Wednesday, 28 May 2014

Introduction to Statistical Issues in Clinical Trials

Streptomycin has a storied history, and many uses - it is the treatment of choice for plague, and is also used to control algae in ponds.  Its place in statistics history, though, dates to 1946, when a study demonstrated its effectiveness in cases of tuberculosis.  This study - controlled, double blind with a placebo - is generally regarded as the first randomized controlled trial (RCT).  Learn the principles of designing and analyzing RCT's in our online course, "Introduction to Statistical Issues in Clinical Trials," with Dr. Vidyadhar Phadke at For more details please visit

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.

Who can 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.

Course Program:

Course outline: The course is structured as follows
SESSION 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

SESSION 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

SESSION 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

SESSION 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.

Dr. Vidyadhar Phadke is Senior Statistician at Cytel Statistical Software and Services, the leading contract research organization for advanced design of clinical trials.  Dr. Phadke has responsibility for Cytel's industry-leading software for adaptive trials (EaSt) and dose-ranging trials (Compass).

You will be able to ask questions and exchange comments with the instructors via a private discussion board throughout the course.   The courses take place online at in a series of 4 weekly lessons and assignments, and require about 15 hours/week.  Participate at your own convenience; there are no set times when you must be online. You have the flexibility to work a bit every day, if that is your preference, or concentrate your work in just a couple of days.

We, the Center for eLearning and Training (C-eLT), Pune, partner with and offer these courses to Indian participants at special prices payable in INR.

For India Registration and pricing, please visit us at

Call: 020 6680 0300 / 322


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