Application of Biostatistics in Pharmacy

Course Objectives:
Provides students with an understanding of probability concepts, distributions of
random variables, nonparametric methods, and other statistical methods HSEH in
biousedcal, pharmaceutical, and health care research. Two hours of lecture per
week. Prerequisite !irst professional year standing in the "ollege of Pharmacy
and Health Sciences or consent of the instructor.
Statistics and distributions in samples. Probability theory. Random variables and probability
distributions. Variables, continuous random variables, parameters of probability distributions.
Application of distributions in medicine.
Course Description
This is the Biostatistics core course. Students obtain an understanding of the concepts of
statistical reasoning as applied to the study of clinical pharmacy problems. This includes learning
basic terminology and its meaning, the calculations of various statistical measures and indices,
quantification of health relationships and the interpretation of inferential statistical techniques.

Presents practical sampling methods and their theoretical bacground. !overs simple random,
stratified, systematic, and simple stage cluster sampling techniques" also, ratio, regression, and
difference estimation. #mphasi$es sampling human populations in large communities.
%ntroduces current health problems in biostatistics methods and theory.

At the end of the course the student will be able to: 1) recognize the advantages and
disadvantages of different experimental designs and be able to select the
appropriate design to conduct a study; and 2) properly analyze complex
experiments in public health and practice.

