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.

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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.

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)
  • 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

Dr-Nand-Kishore-Rawat

Dr. Nand Kishore Rawat

Dr. Nand Kishore Rawat is a lead biostatistician 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

2019

Dec 7, 2019 to Jan 10, 2020

2020

Jun 12, 2020 to Jul 10, 2020

Dec 4, 2020 to Jan 8, 2021

2021

No classes scheduled at this time.

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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.

What Our Students Say​

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

Stephen McAllister
Ottawa Public Library

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

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: http://www.schev.edu

Please see our knowledge center for more information.

Visit our knowledge base and learn more.

FAQs + Knowledge Base

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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.

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Introduction to Statistical Issues in Clinical Trials
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