303065 (v.3) Clinical Research Methods 782

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Area:	School of Public Health
Credits:	25.0
Contact Hours:	4.0
Lecture:	1 x 3 Hours Weekly
Tutorial:	1 x 1 Hours Weekly
Prerequisite(s):	11547 (v.2) Epidemiology 781 or any previous version AND 13554 (v.2) Epidemiology and Biostatistics 782 or any previous version
Syllabus:	Overview of clinical research designs including randomised controlled trials, repeated measures, crossover, n of 1 trials, case controls and cohort study designs. Evaluation of diagnostic tests. Critical appraisal. Issues of data management, collection and storage. Research ethics. 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 - Identify basic epidemiological and clinical research concepts found in the literature. Demonstrate a conceptual framework of clinical research, its principles and techniques. Identify, apply and critique analytical techniques appropriate in the clinical setting. Discuss the ethical issues that apply in clinical research. Demonstrate the ability to critically appraise clinical research. Be able to design, present and defend a research grant proposal.
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 (2) 60%, Final Examination 40%. This is by grade/mark assessment.
Year Location Period Internal Area External Central External 2004 Bentley Campus Semester 2     Y