Clinical Trials Statistics -Bioavailability and Bioequivalence

Dr. Anil Gore and Dr. Sharayu Paranjpe

Aim of Course:

This course covers the topics of bioequivalence and dose-response modeling, and provides practical work with actual/simulated clinical trial data. After taking this course, participants will be able to specify the design of a new drug or new device study, with the goal of establishing whether the new drug or device is statistically equivalent to an existing therapy. This includes designing the study in accordance with regulatory requirements, as well as appropriate methods for analyzing data. Participants will also be able to fit statistical models to dose-response data, with the goal of quantifying a reliable relationship between drug dosage and average patient response.

Who Should Take This Course:

Analysts responsible for designing, implementing or analyzing 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:

The Instructor:

Dr. Anil Gore is Vice President of Statistical Services at the Pune, India offices 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.

Dr. Sharayu Paranjpe is a Principal Statistician at the Pune, India offices 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.

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:

Aug. 27 - Sep. 24, 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.

Level:

intermediate

Prerequisite:

The equivalent of Introduction to Statistical Issues in Clinical Trials and Clinical Trials Statistics - Pharmacokinetics & Dose.

Course Text:

All necessary course materials will be provided during the course.

Software:

Work in the course will require the use of standard statistical software. Participants can use any of the standard packages they are familiar with (SAS, Minitab, R, SPSS, Stata, etc.) Instructors and/or TA's are familiar with these packages. Instructors will generally use MINITAB and occasionally S+. For more information about obtaining free or nominal cost versions of standard software packages, click here.

Registration:

Register Online - $499
Register Online (academic) - $399 (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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