Introduction to Statistical Methods
This course is an introductory applied biostatistical course for students needing a more
comprehensive approach than provided in the !ore !ourse &B%'S ()**+. Topics covered include
probability, confidence intervals, estimation and hypothesis testing. Statistical procedures
covered include t,test, contingency tables, analysis of variance, linear regression and basic
nonparametric procedures.
BIOS! "#$": Introduction to Statistical Methods "
This course constitutes the second part of the basic sequence of applied statistical methods. The
course covers nonparametric methods, multiple linear regression, odds ratios, relative ris,
logistic regression, methods in survival analysis &-aplan,.eier, lifetable analyses, !o/
proportional ha$ards models+, multiple comparisons procedures, the general linear contrast,
multi,0ay A1'VA &general fi/ed effects model, factorial design, qualitative and quantitative
interactions, randomi$ed blocs, random effects models, repeated measures+ and analysis of
covariance.
Introduction to Statistical !heory
Basic introduction to statistical theory. Topics covered include 2oint, marginal and conditional
probabilities" moment generating and characteristic functions" transformation of variables"
convergence of random variables" la0 of large numbers" and the central limit theorem..
Introduction to Statistical !heory "
!ontinuation of the introduction to statistical theory introduced in B%'S ()34. Topics covered
include sufficiency, completeness, Rao,!ramer5s inequality, fundamentals of hypothesis testing,
1eyman,Pearson 6emma, and lielihood ratio tests.
Analysis of Case%Control Studies
Teaches methods to study health problems in community population groups. !overs measures of
disease occurrence and association for various study designs" classical analysis of grouped and
matched case,control studies. Both conditional and unconditional logistic regressions are
covered. .ethods are given for analy$ing a variable number of controls for each case, assessing
the effect of multiple e/pansive levels, and assessing model fit.
Analysis of Cohort Studies
This introductory applied course in statistical modeling focuses on regression methods for the
analysis of cohort data. Topics include the generali$ed linear model and generali$ed estimating
equations &0ith emphasis on logistic and Poisson regression+, and !o/ regression 0ith time,
dependent covariates. Students analy$e several cohort data sets, assess the adequacy of their
models, and interpret their results.
Introduction to Biolo&ical Assay
Teaches statistical techniques in biological assay, including direct and indirect assays,
quantitative and quantal responses, estimation of median effective dose, and comparisons of
effectiveness
Occupational Biostatistics
Topics covered include nested case control studies, design and analysis of historical prospective
studies, the statistical pacage '!.AP, evaluation of disease clusters, and the multistage model.
The course considers the practical problems of e/posure assessment, data collection, and
ad2ustment for confounders in addition to the selection of the appropriate statistical method.
Applied 'e&ression Analysis
!overs the basics of classical and modern regression techniques. Topics covered include
multiple regression, indicator variables, multicolinearity, selection of a best model, influence
diagnostics, and nonlinear regression .
Statistical (stimation !heory
This course covers selected topics in classical estimation and builds on some of the estimation
topics covered in Biostatistics ()33. Topics covered include comparisons of different methods of
estimation, properties of ma/imum lielihood estimations, brief overvie0 of measure theory, and
the decision theoretic frame0or 0or for estimation. Although this course is primarily theoretical
practical issues are discussed such as convergence problems 0hen obtaining ,ma/imum
lielihood estimations, impact of missing data, and the role of some of the recent computationally
intensive methods .
Multivariate Analysis
Topics covered include the multivariate normal distribution, estimation of the mean vector and
covariance matri/, distributions and uses of simple, partial and multiple conclation coefficients,
the generali$ed T( statistic, the distribution of the sample generali$ed variance, multivariate
analysis of variance. .ultivariate methods 0ill be applied to repeated measures analysis, factor
analysis, and discriminant analysis. The beginning of the course emphasi$es theory. 6ater
applications and computational methods are emphasi$ed.
)onparametric Methods in Statistics
'rder statistics and quantiles7 the 8 statistic and 9oeffding5s theorem" rans and mid,rans"
-endall5s and Spearman5s ran correlation coefficients" the sign test" -olmogorov,Smirnov and
!ramer,Von .ises tests of goodness of fit" ran &order+ test" .ann,:hitney &:ilco/on+ ran test"
the several,sample problem" the .ood Bro0n median test" .ood5s median test" the -rusa,:allis
9 test" ;riedman5s test" efficiency of nonparametric tests" Pitman efficiency of tests .
Survival Analysis
!overs the basic theoretical aspects of various models to analy$e <time to event< data. %ntroduces
basic concepts such as the survival function, ha$ard function, left and right hand censoring, and
common parametric models for analy$ing survival data. Also includes the proportional ha$ards
model 0ith fi/ed and time dependent covariates, the stratified P9 model, regression diagnostics
for survival models, additive ha$ards regression models and multivariate survival models.
*i+elihood !heory , Application
he purpose of this course is to introduce the student to modern li!elihood theory and its
applications. he course will cover maximum li!elihood theory" profile li!elihood
theory" pseudo li!elihood theory and generalized estimating e#uations. he course
is taught at the doctoral level and much of the theory is illustrated through
applications.
Clinical !rials: Methods and Practice
$ourse consists of two wee!ly lectures" posted on the web in advance" and two in%class
sessions which consist of #uestions and answers related to the web%based
information" problem%solving" or discussion of case studies. &t covers fundamental
concepts in the design and conduct of modern clinical trials. opics include:
experimental designs for safety and efficacy trials" #uantitative methods for design"
interim monitoring" and analysis of randomized comparative clinical trials including
crossover" factorial and e#uivalence designs. 'thical" organizational" and practical
considerations of design and conduct of single and multicenter studies are
integrated in lectures and case studies. he course also covers international
guidelines on statistical considerations for drug development" guidelines adopted
for publication of trials in ma(or medical (ournals" and recommended approaches for
meta%analyses.
Bayesian and (mpirical Bayes Statistical Methods
Teaches ho0 to use Bayesian and empirical Bayes statistical methods in data analysis. =ives
e/amples and includes discussion of common data,analysis issues. !ompares and contrasts
Bayesian, empirical Bayesian, and classical methods. Topics covered include Savage a/ioms,
con2ugate priors, the lielihood principle, noninformative priors, #mpirical Bayes and hierarchal
Bayes approaches
Bayesian and (mpirical Bayes Statistical Methods
This course provides the students 0ith an understanding of both the theory and practice 0ith
regard to the #. algorithm, .arov,chain, sampling techniques, importance sampling, and the
solution of decision trees. Students gain hands,on e/perience programming 0ith S,Plus. The
course is designed to complement B%'S ()>4 .
Mathematical Methods for Statistics
This course is designed to bridge the gap bet0een students 0ith an undergraduate mathematics
bacground and the mathematics required for the mathematical statistics courses. %t is
recommended for students 0ho meet only the minimum requirement of one year of calculus at
the time of entry into the program. %t covers selected topics in advanced calculus and linear
algebra .
*inear Models
Teaches linear model techniques for analy$ing balanced and unbalanced data. Basic topics
covered include properties of quadratic forms, noncentral chi,square and ; distributions, best
linear unbiased estimations, and lielihood ratio test. Also covers generali$ed inverses, models
not of full ran, orthogonal contrasts 0ith unbalanced data, regression on dummy variables,
analysis of covariance" and analysis of variance components .
Discrete Multivariate Analysis
This more advanced course on modeling multivariate categorical data focuses on the theory and
methods underlying both asymptotic and e/act inference. 6og,linear models, models for ordinal
and multinomial data, e/act logistic regression, and e/tensions of generali$ed linear models to
correlated discrete data are emphasi$ed .
Applied !ime Series Analysis
!overs time series, estimation in the time domain, forecasting, and spectral analysis. Stresses
computer application 0ith real data sets .
Biostatistics Consultin& Practicum
;or second,year master5s and doctoral students. Provides e/posure and e/perience in consulting
on the biostatistical aspects of research problems in biomedical or allied fields. Students have
discussions 0ith investigators, leading to the design or analysis of a current research problem.
%ncludes 0eely group discussions 0ith instructor .
Introduction to Computin&
=ives basic computer sills on the VA?@V.S mainframe. #mphasi$es developing the basics for
data process and analysis using .%1%TAB, an interactive statistical program. Also covers
computeri$ed library searching techniques.
Data Mana&ement and Analysis
#mphasi$es data and file management, and data description aspects of statistical pacages
B.AP, SAS, and SPSS. !overs VA?@V.S system utilities for editing and sorting .
Introduction to Database Mana&ement Systems
=ives database techniques used in a formal database management system. Applications are in
VA?@V.S and P! microcomputer environments .
Applied Statistical Computin& in the -ealth Sciences
Teaches fundamentals of good programming techniques and procedures, strengths and
limitations of computational approaches. %ntegrates programming techniques 0ith biostatistical
and health sciences problems
'esearch and Dissertation for the Doctoral De&ree
Variable number of credits assigned for 0or on student research dissertation.
CLINICAL RESEARCH TRAINING PROGRAM
C*'(S "##.: Computer%based Data Analysis(1 Credit)
Provides instruction on the use of computeri#ed methods for clinical research. $ataset
manipulation, descriptive statistics and the graphical presentation of data will be
presented using a standard statistical package. !o read the syllabus please clic+ here

