Homework 3 Solution Homework 4 Solution
	Dear Bio642 students, Thanks for participating in the 2010 course on Design of Clinical Experiments. You would help us and future students if you would take a few minutes to give feedback about how to improve the course at https://apps3.jhsph.edu/courseevaluations/students/ Thanks in advance for taking a bit of time to share your ideas. All the best, Scott
First Term August 26 - October 19, 2010

LECTURES

3:00 pm - 4:20 pm  Tuesday, Thursday
JHSPH Room W2015

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

e-Register

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
   

• Clarification on Ethics of International Trials
• NYTimes.com: New Drugs Stir Debate on Basic Rules of Clinical Trials
• Course Plan        
• 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/  
       

  • CCT, The Chinese University of Hong Kong (web based):

    • http://www.cct.cuhk.edu.hk/stat/

     

• SurfStat -- on-line statistical tables:

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

• Department of Biostatistics

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Last updated Monday, November 01, 2010
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