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Introduction to Statistical Issues in Clinical Trials

Instructor(s):

Dates:

December 12, 2014 to January 16, 2015 June 19, 2015 to July 17, 2015 December 11, 2015 to January 08, 2016 June 17, 2016 to July 15, 2016 December 09, 2016 to January 06, 2017 June 16, 2017 to July 14, 2017 December 08, 2017 to January 05, 2018

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Introduction to Statistical Issues in Clinical Trials

taught by Vidaydhar Phadke

Aim of Course:

This course 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:

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

Instructor(s):

Dates:
December 12, 2014 to January 16, 2015 June 19, 2015 to July 17, 2015 December 11, 2015 to January 08, 2016 June 17, 2016 to July 15, 2016 December 09, 2016 to January 06, 2017 June 16, 2017 to July 14, 2017 December 08, 2017 to January 05, 2018

Course Fee: $629

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

Tuition Savings:  When you register online for 3 or more courses, $200 is automatically deducted from the total tuition. (This offer cannot be combined and is only applicable to courses of 3 weeks or longer.)

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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. Please use this printed registration form, for these and other special orders.

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.

Introduction to Statistical Issues in Clinical Trials

taught by Vidaydhar Phadke

Who Should Take This Course:

Analysts and statisticians at pharmaceutical companies and other health research organizations who need or want to become involved in the design, monitoring or analysis of clinical trials.

Level:

Prerequisite:
These are listed for your benefit so you can determine for yourself, whether you have the needed background, whether from taking the listed courses, or by other experience.

We recommend our Biostatistics 1, Biostatistics 2 and Survival Analysis courses as companions, for those interested in getting the most out of this course.

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.


Credit:
Students come to the Institute for a variety of reasons. As you begin the course, you will be asked to specify your category:
  1. You may be interested only in learning the material presented, and not be concerned with grades or a record of completion.
  2. 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. 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, 5.0 CEU's and a record of course completion will be issued by The Institute, upon request.

Course Text:

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

You may order this text directly from the publisher at a discounted price, and using the promotional code, AECT15 (this code is case-sensitive), during checkout time. PLEASE ORDER YOUR COPY IN TIME FOR THE COURSE STARTING 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. For more information about obtaining free or nominal cost versions of standard software packages, click here.


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