C*'(S "##: Clinical 'esearch Methods(3 Credits)
Provides an overview of the basic research strategies, methods, and goals of clinical
research. Topics include study design, data analysis and interpretation, and determination
of appropriate methodologies to answer different research questions. Participants will
learn about bias and confounding in observational research, the clinical value of
diagnostic tests, the use of cross%sectional, case%control and cohort study designs, and
various statistical modeling used in clinical research. The course will emphasi#e research
design and measurement. Standard epidemiological measurements &incidence,
prevalence, rates, and risk ratios' will be presented, and tools and techniques to
understand the value of clinical information &(ayes theorem, diagnostic test performance,
and )*" analysis' will be developed.
The design of Phase +, ++, and +++ clinical studies, as well as randomi#ed non%
pharmacological clinical trials will be discussed. "riteria for internal and e,ternal
validity, randomi#ation methods, unbiased outcomes determination, sample si#e
estimation and power calculations will be presented. The implementation of clinical
studies will be presented including recruitment, informed consent, enhancement and
monitoring adherence, and terminating a clinical trial. +ssues in the analysis of clinical
trials, including intention%to%treat and meta analyses will be introduced. !o read the
syllabus please clic+ here

C*'(S "#"#: Biostatistics: Statistical Approaches in Clinical 'esearch (4 Credits)
!ocuses on basic concepts and statistical methods and their application to problems in the
health and biomedical sciences. Topics include data description and summari#ation, basic
probability theory, estimation, and hypothesis testing with emphasis on one% and two%
sample comparisons involving continuous and categorical data. -inear regression and
analysis of variance will be introduced. Students will develop their analytic skills through
the analysis and discussion of large clinical studies.

C*'(S "#": 'e&ression and A)O/A(1 Credit)
$esigned for medical researchers who are non%(iostatistics ma.ors. The course will focus
on the basic concepts of analysis of variance, analysis of covariance, linear regressions
and some useful e,perimental designs. /t the completion of the course, the student
should understand the skills to appropriately use /0*1/ and linear regressions2
develop the skills to appropriately use /0*1/ and3or linear regressions2 understand the
basic concepts behind an e,perimental design for the e,isting medical research2 possibly
build up the ability to design an e,periment for future medical research2 and recogni#e
situations that require more advanced knowledge and methods.

C*'(S "#"": *o&istic 'e&ression(1 Credit)
+ntroductory course in logistic regression modeling. This course is intended for
physicians in fellowship training programs and other researchers with a limited
background in statistics. The course focuses on regression methods for binary data, and
the basics of ma,imum likelihood inference. /t the completion of the course the student
should understand how logistic regression can be used to address a variety of
epidemiological and clinical questions, interpret the models, and assess their
appropriateness and adequacy2 develop analytic skills through the analysis of data sets
taken from the fields of medicine and public health2 and, develop oral and written
communication skills through the description of analytic strategies and the summari#ation
and interpretation of results.

