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CourseBios321Spring2014
(25 Aug 2015,
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---++++ BIOS 321: Clinical trials and experimental design (Spring 2014) ---+++++ For students only * [[CourseBios321Materials2014][Restricted access]] ---+++++ Instructor * [[TatsukiKoyama][Tatsuki Koyama]], !PhD, Associate professor of biostatistics * tatsuki.koyama@vanderbilt.edu; PRB 582; 936.1232 * Office hours: Thursdays 12:30-1:30 Cancer Division office at 2525. ---+++++ Teaching Assistant * [[JoAnnAlvarez][JoAnn Alvarez]], MA, Biostatistician III * Office hours: Tuesdays 3:00-4:00 Cancer Division office at 2525 * joann.alvarez@vanderbilt.edu ---+++++ Schedule * Lectures: Tuesday and Thursday 1:30-3:00, 2525 Conference Room #11105 ---+++++ Course description This course covers the statistical aspects of study designs, monitoring and analysis. Emphasis is on studies of human subjects, i.e. clinical trials. Topics include: principles of measurement, selection of endpoints, bias, masking, randomization and balance, blocking, study designs, sample size projections, study conduct, interim monitoring of accumulating results, flexible and adaptive designs, sequential analysis, analysis principles, adjustment techniques, compliance, data and safety monitoring boards (DSMB), Institutional Review Boards (IRB), the ethics of animal and human subject experimentation, history of clinical trials, and the Belmont report. ---+++++ Prerequisite [[CourseBios6311][Bios 311]] or equivalent<br> [[CourseBios301][Bios 301]] or equivalent (familiarity with R)<br>Familiarity with R: If you did not take Bios 301, check with the instructor. ---+++++ Textbook and other recommended materials Required book: ''Clinical trials: a methodologic perspective (2nd ed)'' by Piantadosi S<br>Recommended book: ''Fundamentals of clinical trials (4th ed)'' by Friedman LM, Furberg CD, <nop>DeMets</nop> DL ---+++++ Assignments There will be homework assignments throughout the semester. You are welcome to discuss the homework assignments with classmates, but you need to submit homework individually. ---+++++ Grading * Homework and project (and class participation): 30% * Midterm Exam (Take home): 35% * Final Exam (Take home): 35% The final exam will focus on the post-midterm materials, however, key concepts covered before the midterm may (almost surely) also appear. ---+++++ *Tentative* schedule %EDITTABLE{ format="|text, 4 |text, 4|text, 10|text, 10|textarea, 3x30|textarea, 3x30 | textarea, 3x35 | "}% | *Week* | *Session* | *Date* | *Topic* | *Reading (PS)* | *Other reading* | *Homework/Exam* | | 1 | 1 | 1/7 (Tu) | Experimental studies and observational studies | | | | | | 2 | 1/9 (Th) | Clinical trial terminologies and clinical trial phases | 2.1 - 2.2, 6.1 - 6.3 | | | | 2 | 3 | 1/14 (Tu) | Topics in hypothesis testing | 5.1 - 5.2 | | | | | 4 | 1/16 (Th) | Bayesian approaches | 5.3 - 5.6 | | | | 3 | 5 | 1/21 (Tu) | _schedule adjustment_ | | | | | | 6 | 1/23 (Th) | Randomization and masking/blinding | 13.1 - 13.9 | | | | 4 | 7 | 1/28 (Tu) | Randomization in clinical trials | | | | | | 8 | 1/30 (Th) | Sample size and power 1 | 11.1 - 11.5 | | | | 5 | 9 | 2/4 (Tu) | Sample size and power 2 | 11.6 - 11.7 | | | | | 10 | 2/6 (Th) | Phase I clinical trials 1 | 10.1 - 10.3 | | | | 6 | 11 | 2/11 (Tu) | Phase I clinical trials 2 | 10.4 - 10.7 | | | | | 12 | 2/13 (Th) | ECMO and TGN1412 | | | | | 7 | - | 2/18 (Tu) | No class _Brad Calin short course_ | | | | | | 13 | 2/20 (Th) | Phase II clinical trial | | | _Midterm exam_ due 2/25 | | 8 | 14 | 2/25 (Tu) | Guest | Ben Saville, <nop>PhD</nop> | | | | | 15 | 2/27 (Th) | | | | | | 9 | - | 3/4 (Tu) | No class _Spring break_ | | | | | | - | 3/6 (Th) | No class _Spring break_ | | | | | | | | Schedule adjustment | Topics: Phase III clinical trials (group sequential and adaptive designs); Meta-analysis; IRB; Misconduct and fraud; | | | | 10 | 16 | 3/11 (Tu) | Phase II clinical trial | | | | | | 17 | 3/13 (Th) | Phase III clinical trial | | | | | 11 | 18 | 3/18 (Tu) | Group Sequential Designs | | | | | | - | 3/20 (Th) | No class | | | | | 12 | 19 | 3/25 (Tu) | Phase III clinical trial | | | | | | 20 | 3/27 (Th) | Phase III clinical trials | | | | | 13 | 21 | 4/1 (Tu) | Factorial designs | 19.1 - 19.7 | | | | | 22 | 4/3 (Th) | Guest | Rafe Donahue, <nop>PhD</nop> | | | | 14 | 23 | 4/6 (Tu) | Factorial designs | | | | | | 24 | 4/10 (Th) | Crossover designs | 20.1 - 20.5 | | | | 15 | 25 | 4/15 (Tu) | Crossover designs | | | | | | 26 | 4/17 (Th) | Fraud and Misconduct | | | _Final exam_ due 4/22 | | 16 | 27 | 4/22 (Tu) | | | | | <!-- | | 28 | 4/24 (Th) | | | | | --> -- Main.TatsukiKoyama - 06 Jan 2013
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Topic revision: r12 - 25 Aug 2015,
RobertGreevy
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