Research Topics
Sub-topics to consider
Summary of literature search including any available
guidelines (FDA, ICH, PhARMA)
Summarize core topic
o Definitions
o Statistical Issues
o Etc
Software/tools
o Create dummy data if need be to help with explainin
Null hypothesis of interest
Average pop treatment means are equal
Cell means model
Main Effects Model
H0
p=0.02
p=0.01
p=0.56
p=0.44
Average pop center means are equal
H0:
STAT 585 Biostatistics II Spring 2015
Instructor:
Office:
Tel No:
Class Time:
Location:
Office Hrs:
Email:
Homepage:
Dr. Mani Lakshminarayanan
Monday, 6:40 9:30 PM
SEC Room 202 BUS
hour before class, by phone (all time), email,
Other times (by appointmen
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PROC GLM is used to conduct an ANCOVA using treatment group TRT and
study center CENTER as variables in the CLASS statement. AGE and
baseline diastolic blood pressure (BPD1A0) are used as numeric covariates
by including them in the MODEL statement but omi
Exercises in Sample Size Determination
1)
2)
3)
Suppose investigators wish to detect the difference between the proportion of
successes of p1=0.4 and p2=0.55, using equal treatment groups with
two-sided) and =0.10. How large must the trial be? Suppose the
Homework ANCOVA
The experimental anti-hypertensive agent, GB2995, was studied in a 4 study centers to
compare 12 weeks of treatment using GB2995 as a sole therapy vs using GB2995 in
combination with a stable dose of a marketed calcium channel blocker when
The six features of effective presentations: a rubric
(guidance)
Heres a (rough) rubric that may be used (by your fellow students) to evaluate your research
presentation
Focus/Content
Whats the point of this presentation? What primary information (researc
Date and Version No:
Insert
Information on Clinical Trial Protocol Template
This protocol template has been designed primarily for Clinical Trials which are subject to the
Medicines for Human use (Clinical Trials) Regulations 2004 and Amendment 2006. It h
Pop Quiz #2
STAT 585
Consider a clinical Trial on The efficacy of a newly developed drug for TreaTing
paTienTs wiTh migraine headaches (Wang and Chow, 1995). The clinical Trial is a
double-blind Three-arm parallel randomized sTudy comparing The newly deve
Appendix
C
STATISTICAL TABLES
Volume II, Appendix C: page 1
Normal Distribution
Table C-1. Cumulative Probabilities of the Standard Normal Distribution.
Volume II, Appendix C: page 2
Chi-Square Distribution
2
Table C-2. Percentiles of the Distribution
Vol
XX STATISTICAL ANALYSIS PLAN
This section outlines the statistical analysis strategy and procedures for the study. If, after
the study has begun, but prior to any unblinding, changes are made to primary and/or key
secondary hypotheses, or the statistical
Statistical Analysis Plan
Protocol C0[xxx]T[xx]
[Protocol Title]
[Acronym]
[if applicable]
Date: 28 August 2015 [type in hard date = date of first signature]
The information in this document contains trade secrets and commercial information that are privi
Exercise in Randomization:
Patients are to be randomly assigned to active and placebo treatments in the ratio 3:2.
to ensure 'balance' a block size of 5 is to be used. Construct a randomization list for a
total sample size of 30.
There are 10 (=5!/3!2!) b
Name:
Pop Quiz #1
STAT 585
1. Which of the following is true of the null and alternative hypotheses?
a) Exactly one hypothesis must be true
b) both hypotheses must be true
c) It is possible for both hypotheses to be true
d) It is possible for neither hypo