12112 (v.2) Clinical Research Methods 584

Area:

School of Public Health

Credits:

25.0

Contact Hours:

4.0

Lecture:

1 x 2 Hours Weekly

Tutorial:

1 x 1 Hours Weekly

Laboratory:

1 x 1 Hours Weekly

Prerequisite(s):

    13152 (v.2) Health Research Methods 681 or any previous version
    OR
    11547 (v.2) Epidemiology 781 or any previous version
    OR
    13554 (v.2) Epidemiology and Biostatistics 782 or any previous version

Syllabus:

Epidemiology, Clinical trials, randomised controlled trials, quasi-experimental designs for clinical research, single case experimental designs, cohort studies, case-control studies, reliability and validity, inference and interpretation. Multivariate statistical methods including multiple and logistic regression, analysis of variance models and survival analysis. Use of SPSS.

Unit Outcomes:

On successful completion of this unit students will be able to - Develop a conceptual framework for studying and applying study designs used in clinical research methods. Apply epidemiological principles within a clinical research setting. Demonstrate an understanding of the ethical issues related to clinical research. Be able to understand, interpret and conduct descriptive and inferential statistical analyses appropriate for clinical research and to use computerised statistical analyses to that end. Critically appraise examples from the literature relevant to the student's field of study. Be able to design, conduct and analyse a clinical study.

Text and references listed above are for your information only and current as of September 30, 2003. Please check with the unit coordinator for up-to-date information.

Unit References:

Afifi A.A. and Clark V., (1996), Computer-aided Multivariate Analysis, 3rd ed., Chapman and Hall. Altman D.G., (1991), Practical Statistics for Medical Research, Chapman and Hall. Armitage P. and Berry G., (1994), Statistical Methods in Medical Research,3rd ed., Blackwell. Elwood J.M., (1998), Critical Appraisal of Epidemiological Studies and Clinical Trials, 2nd ed., Oxford University Press. Fletcher R.H., Fletcher S.W. and Wagner E.H., (1996), Clinical Epidemiology - The Essentials, 3rd ed., Lippincott. Huck S.W. and Cormier W.H. (1996), Reading Statistics and Research, 2nd ed., Harper and Collins. Jenkins S., Price C.J. and Straker L., (1998), The Researching Therapist, Churchill Livingston. National Health and Medical Research Council 1996, NationalStatement on Ethical Conduct in Research Involving Humans, NH and MRC. Portney L.G. and Watkins M.P., (1993), Foundations of Clinical Research - Applications to Practice, Appleton and Lange. Tabachnick B.G. and Fiddell L.S., (1996), Using Multivariate Statistics, Harper Collins.

Unit Texts:

Hulley S.B. and Cummings S.R., (2001), Designing Clinical Research - An Epidemiologic Approach, 2nd ed., Williams and Wilkins. Gordis L., (1996), Epidemiology, WB Saunders Company. Dawson B. and Trapp R.G., (2001), Basic and Clinical Biostatistics, 3rd ed., Appleton and Lange. In addition for external students - SPSS for Windows statistical software package, Version 10 or 11 (The Student version is sufficient.) [Version 11 requires Windows XP.]

Unit Assessment Breakdown:

Assignments (3) 40%, Final Examination 60%. This is by grade/mark assessment.

Year	Location	Period	Internal	Area External	Central External
2004	Bentley Campus	Semester 2			Y