Introduction to Statistical Issues in Clinical Trials

Introduction to Statistical Issues in Clinical Trials

led by Nand Kishore Rawat

Aim of Course:

This online course, "Introduction to Statistical Issues in Clinical Trials" covers the basic statistical principles in the design and analysis of randomized controlled trials. Participants will learn the basic principles for the design of trials, and sample size determination. They will also learn the appropriate statistical techniques associated with the major types of end points for trials (categorical, count, Normal, non-Normal). Participants will also be introduced to pharmacokinetics and the study of drug concentration data.

This course may be taken individually (one-off) or as part of a certificate program.
Course Program:

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 - Statistican'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


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.

Introduction to Statistical Issues in Clinical Trials

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.
You should be familiar with introductory statistics.
Organization of the 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 Requirement:
About 15 hours per week, at times of  your choosing.

Options for Credit and Recognition:
Students come to the Institute for a variety of reasons. As you begin the course, you will be asked to specify your category:
  1. No credit - You may be interested only in learning the material presented, and not be concerned with grades or a record of completion.
  2. Certificate - You may be enrolled in PASS (Programs in Analytics and Statistical Studies) that requires demonstration of proficiency in the subject, in which case your work will be assessed for a grade.
  3. CEUs and/or proof of completion - You may require a "Record of Course Completion," along with professional development credit in the form of Continuing Education Units (CEU's).  For those successfully completing the course,  CEU's and a record of course completion will be issued by The Institute, upon request.
  4. Digital Badge - Courses evaluated by the American Council on Education have a digital badge available for successful completion of the course.  
  5. Other options - Specializations, INFORMS CAP recognition, and academic (college) credit are available for some courses
Course Text:

The required text is Fundamentals of Clinical Trials by Friedman, Furberg, and DeMets.

The book is available here


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. For more information about obtaining free or nominal cost versions of standard software packages, click here.



December 06, 2019 to January 10, 2020 June 12, 2020 to July 10, 2020

Introduction to Statistical Issues in Clinical Trials


December 06, 2019 to January 10, 2020 June 12, 2020 to July 10, 2020

Course Fee: $589

Do you meet course prerequisites? What about book & software? (Click here to learn more)

We have flexible policies to transfer to another course, or withdraw if necessary (modest fee applies)

Group rates: Email jdobbins "at" to get information on group rates. 

First time student or academic? Click here for an introductory offer on select courses. Academic affiliation?  You may be eligible for a discount at checkout.

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