Final Exam  (pdf) Final Exam  (Word doc)      Due Dates: Final Exam due Oct 27 Paper due Nov 2 Assignment:  Course paper

First Termerm August 27 - October 21, 2009

LECTURES

3:00 pm - 4:20 pm  Tuesday, Thursday
JHSPH Room W2008

INSTRUCTORS

LECTURE NOTES:

Copies of lecture materials are distributed during class. Copies of most materials are available for downloading in the "Classes" section of the course web site.

Adobe Acrobat Reader (version 9+) is needed to view materials posted on the website. 

Download Acrobat Reader (version 9+ required)

WEBSITE:

http://biostat.jhsph.edu/courses/bio642

Userid:  (given in class)

Password:  (given in class)

Contains course schedule, office hours, lecture notes, quizzes, solution keys, data sets, and Stata examples

AUDIO:

An audio file of each lecture is available in the "Classes" section of the website 

TEXTBOOK:

Steven Piantadosi.
Clinical Trials: A Methodological Perspective, Second Edition.
Wiley: 2005.

GRADING

Based on problem sets, final examination, and a paper on a topic related to clinical experiments.

e-REGISTER FOR COURSE e-MAIL

To receive course announcements and to receive credit, all students must register an e-Mail address

 

COURSE DESCRIPTION AND LEARNING OBJECTIVES:

Introduces the application of traditional experimental design theory to biomedical control experiments, including event time studies. Stresses methods of bias and variability, particularly randomization, blocking, factorial designs, stratification, and adequate sample size. Emphasizes clinical trials and other types of medical experiments likely to be encountered by biometric researchers. Discusses elements of analysis when they relate to the design principles.

Upon successful completion of this course, students will be able to:

1. Understand basic clinical trial design principles including bias control, random error control, randomization, blocking, and masking;

2. Have a working knowledge of quantitative properties of clinical trials including precision of estimation, power, sample size, and accrual dynamics;

3. Have experience with specific types of designs of practical and historical interest including dose-finding, safety and efficacy, and comparative trials;

4. Understand the importance of design and its relation to the analysis of clinical trials;

5. Demonstrate knowledge of clinical trial methods by discussing specific design and/or analysis problems expertly.

OTHER LINKS:

• Course Information

• Questions and Answers
   

• Resources for Information on Clinical Trials (Table 1.1, Piantadosi text)
  

  • Guide for scientific and ethical review of trials
       (www.assert-statement.org)

  • Cochrane Collaboration - systematic reviews
       (www.cochrane.org)

  • Federal and private clinical research
       (www.clinicaltrials.gov)

  • CONSORT statement
       (www.consort-statement.org)
    

  • Evolution of fair tests of medical treatments
       (www.jameslindlibrary.org)
    

  • Uniform requirements for biomedical manuscripts
       (www.icmje.org)
    

  • Publication of pharmaceutical clinical trials
       (www.gpp-guidelines.org)
    

  • PubMed - 14+ million biomedical articles
       (www.ncbi.nlm.nih.gov/entrez/query.fcgi)
    

  • ICH efficacy guidelines
       (www.ich.org/cache/html/250-272-1.html)
    

  • Current controlled trials
       (www.controlled-trials.com)
    
    

• Free design software:

  • Design software developed by Steven Piantadosi, M.D., Ph.D

  • Download zip file
     

  • Dupont & Plummer at Vanderbilt University (Windows only): 

    • http://biostat.mc.vanderbilt.edu/twiki/bin/view/Main/PowerSampleSize     

    • Download software
       

  • Java program SampleSize.jar from U. Wisconsin
    (works on PCs & Macs)

    • http://www.biostat.wisc.edu/landemets/  
       

• SurfStat -- on-line statistical tables:

  • http://surfstat.anu.edu.au/surfstat-home/tables/normal.php

• Department of Biostatistics

  Home    |    Schedule    |   Classes    |    Problem Sets   |    e-Mail   

Last updated Tuesday, October 20, 2009
©2009, Department of Biostatistics,              Johns Hopkins Bloomberg School of Public Health              All Rights Reserved	http://www.free-counter-plus.com