University of Delaware – School of Nursing
College of Health Sciences
Course Number &Title: NURS667.010 Clinical Trials
Meeting Day/Time: 4-6pm on Wednesdays in 324 Willard (teleconferencing room)
Faculty Dr. Larry Holmes Jr. (Voice: 302-377-3550); e-mail: holmes@medsci.udel.edu
Course description: This course introduces the principles and methods used in clinical trials.
Credit hours, placement in curriculum: 3 credit elective graduate course
Course Format: Live video on campus
Pre-requisite: Consent of instructor. (Intermediate Biostatistics Course, Advanced
Epidemiologic Methods Course, or Graduate Level Statistics Course highly recommended)
Enrollment: Limited to 24 students. Open to Graduate Nursing and Non nursing majors
Course Objectives: Upon completion of the course, the student will be able to:

Differentiate the basic characteristics of a clinical trial and compare the advantages and
disadvantages of randomized clinical trials to other epidemiological and clinical
investigations.

Develop procedures for carrying out randomization and blinding using randomization
schedules.

Apply appropriate research methods for addressing medical & public health questions and
compare and contrast the use of observational and experimental research designs.

Construct a sample size that adequately meets the power requirement for a clinical trial

Construct the statistical design and data analysis plan section of a clinical trial protocol

Analyze the data collection requirements of a clinical trial.

Explain quality assurance procedures, including data reporting requirements, to be carried
out in a clinical trial

Differentiate between intent-to-treat analysis and treatment analyses; and understand the
advantages of one over the other.

Conduct meta-analysis of clinical trials using original research articles

Perform data analysis using sample data in clinical trial
Teaching tools:
 Video conference
 Lecture
 Data analysis
Recommended Textbooks
 Friedman LM, Furberg CD, DeMets DL. Fundamentals of Clinical Trial, (current edition).
Springer, New York, 1998
 Hulley SB, Cummings SR, Browner WS et al. Designing Clinical Research, (2nd ed.)
Lippincott Williams & Wilkins, Philadelphia, 2001
 Stuart J. Pocock. Clinical Trials. A Practical Approach. John Wiley & Sons, Hoboken,
New Jersey., 2002
Evaluation methods

Two Homework assignments (25%)
a. Critique of the phases of clinical trials with respect to internal validity and
generalizability of findings in improving patient care (10%).
b. Appraisal of three articles in clinical trials - objective (primary secondary
outcomes), design, randomization, blindness, placebo, analysis plan and
statistical technique, conduct, results and interpretation (15%).

Midterm Exam: Take Home test - Critique of CT protocol - randomly assigned CT for
assessment of strengths and weakness with respect to feasibility/environment,
innovation, interest, ethical consideration, clinical relevance (25%)

Final Exam: Development and presentation of a Clinical Trial Proposal for NIH related
funding. Description (abstract), Background, Specific aims & hypothesis, Design &
Plan, Conduct/implementation, Analysis, Expected result, Cited literature, Human
Subjects and Limitations (50%).
Lecture
Topic and Description
Readings & Comments
One
Basic notion of clinical trial (CR) – definition of
trial, types and phases of CR, rationale for
conducting CR
On campus presentation
– chapters 1, 18
Two
Conceptualizing and conducting CR – Protocol
development using NIH template -Developing CR
research question, hypothesis statement and
testing and study variables
NIH criteria for protocol
scoring, chapters 2/3/4
Three
Overview of statistical techniques in data analysis
– one proportion/mean, two proportions/means, >
two proportion/means – t test, ANOVA, linear
regression, correlation, logistic regression,
Proportional Cox Model
PPT lectures, chapter 14
(KM curve, Cox
regression)
Four
Study population and multi-center trials – Definition Chapters 3/7/14
of study population (entry criteria, adequate sample
Assignment # 1 due
size etc.,) sample from population, generalization
and recruitment
Five
Study designs – basic design of clinical research,
types of design used in CRs.
Chapter 4
Six
Clinical trial meta-analysis design/conduct
Mid-term – take home,
due next class.
Assignment #1
Submission of clinical trial
proposal title
Seven
Clinical Trial Conduct – randomization and
blindness
Chapters 5/6
Eight
Sample size estimation and power of study
Software illustration,
chapter 7
Chapter 9
Nine
Recruitment of subjects and baseline assessment
Assignment # 2
Ten
Data collection, safety & monitoring, data-analysis
techniques – sample survival data analysis
exercise
Chapter 10/ 11/ 12
Eleven
Outcome assessment and basic notion of survival
data
Chapters 14/ 15/ 16
Assignment # 2 due
Twelve
Statistical analysis, interpretation of results and
manuscript preparation
Analysis of survival data
using STATA, SPSS),
Chapters 14/ 15/ 16 /18
Thirteen
Final Exam
Proposal presentation –
on campus
Filename: clinical trials proposal 12.18.08