C*'(S "#"0: Co1 'e&ression(1 Credit)
+ntroductory course in regression modeling of time%to%event data. This course is intended
for physicians in fellowship training programs and other researchers with a limited
background in statistics. The course focuses on descriptive methods for survival data,
"o, regression, and the issues pertaining to time%dependent covariates. /t the completion
of the course the student should recogni#e when it is necessary to account for time in the
analysis yes3no outcomes, and appropriately summari#e time%to%event data2 interpret the
"o, regression model, and assess the appropriateness and adequacy of the model2
understand issues in the design, analysis, and interpretation of studies involving time%
dependent covariates2 develop analytic skills through the analysis of data sets taken from
the fields of medicine and public health2 and develop oral and written communication
skills through the description of analytic strategies and the summari#ation and
interpretation of results.

C*'(S "#"$: Applied )onparametric Statistics(1 Credit)
+ntroductory course is intended for physicians in fellowship training programs and other
researchers with a limited background in statistics. This course focuses on statistical
methods that are applicable when research outcomes follow diverse probability
distributions, normal and non%normal. Specific attention will be given to bootstrap and
rank%based methods. Trainees will develop analytic skills through the analysis of data
sets taken from the fields of medicine and public health and develop oral and written
communication skills through the description of analytic strategies and the summari#ation
and interpretation of results.

C*'(S "#$#: Measurement in Clinical 'esearch(1 Credit)
!ocuses on the properties of good measurement integral to the research process. Specific
ob.ectives are to 4' analy#e methods for testing psychometric properties &reliability and
validity' of both psychological and physiological instruments2 5' evaluate the adequacy
of selected scaling methodologies used in research2 6' apply knowledge of
instrumentation in description of a psychosocial and a physiological instrument for a
research proposal2 and 7' synthesi#e course content with statistical criteria for scale
evaluation and make decisions regarding scale revision. The domain sampling model is
presented as the ma.or theory of measurement error with the parallel test model presented
as a special case of domain sampling model. The construct, criterion and content validity
of psychosocial instruments are e,plored and methods for evaluating each of these
relative to specific instruments are presented. / variety of scaling methodologies will be
discussed as well as the principles involved in the design and formatting of
questionnaires. !o read the syllabus please clic+ here

C*'(S "#.#: (thics and 'e&ulation of Clinical 'esearch(1 Credit)
Presents an in%depth e,amination of ethical issues in the conduct of clinical research.
Topics include issues related to privacy, confidentiality, protection of human and animal
sub.ects, and informed consent as well as the role of the +)( in ensuring the responsible
conduct of research. Special consideration will be given to regulatory issues &from *8(,
0+H, +)(, and others' pertaining to the conduct of clinical trials and health service
research. *ther topics will include potential conflicts between research and clinical
priorities2 sub.ect selection2 plagiarism and scientific misconduct2 responsibilities of
sponsors, monitors, and investigators2 research with vulnerable populations2 clinical
equipose2 authorship2 compassionate use of investigational drugs2 orphan drugs2 research
integrity2 and, quality control. The longitudinal component of the ethics module will be
structured to complement the content of the +ntegrated 8ethods Seminar and the
9rantsmanship and (iomedical :riting course. The trainees will use their 0+H style
proposal to create an +nstitutional )eview (oard &+)(' submission. This will be reviewed
and critiqued by the other trainees and selected faculty. (Taken simultaneously with
CLRES 2!" !o read the syllabus please clic+ here

C*'(S "#2#: 'esearch Desi&n and Development Seminar(5 Credits)
The purpose of the integrated methods seminar series is to build upon the skills learned in
the intensive summer session and provide a hands%on research e,perience. Trainees will
learn the phases of the research process from conception, to design, and ultimately,
implementation of the research. Through a combination of group seminars and
independent work, using a topic of their own research choice, trainees will develop their
own research proposal in the form of an 0+H grant application. This will include specific
aims, background and significance, prior work and methods sections. +n addition, trainees
will review and critique the work of their peers. &P#e#e$uisite% Mento# must &e i'enti(ie'
)#io# to *lass+ CLRES 2, is taken simultaneously" !o read the syllabus please clic+
here

