(Course #MED26054)
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. Please note that this textbook can serve as a key resource and reference text for beginning learners and beyond.
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.
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.
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
MODULE 5: Sample Size and Power
MODULE 6: Enhancing Causal Inference
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.
