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Understanding Clinical Research Design to Inform Healthcare - Full Course
This is an introductory course for learners interested in gaining a better understanding of the design and interpretation of clinical research studies. Learners will be introduced to the fundamental concepts used to design clinical studies including how to choose a study design, select a study population, and select an appropriate sample size. Understanding the key elements of clinical research will improve the learners’ ability to read, interpret, and evaluate clinical studies in the medical literature.
All Modules in this Course
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Understanding Clinical Research - 1. The Research Question Module 1 focuses on the first step in designing a clinical study: deciding what question you want to answer. There are many issues to consider when developing a research question to assure that the study results will address your primary area of inquiry. This lesson goes through a step by step process of developing and refining the research question and using it as the foundation for moving forward in the design of a clinical study.
  • 2 Non-Accredited
  • 2 Accreditation Council for Continuing Medical Education
  • 75.00Yes
    Understanding Clinical Research - 2. Study Designs Module 2 describes the differences between a clinical trial, an observational cohort study, and studies that evaluate new medical tests. Strengths and weaknesses of each study design are discussed as well as how to select a study design based on the study aims and available data. Examples from the medical literature are used to demonstrate how the choice of study design impacts study results and conclusions.
  • 5.5 Non-Accredited
  • 5.5 Accreditation Council for Continuing Medical Education
  • 75.00Yes
    Understanding Clinical Research - 3. Subjects and Variables Module 3 discusses how to select the group of people to include in a clinical study that will best address your research question. The key factors to consider in choosing a study population and how the selected population can influence study outcomes and the interpretation of results are described. This module also introduces the concept of predictors and outcomes and how to choose the appropriate measurements for a clinical study.
  • 2.5 Non-Accredited
  • 2.5 Accreditation Council for Continuing Medical Education
  • 75.00Yes
    Understanding Clinical Research - 4. Statistics Module 4 provides an introduction to statistical issues related to clinical studies. Basic statistical principles are reviewed as they relate to reading the medical literature and designing clinical research. How to use and interpret a p-value and what statistical tests are best suited to test study hypotheses are described.
  • 1.5 Non-Accredited
  • 1.5 Accreditation Council for Continuing Medical Education
  • 75.00Yes
    Understanding Clinical Research - 5. Sample Size & Power Selecting the correct number of study participants to test the study hypotheses is a critical step in designing clinical studies. Module 5 presents a concise, step by step approach to selecting sample size and how variations in sample size can influence study outcomes. This module also reviews how to evaluate power calculations in the medical literature and highlights common errors in the interpretation of P values and power calculations in the published clinical studies.
  • 2 Non-Accredited
  • 2 Accreditation Council for Continuing Medical Education
  • 75.00Yes
    Understanding Clinical Research - 6. Enhancing Causal Inference Module 6 addresses common errors in the interpretation of the cause-effect relationship in clinical studies. The concepts of random chance, bias, and confounding as they relate to the design and interpretation of clinical studies are introduced. Strategies are presented to reduce errors and strengthen study conclusions regarding the cause-effect relationship.
  • 2.5 Non-Accredited
  • 2.5 Accreditation Council for Continuing Medical Education
  • 75.00Yes
    Understanding Clinical Research - 7. Questionnaires and Qualitative Research Many clinical studies include qualitative methods to address a wide range of topics including human behavior, psychology, and informed decision-making. In Module 7, basic concepts of qualitative research and common methods for assessment are introduced. The module also focuses on the design of study questionnaires and how to develop questions that are accurate and effectively evaluate the research hypothesis.
  • 1.5 Non-Accredited
  • 1.5 Accreditation Council for Continuing Medical Education
  • 75.00Yes
    Understanding Clinical Research - 8. Data and Safety Monitoring The safety of volunteer participants in a clinical study is of utmost importance. A framework for understanding participant safety in study design and interpretation is introduced in this module. Common methods to evaluate and regulate the safety of study participants including the use of a Data Safety Monitoring Board are discussed, and how data management and quality impacts participant safety is reviewed along with suggestions for procedures to maintain high data standards.
  • 2 Non-Accredited
  • 2 Accreditation Council for Continuing Medical Education
  • 75.00Yes
    Understanding Clinical Research - 9. Ethical Considerations in Research In Module 9 key ethical considerations and regulatory guidance that impact the design and conduct of clinical studies are introduced. Real world examples of current and past clinical studies are incorporated to illustrate key ethical principles among diverse study populations. This module explains the process of informed consent and the role of the Institutional Review Board.
  • 2 Non-Accredited
  • 2 Accreditation Council for Continuing Medical Education
  • 75.00Yes


    Understanding Clinical Research Design to Inform Healthcare


    Course Overview

    This is an introductory course for learners interested in gaining a better understanding of the design and interpretation of clinical research studies. Learners will be introduced to the fundamental concepts used to design clinical studies including how to choose a study design, select a study population, and select an appropriate sample size. Understanding the key elements of clinical research will improve the learners’ ability to read, interpret, and evaluate clinical studies in the medical literature.

