Applied Clinical Research (POPM*6230) Fall 2015

Transcription

1 Applied Clinical Research (POPM*6230) Fall 20 Coordinator Statistical Consultant Graduate Teaching Assistant Cathy Bauman Olaf Berke Rafael Spurio Rm 2533, Stewart Building Description: This is a 0.5 credit introductory graduate course for veterinary clinicians and clinical researchers on how to design, fund, and analyze clinical research. Observational study designs and studies of medical tests will be explored. Emphasis, however, will be placed upon the design and analysis of clinical trials. Objectives Students who complete this course should be able to: Formulate good clinical research questions. Evaluate the appropriateness of different clinical research designs. Plan a well-designed clinical trial. Analyze the results from clinical trials. Write a well-organized grant proposal. Course Approach Applied Clinical Research is offered in two 80-minute sessions twice per week to allow time for meaningful in-class learning activities to take place. New information will often be introduced through readings done in preparation for the next classroom session. Classroom time will usually be devoted to the application of new information and exploration of its implications. You can expect to take an active role during class sessions in learning activities and small and large group discussion. Classroom activities and assignments will give you experience choosing a clinical research design, critiquing clinical trial designs, preparing to visit and visiting a statistician, choosing the right statistical test, and using the statistical program R to run some statistical tests on data. The major project is to prepare a research grant proposal requesting funding to carry out a clinical or experimental trial to determine if a new intervention (treatment, preventive technique, surgical procedure) is better than no intervention or an older intervention. Preparing a grant proposal will help you to learn how to develop a research idea, put the idea into its proper scientific context, and convince other people that the research is important and should be funded. The skills that you develop in this project should be useful to you in your graduate research program and your future attempts to secure funding for research /09/20

2 Prerequisites There are no specific prerequisites for this course. Your undergraduate statistics course will be helpful. If your research involves observational study designs more than the clinical and experimental trial designs emphasized in this course, you might consider taking Epidemiology I (POPM*6200) and Epidemiology II (POPM*6210) offered by this department. Statistical Software: There are a number of readily available software packages which run most of the statistical tests you will need. We are electing to use R, which is a free software package available on the main OVC hard-drive or to be easily downloaded to your own laptop or computer. Textbooks The following textbooks are recommended for the course and pre-class readings will be derived from some of them. Students can access the list of reserve books as well as links to online reserves via Ares and Courselink. Ares can be accessed at: ). Please note that only reserve items are located at the OVC Learning Commons; all other publications are now housed at the Main Library. Study Design and Clinical Trials: Hulley SB, Cummings SR, Browner WS et al. Designing Clinical Research, 3 rd Edition. Philadelphia: Lippincott, Williams & Wilkins, Holmes M, Cockcroft, P. Handbook of Veterinary Clinical Research. Oxford: Blackwell Publishing Ltd., Friedman LM, Furberg, CD, DeMets, DL. Fundamentals of Clinical Trials, 3 rd ed. New York: SpringerVerlag, Call # R853.C55 F Sackett DL, Haynes RB, Guyatt GH, Tugwell P. Clinical Epidemiology: A Basic Science for Clinical Medicine, 2 nd ed. Toronto: Little, Brown and Company, Call # RA652.C Grant Proposal Writing: Friedland AJ, Folt CL. Writing Successful Science Proposals. 2 nd Edition. New Haven: Yale University Press, Day RA. How To Write & Publish a Scientific Paper, 5 th ed. Phoenix: Oryx Press, Call # T11.D Gilpin AA, Patchet-Golubev P. A Guide to Writing in the Sciences. Toronto: University of Toronto Press, /09/20

3 Statistics Portion: Petrie A and Watson P. Statistics for Veterinary and Animal Science. London: Blackwell Science Ltd., Call # SF760.S73 Norman GR, Streiner DL. Biostatistics: The Bare Essentials, 3 rd ed. BC Decker Inc, Hamilton, Ontario Evaluation and Grading The course is grade will be comprised of points from the following areas: Assignments 30% In-class Quiz 10% Midterm Project 30% Final Exam 30% Total 100% Assignments: 1. 10% - To help with learning during classroom activities, you will be asked at the beginning of classes to submit a brief simple written piece worth 1 mark each. Each submitted piece of preparatory work will be marked on a pass/fail basis. You need to complete at least 8, or you will not get any marks % Analysis of categorical data (Stats half of class) 3. 10% Analysis of continuous data (Stats half of class): Midterm Project: Research Grant Proposal project due before class on Oct 29 th. Courselink: Additional course materials and information regarding all assignments will be posted on the Courselink website. The website can only be accessed by persons who are registered for the class, therefore it is imperative that students ensure that they are registered for the class and have access to courselink. If you have any problems accessing courselink go to or CCS at x58888 or help@uoguelph.ca /09/20

4 Office hours Given the varied schedules for students and course instructors, there are few common times that are well suited for office hours. As such, we will not have formal regular office hours. However, we want you to succeed in the course and we are here to help you do just that. If you want to meet with one of the instructors or the teaching assistant, please take the time to come to see us individually whenever you determine it will help your learning. Contact us by and we will make an appointment to meet with you. Academic Misconduct The University of Guelph is committed to upholding the highest standards of academic integrity and it is the responsibility of all members of the University community faculty, staff, and students to be aware of what constitutes academic misconduct and to do as much as possible to prevent academic offences from occurring. University of Guelph students have the responsibility of abiding by the University's policy on academic misconduct regardless of their location of study; faculty, staff and students have the responsibility of supporting an environment that discourages misconduct. Students need to remain aware that instructors have access to and the right to use electronic and other means of detection. Please note: Whether or not a student intended to commit academic misconduct is not relevant for a finding of guilt. Hurried or careless submission of assignments does not excuse students from responsibility for verifying the academic integrity of their work before submitting it. Students who are in any doubt as to whether an action on their part could be construed as an academic offence should consult with a faculty member or faculty advisor. The Academic Misconduct Policy is detailed in the Graduate Calendar: Important dates (Fall 14) Th Sep 4 First day of class F Sep 12 Add period for fall semester classes ends Fri Oct th class day last day to drop one semester classes Th 27 Last day of class /09/20

5 Dates, Times and Rooms for POPM*6230 Fall 20 Week Day Date Time Room Lecturer Topic 1 2 Tuesday 3 Tuesday 4 Tuesday 5 Tuesday 6 Tuesday 7 Tuesday 10- Course Introduction Evidencebased Medicine EBM and Research Questions Research Questions and Study Designs Levison/Bolinder No class NA NA Study Designs and RCTs RCTs, variables, sample size Sample size and randomization Ethics Approval Randomization and blinding Funding and Budgets Fall study break Mid-term Grant proposals Last class ACR /09/20

6 8 Tuesday 9 Tuesday 10 Tuesday 11 Tuesday 12 Tuesday 13 Tuesday 14 Tuesday Oct 27, 20 Oct 29, 20 3, 20 5, 20 10, 20 12, 20 17, 20 19, 20 24, 20 26, 20 Dec 1, 20 Dec 3, 20 Dec 14, 20 1:00- LLC 1713 Berke Statistics- Introduction Descriptive Statistics Probability and Distributions Sampling and Inference Hypothesis testing Hypothesis testing Correlation and Linear regression Logistic and Poisson Regression Nonparametric methods Statistics - Survival Agreement Review 1714 Berke Final Exam /09/20