Skip to content

Explore Courses | Elder Research | Contact | LMS Login

Statistics.com Logo
  • Courses
    • See All Courses
    • Calendar
    • Intro stats for college credit
    • Faculty
    • Group training
    • Credit & Credentialing
    • Teach With Us
  • Programs/Degrees
    • Certificates
      • Analytics for Data Science
      • Biostatistics
      • Programming For Data Science – Python (Experienced)
      • Programming For Data Science – Python (Novice)
      • Programming For Data Science – R (Experienced)
      • Programming For Data Science – R (Novice)
      • Social Science
    • Undergraduate Degree Programs
    • Graduate Degree Programs
    • Massive Open Online Courses (MOOC)
  • Partnerships
    • Higher Education
    • Enterprise
  • Resources
    • About Us
    • Blog
    • Word Of The Week
    • News and Announcements
    • Newsletter signup
    • Glossary
    • Statistical Symbols
    • FAQs & Knowledge Base
    • Testimonials
    • Test Yourself
Menu
  • Courses
    • See All Courses
    • Calendar
    • Intro stats for college credit
    • Faculty
    • Group training
    • Credit & Credentialing
    • Teach With Us
  • Programs/Degrees
    • Certificates
      • Analytics for Data Science
      • Biostatistics
      • Programming For Data Science – Python (Experienced)
      • Programming For Data Science – Python (Novice)
      • Programming For Data Science – R (Experienced)
      • Programming For Data Science – R (Novice)
      • Social Science
    • Undergraduate Degree Programs
    • Graduate Degree Programs
    • Massive Open Online Courses (MOOC)
  • Partnerships
    • Higher Education
    • Enterprise
  • Resources
    • About Us
    • Blog
    • Word Of The Week
    • News and Announcements
    • Newsletter signup
    • Glossary
    • Statistical Symbols
    • FAQs & Knowledge Base
    • Testimonials
    • Test Yourself
Student Login

Introduction to Statistical Issues in Clinical Trials

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.

This course will teach you the basic statistical principles in the design and analysis of randomized controlled trials.

$799 | Enroll Now
Alert me to upcoming courses
Group Rates
  • Overview
  • Learning Outcomes
  • Instructors
  • Syllabus
  • Dates
  • Prerequisites
  • Student Stories
  • FAQS
  • Requirements
Menu
  • Overview
  • Learning Outcomes
  • Instructors
  • Syllabus
  • Dates
  • Prerequisites
  • Student Stories
  • FAQS
  • Requirements

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 Level Course
4-Week Course
100% Online Courses
Expert Instructors
Teacher Assistant Support
Tution-Back Guarantee

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.

Instructors

Loading...
Dr. Nand Kishore Rawat

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.

See Instructor Bio

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

2023

Jun 9, 2023 to Jul 7, 2023

Nov 24, 2023 to Dec 22, 2023

2024

Jun 14, 2024 to Jul 12, 2024

2025

No classes scheduled at this time.

Send me reminder for next class

Prerequisites

Introductory Statistics

We assume you are versed in statistics or have the equivalent understanding of topics covered in our Statistics 1 and Statistics 2 courses. but do not require them as eligibility to enroll in this course. Please review the course description for each of our introductory statistics courses, estimate which best matches your level of understanding of the material covered in these courses, then take the short assessment test for that course. If you can not answer more than half of the questions correctly, we suggest you take our Statistics 1 and Statistics 2 courses prior to taking this course.

    • For Statistics 1 – Probability and Study Design, take this assessment test.
    • For Statistics 2 – Inference and Association, take this assessment test.
Loading...

What Our Students Say​

Loading...
Left Square Qoute
Stephen McAllister

The material covered here will be indispensable in my work. I can't wait to take other courses. Great work!

Stephen McAllister
Library Planning Consultant at Ottawa Public Library
Right Square Qoute
Left Square Qoute

The instructor was exceptional at answering unclear issues raised and pointing you to right materials to further help your understanding

Oluseun Shittu
West London Mental Health NHS Trust
Right Square Qoute

Frequently Asked Questions

Can I transfer or withdraw from a course?

We have a flexible transfer and withdrawal policy that recognizes circumstances may arise to prevent you from taking a course as planned. You may transfer or withdraw from a course under certain conditions.
  • Students are entitled to a full refund if a course they are registered for is canceled.
  • You can transfer your tuition to another course at any time prior to the course start date or the drop date, however a transfer is not permitted after the drop date.
  • Withdrawals on or after the first day of class are entitled to a percentage refund of tuition.
Please see this page for more information.

Who are the instructors at the Institute?

The Institute has more than 60 instructors who are recruited based on their expertise in various areas in statistics. Our faculty members are:

  • Authors of well-regarded texts in their area;
  • Advisory board members;
  • Senior faculty; and
  • Educators who have made important contributions to the field of statistics or online education in statistics.

The majority of our instructors have more than five years of teaching experience online at the Institute.

Please visit our faculty page for more information on each instructor at The Institute for Statistics Education.

Please see our knowledge center for more information.

What type of courses does the Institute offer?