    The course is divided into learning modules that review the course content through lectures and reading assignments. Study lectures do not summarize or duplicate reading assignments. Lectures and reading assignments are complementary; learners are encouraged to use both modalities to fully understand the course content. Key learning points are assessed through multiple choice exercises.


    Optional Assignments to Design a Protocol

    For learners interested in designing a clinical study, there are optional exercises that guide one through the process of writing a complete study protocol. The protocol describes all key elements of a study and serves as a road map for conducting the research. In each module, learners will be asked to write one piece of the protocol that is connected to the learning objectives of the lecture and reading assignment. Sample complete protocols are available for reference and review. At the end of the course, learners may use the protocol to implement a clinical study or apply for a funding opportunity.

    Optional Exercises
    Optional exercises provide additional learning opportunities with questions that assess a wide scope of content from the lecture and text. Correct responses are provided with detailed explanations to assist with a deeper understanding of the course content.

    Course Director: Vanessa Jacoby, MD, MAS
    Lecturers
    •    Vanessa Jacoby, MD, MAS
    •    Kirsten Bibbins-Domingo, PhD, MD, MAS    
    •    Alka Kanaya, MD
    •    Thomas B. Newman, MD, MPH
    •    Doug Bauer, MD
    •    Charles E. McCulloch, PhD
    •    Steve R. Cummings, MD
    •    Deborah Grady, MD, MPH
    •    Miriam Kuppermann, PhD, MPH
    •    Alison Huang, MD, MAS
    •    Winston Chiong, MD, PhD

    Textbook  
    All reading for this course is from the textbook Designing Clinical Research, by Dr. Stephen B Hulley, MD MPH, Steven R Cummings, MD, Warren S Browner, MD, MPH, Deborah G Grady, MD, MPH, Thomas B Newman MD, MPH. Lippincott Williams & Wilkins. 4th Edition. 2013. (Note: Kindle version available on Amazon.com.)

    Please note that this textbook can serve as a key resource and reference text for beginning learners and beyond.



    MODULE 1: The Research Question

    Overview: This module focuses on the first step in designing a clinical study: deciding what question you want to answer. There are many issues to consider when developing a research question to assure that the study results will address your primary area of inquiry. This lesson goes through a step by step process of developing and refining the research question and using it as the foundation for moving forward in the design of a clinical study.


    MODULE 2: Study Design

    This module describes the differences between a clinical trial, an observational cohort study, and studies that evaluate new medical tests. Strengths and weaknesses of each study design are discussed as well as how to select a study design based on the study aims and available data.  Examples from the medical literature are used to demonstrate how the choice of study design impacts study results and conclusions.


    MODULE 3: Subjects and Measurements

    This module discusses how to select the group of people to include in a clinical study that will best address your research question. The key factors to consider in choosing a study population and how the selected population can influence study outcomes and the interpretation of results are described.  This module also introduces the concept of predictors and outcomes and how to choose the appropriate measurements for a clinical study.

     

    MODULE 4: Statistics

    This is an introductory module for statistical issues related to clinical studies. Basic statistical principles are reviewed as they relate to reading the medical literature and designing clinical research.  How to use and interpret a P value and what statistical tests are best suited to test study hypotheses are described.

     

    MODULE 5: Sample Size and Power

    Selecting the correct number of study participants to test the study hypotheses is a critical step in designing clinical studies. This module presents a concise, step by step approach to selecting sample size and how variations in sample size can influence study outcomes. This module also reviews how to evaluate  power calculations in the medical literature and highlights common errors in the interpretation of P values and power calculations in the published clinical studies.

     

    MODULE 6: Enhancing Causal Inference

    This module addresses common errors in the interpretation of the cause-effect relationship in clinical studies. The concepts of random chance, bias, and confounding as they relate to the design and interpretation of clinical studies are introduced. Strategies are presented to reduce errors and strengthen study conclusions regarding the cause-effect relationship.

     

    MODULE 7: Questionnaires and Qualitative Research

    Many clinical studies include qualitative methods to address a wide range of topics including human behavior, psychology, and informed decision-making. In this module, basic concepts of qualitative research and common methods for assessment are introduced.  The module also focuses on the design of study questionnaires and how to develop questions that are accurate and effectively evaluate the research hypothesis.

     

    MODULE 8: Data and Safety Monitoring

    The safety of volunteer participants in a clinical study is of utmost importance. A framework for understanding participant safety in study design and interpretation is introduced in this module. Common methods to evaluate and regulate the safety of study participants including the use of a Data Safety Monitoring Board are discussed, and how data management and quality impacts participant safety is reviewed along with suggestions for procedures to maintain high data standards.

     

    MODULE 9: Ethical Considerations in Research

    In this module key ethical considerations and regulatory guidance that impact the design and conduct of clinical studies are introduced. Real world examples of current and past clinical studies are incorporated to illustrate key ethical principles among diverse study populations. This module explains the process of informed consent and the role of the Institutional Review Board.

     


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