Introduction to Statistical Issues in Clinical 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
Dr. Nand Kishore Rawat is a Portfolio Director of Clinical Research Services at Cytel Statistical Software & Services. With his expertise in planning, designing and analysing clinical trial projects, and his experience in clinical trial development at Bristol-Myers Squibb, Novartis, and also noted contract research organizations (CRO’s), he brings a valuable practical perspective to the classroom and gives his students an insightful window into the pharmaceutical clinical trial world. Dr. Nand Kishore Rawat has expertise in planning, designing and analysing clinical trial projects.
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
2025
Instructors: Dr. Nand Kishore Rawat
Instructors:
Prerequisites
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Additional Information
Organization of Course
This course takes place online at The Institute for 4 weeks. During each course week, you participate at times of your own choosing – there are no set times when you must be online. Course participants will be given access to a private discussion board. In class discussions led by the instructor, you can post questions, seek clarification, and interact with your fellow students and the instructor.
At the beginning of each week, you receive the relevant material, in addition to answers to exercises from the previous session. During the week, you are expected to go over the course materials, work through exercises, and submit answers. Discussion among participants is encouraged. The instructor will provide answers and comments, and at the end of the week, you will receive individual feedback on your homework answers.
Time Requirements
This is a 4-week course requiring 10-15 hours per week of review and study, at times of your choosing.
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.
Course Fee & Information
Enrollment
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Transfers and Withdrawals
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Options for Credit and Recognition
This course is eligible for the following credit and recognition options:
No Credit
You may take this course without pursuing credit or a record of completion.
Mastery or Certificate Program Credit
If you are enrolled in mastery or certificate program that requires demonstration of proficiency in this subject, your course work may be assessed for a grade.
CEUs and Proof of Completion
If you require a “Record of Course Completion” along with professional development credit in the form of Continuing Education Units (CEU’s), upon successfully completing the course, CEU’s and a record of course completion will be issued by The Institute upon your request.
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