C*'(S "#3#: Masters !hesis 'esearch(3 Credits)
Trainees may register for this course with approval from the mentor and selected faculty
of the ")TP "urriculum "ommittee. "-)ES 5;<; is designed for trainees who are
prepared to undertake their substantive research pro.ect or thesis.
%

C*'(S "##: Outcomes and (ffectiveness 'esearch Methods(2 Credits)
Provides a survey of effectiveness research. The curriculum will deal with
conceptuali#ation, design, sampling, modeling, data collection and analysis used in
outcomes and effectiveness studies. The emphasis of the course will be largely on
research methodology and study design. The course will be interactive and will
e,tensively use studies published in the literature as a teaching tool. /t the completion of
the course the student should understand how to design an effectiveness study2 have an
understanding of how to control for severity and comorbidity in the studies of
effectiveness2 know the wide range of outcomes used in this research2 and learn
important e,amples of effectiveness studies. !o read the syllabus please clic+ here

C*'(S "#: 4uality Improvement for -ealth Care(1 Credit)
Provides an introduction to concepts and techniques used to measure and improve the
quality of health care. The causes of the apparent prominence of health care quality in the
current debate about H8*s and managed care will be developed, and an understanding
of the methodologies that can be applied to the process of health care delivery to improve
the quality of care will be presented. The application of the basic techniques used in
quality assessment and process improvement, including statistical process control,
process management and variations analysis will be presented. !o read the syllabus
please clic+ here

C*'(S ""#5-PM """#: Cost%(ffectiveness Analysis(1 Credit)
Provides an introduction to the methods used in the economic analysis of health care
programs. +t will teach the economic principles that provide the foundation of cost%
effectiveness analysis, describe the various methods, ratios and methodologies used in
cost%effectiveness studies, and highlight the current controversies in cost%benefit analysis.
/dditional topics include the appropriate use of cost%effectiveness in making medical
decisions in patients and populations and concepts of perspective, utility analysis,
discounting, and the definition of various costs and benefits. !o read the syllabus please
clic+ here

C*'(S ""5-PM ""2: Clinical Decision Analysis(1 Credit)
Presents an overview of the theory of medical decision-making, the incorporation of
uncertainty and risk into medical decision-making, and describe the use of these
techniques in both population and individual patient settings. The design, structure, and
evaluation of decision tree-using software packages will be presented, and trainees will
become skilled in structuring and analyzing decision problems. Sensitivity analysis and
the stability of model outputs will be presented. Controversies such as perspective of the
analysis, discounting of costs and benefits will be discussed. To read the syllabus please
click here

C*'(S """: Advanced Methods for Decision and Cost%effectiveness Analysis(1
Credit)
E,pands upon topics introduced in "-)ES 545; &"ost Effectiveness /nalysis' and
"-)ES 5454 &"linical $ecision /nalysis' and provides additional guidelines for using
decision sciences in larger, more comple, applications. Topics include modeling clinical
processes and systems2 discrete event simulation2 advanced sensitivity analysis and
confidence limits2 controversies surrounding the use of cost%effectiveness analyses2 and
multi%attribute utility theory. (P#e#e$uisites% CLRES 2-2 an' CLRES 2-2-." !o read
the syllabus please clic+ here

C*'(S"0#: -ealth Services 'esearch 6sin& Secondary Data: A Didactic Course(1
Credit)
Health services researchers and epidemiologists rely on many publicly and privately
available secondary databases, ranging from those collected primarily for research and
surveillance &the 0ational Health +nterview Survey' to those collected for administrative
or billing purposes but which have research utility &8edicare claims'. "-)ES 546;
provides an introduction to many of the large databases that are frequently used by health
services researchers. (P#e#e$uisite (o# CLRES 2-/-"

C*'(S "0: -ealth Services 'esearch 6sin& Secondary Data: Project Course&3
Credit)
Provides students with an opportunity to complete a mentored research pro.ect using one
of theses large secondary databases. *ver a nine%month period of time, Trainees will
revise their research pro.ects from "-)ES 546;, acquire necessary data files to conduct
their study, perform essential data cleaning, manipulation, and analyses, and develop an
abstract for submission to a professional meeting. (P#e#e$uisite% CLRES 2-/"


C*'(S "$#: !he Practice of 'esearch: Project Implementation and Operation(-
C#e'it"
"overs the basic operations of conducting a health services research pro.ect, from
developing realistic timelines and schedules to building tracking databases, training
interviewers and data collectors, monitoring data collection and budgets, to reporting, and
closing out a study.