The Institute offers approximately 80 courses each year. Topics include basic survey courses for novices, a full sequence of introductory statistics courses, bridge courses to more advanced topics. Our courses cover a range of topics including biostatistics, research statistics, data mining, business analytics, survey statistics, and environmental statistics. Please see our course search or knowledge center for more information.

Do your courses have for-credit options?

Our courses have several for-credit options:
  • Continuing education units (CEU)
  • College credit through The American Council on Education (ACE CREDIT)
  • Course credits that are transferable to the INFORMS Certified Analytics Professional (CAP®)
Please see our knowledge center for more information.

Is the Institute for Statistics Education certified?

The Institute for Statistics Education is certified to operate by the State Council of Higher Education for Virginia (SCHEV). For more information visit: https://www.schev.edu/ Please see our knowledge center for more information.

Visit our knowledge base and learn more.

FAQs + Knowledge Base

Related Courses

Loading...
Biostatistics 1 - For Medical Science and Public Health Course

Biostatistics 1 – For Medical Science and Public Health

This course teaches the principal statistical concepts used in medical and health sciences. Basic concepts common to all statistical analysis and of specific importance in medicine and health are covered in detail.
Topic: Statistics, Biostatistics | Skill: Intermediate | Credit Options: ACE, CEU
Class Start Dates: Jul 21, 2023, Jan 5, 2024, Jul 19, 2024
Mapping in R Course

Biostatistics 2 – For Medical Science and Public Health

This course teaches you clinical trial designs including randomized controlled trials, ROC curves, CI and tests for relative risk and odds ratio, and an introduction to survival analysis.
Topic: Statistics, Biostatistics | Skill: Intermediate | Credit Options: ACE, CEU
Class Start Dates: Feb 10, 2023, Aug 25, 2023, Feb 9, 2024
Mapping in R Course

Biostatistics for College Credit

Biostatistics for Credit reviews the procedures covered in the introductory courses Biostatistics 1 and Biostatistics 2, and covers in more detail the principal statistical concepts used in medical and health sciences.
Topic: Statistics, Biostatistics | Skill: Intermediate | Credit Options: ACE, CEU
Class Start Dates: Jul 21, 2023, Jan 5, 2024, Jul 19, 2024, Jan 3, 2025
Mapping in R Course

Clinical Trials – Pharmacokinetics and Bioequivalence

This course will teach you the statistical measurement and analysis methods relevant to the study of pharmacokinetics, dose-response modeling, and bioequivalence. The course provides practical work with actual/simulated clinical trial data.
Topic: Statistics, Biostatistics | Skill: Intermediate | Credit Options: CEU
Class Start Dates: Jul 14, 2023, Jul 12, 2024, Jul 11, 2025

Additional Course 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.

Please order a copy of your course textbook prior to course start date.

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.

Software Uses and Descriptions | Available Free Versions
To learn more about the software used in this course, or how to obtain free versions of software used in our courses, please read our knowledge base article “What software is used in courses?” 

Course Fee & Information

Enrollment
Courses may fill up at any time and registrations are processed in the order in which they are received. Your registration will be confirmed for the first available course date unless you specify otherwise.

Transfers and Withdrawals
We have flexible policies to transfer to another course or withdraw if necessary.

Group Rates
Contact us to get information on group rates.

Discounts
Academic affiliation?  In most courses you are eligible for a discount at checkout.

New to Statistics.com?  Click here for a special introductory discount code.  

Invoice or Purchase Order
Add $50 service fee if you require a prior invoice, or if you need to submit a purchase order or voucher, pay by wire transfer or EFT, or refund and reprocess a prior payment.

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.

Supplemental Information

There is no supplemental content for this course.

Miscellaneous

There is no additional information for this course.

Register for This Course​

Introduction to Statistical Issues in Clinical Trials
$799 | Enroll Now
Get Notified

Have a Question About This Course?

Janet Dobbins

Sales and Business Development

Phone

(571) 281-8817

Send Us A Note

We like to hear from you.

Name*

Email*

Phone

Company

Message*

 

Send

About Statistics.com

Statistics.com offers academic and professional education in statistics, analytics, and data science at beginner, intermediate, and advanced levels of instruction. Statistics.com is a part of Elder Research, a data science consultancy with 25 years of experience in data analytics.

 The Institute for Statistics Education is certified to operate by the State Council of Higher Education for Virginia (SCHEV)

Our Links

  • Contact Us
  • Site Map
  • Explore Courses
  • About Us
  • Management Team
  • Contact Us
  • Site Map
  • Explore Courses
  • About Us
  • Management Team

Social Networks

Facebook Twitter Youtube Linkedin

Contact

The Institute for Statistics Education
2107 Wilson Blvd
Suite 850 
Arlington, VA 22201
(571) 281-8817

ourcourses@statistics.com

  • Contact Us
  • Site Map
  • Explore Courses
  • About Us
  • Management Team

© Copyright 2023 - Statistics.com, LLC | All Rights Reserved | Privacy Policy | Terms of Use

By continuing to use this website, you consent to the use of cookies in accordance with our Cookie Policy.

Accept