 4
Illustrative Statistical Analysis of Clinical Trial Data
- One sample problem – reduction in blood pressure
- Two sample problem – anorexia
- K-sample problem – drowsiness due to antihistamines
- Cochrane’s Q test – allergic response
- Analysis of Time-concentration data in pharmacokinetic study
Class Dates
2022
Instructors:
2023
Instructors:
Instructors:
2024
Instructors:
Prerequisites
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Introduction to Statistical Issues in Clinical Trials
Additional Information
Homework
Homework in this course consists of short answer questions to test concepts.
In addition to assigned readings, this course also has supplemental readings available online, and an end of course data modeling project.
Course Text
The required text is Fundamentals of Clinical Trials by Friedman, Furberg, and DeMets. The book is available here.
Software
No specific software is required.
Any standard statistical software package should be able to handle the illustrations and exercises; SAS is the most widely used software in the field of clinical trials. EXCEL and MINITAB will be used for illustrations during the course. It is possible to download free trial version of MINITAB for 30 days.
Supplemental Information
Literacy, Accessibility, and Dyslexia
At Statistics.com, we aim to provide a learning environment suitable for everyone. To help you get the most out of your learning experience, we have researched and tested several assistance tools. For students with dyslexia, colorblindness, or reading difficulties, we recommend the following web browser add-ons and extensions:
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Register For This Course
Introduction to Statistical Issues in Clinical Trials