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Introduction to Statistical Issues in Clinical Trials

Dr. Sharayu Paranjpe and Dr. Anil Gore

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.

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.

For those enrolled in a Program of Advanced Statistical Studies, this is a required or elective course in the following Programs:

  • Biostatistics (controlled trials) - required

Course Program:

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

The Instructor:

Dr. Sharayu Paranjpe is a Principal Statistician at Vislation Inc., a subsidiary of CYTEL, a statistical software and services company based in Boston, MA. Currently she supervises the statistical analyses of about 25 statisticians who work on clinical trials that are conducted in different parts of the world by various multinational pharmaceutical companies. She has over 25 years teaching experience. She is author of ClinStat: Statistical Analysis of Clinical Trial Data(forthcoming), A Course in Mathematical and Statistical Ecology, and has also written or co-written dozens of articles in peer-previewed journals.

Dr. Anil Gore is Vice President of Statistical Services at Vislation Inc, a subsidiary of CYTEL, a statistical software and services company based in Boston, MA. He co-ordinates training, analysis, consulting and research activities in the field of clinical trials. His current work involves modeling patient recruitment in clinical trials. He is co-author of the classic Statistical Analysis of Nonnormal Data, and has also written Numeracy for Everyone(forthcoming) and A Course in Mathematical and Statistical Ecology. Dr. Gore has a special interest in statistical ecology and is the author of several dozen articles in peer-previewed journals.

Organization of the Course:

The course takes place over the internet, at statistics.com. 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. The course is scheduled to take place over 4 weeks, and typically requires 15 hours per week. 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 and work through exercises. Discussion among participants is encouraged. The instructor will provide answers and comments.

Certificates and Grades:

You may be interested only in learning the material presented, and not be concerned with grades or certificates. Or you may be enrolled in a statistics.com Program in Advanced Statistical Studies that requires demonstration of proficiency in the subject, in which case your work will be assessed for purposes of issuing a grade. Or you may require only a "Certificate of Course Completion," along with professional development credit in the form of Continuing Education Units (CEU's). As you begin the class, you will be asked to specify your category.

Credit:

This course offers continuing education units (CEU's). For those successfully completing the course (generally this means marks of 50% or better on the homework), 5.0 CEU's and a certificate will be issued by statistics.com, upon request.

Dates:

Oct. 30 - Nov. 27, 2009
Jun. 25 - Jul. 23, 2010
Click here to be notified of future course offerings.

Participants gain access to the online materials on the first day of the course, and typically spend about 15 hours per week (at their convenience). You retain full access to course materials, including discussion board, for two weeks after the course closing date.

Prerequisite:

The equivalent of Introduction to Statistics 1: Inference for a Single Variable, and Introduction to Statistics 2: Working with Bivariate Data (and, if necessary before these courses, Introduction to Statistics for Beginners or Survey of Statistics for Beginners).

We also recommend our "Biostatistic 1 and 2" and "Survival Analysis" courses as companions, for those interested in getting the most out of this course. See below (Registration) for 3-course tuition package.

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 by clicking here 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.

Registration:

Register Online - $469
Register Online (academic) - $369 (you must be affiliated with a college, university or high school)

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.

Consider registering for this course together with two other Clinical Trials courses as part of our special 3 course package registration for tuition savings.

Note: 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.

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