MD ID 6370

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Course Details

Course: MD ID 6370 - Clinical Research Basics

Description: The course will explain the basic principles for design of randomized clinical trials and how they should be reported. In the first part of the course, students will be introduced to terminology used in clinical trials and the several common designs used for clinical trials, such as parallel and cross-over designs. We will also explain some of the mechanics of clinical trials, like randomization and blinding of treatment. In the second half of the course, we will explain how clinical trials are analyzed and interpreted. Finally, we will review the essential ethical consideration involved in conducting experiments on people.

Understanding the Clinical Research: Behind the Statistics

If you've ever skipped over the results section of a medical paper because terms like "confidence interval" or "p-value" go over your head, then you're in the right place. You may be a clinical practitioner reading research articles to keep up-to-date with developments in your field or a medical student wondering how to approach your own research. Greater confidence in understanding statistical analysis and the results can benefit both working professionals and those undertaking research themselves.

If you are simply interested in properly understanding the published literature or if you are embarking on conducting your own research, this course is your first step. It offers an easy entry into interpreting common statistical concepts without getting into nitty-gritty mathematical formulae. To be able to interpret and understand these concepts is the best way to start your journey into the world of clinical literature. That's where this course comes in - so let's get started!

Introduction to Systematic Review and Meta-Analysis

We will introduce methods to perform systematic reviews and meta-analysis of clinical trials. We will cover how to formulate an answerable research question, define inclusion and exclusion criteria, search for the evidence, extract data, assess the risk of bias in clinical trials, and perform a meta-analysis.

Design and Interpretation of Clinical Trials:

Clinical trials are experiments designed to evaluate new interventions to prevent or treat disease in humans. The interventions evaluated can be drugs, devices (e.g., hearing aid), surgeries, behavioral interventions (e.g., smoking cessation program), community health programs (e.g. cancer screening programs) or health delivery systems (e.g., special care units for hospital admissions). We consider clinical trials experiments because the investigators rather than the patients or their doctors select the treatment the patients receive. Results from randomized clinical trials are usually considered the highest level of evidence for determining whether a treatment is effective because trials incorporates features to ensure that evaluation of the benefits and risks of treatments are objective and unbiased. The FDA requires that drugs or biologics (e.g., vaccines) are shown to be effective in clinical trials before they can be sold in the US.

Department: Medicine, Interdepartmental

Credit Range: 1 - 1

Permission Required: No

School Years: MSIMSIIMSIIIMSIV

Course Classifications: ELECTIVEVIRTUAL

Coordinator(s): Shear,Shaun DC | u0660505@utah.edu

Directors(s): CHOW,CANDACE (DD) | candace.chow@utah.edu

Possible Grade(s): Fail (F)Incomplete (I)Pass (P)

Prerequisites: None

Add Policy: Course may be added to schedule 30 days before it starts.

Drop Policy: Course may be dropped from schedule 30 days before it starts.

Academic Years

	Title	Year	Tags	#Sec
	MD ID 6370 - Clinical Research Basics	2019/2020	VIRTUALELECTIVE	2