CERTaIN: Pragmatic Clinical Trials and Healthcare Delivery Evaluations from edX

In this course, experts will discuss the options a researcher must consider when embarking on clinical research. What research design should I choose? How do I start the process of getting my research approved? How will I analyze the data I collect? These are all important questions that a researcher faces.

We will discuss the key decisions a researcher needs to make when preparing for and conducting research, as well as tools for data analysis. You will learn what a pragmatic clinical trial is and how to calculate power and sample size for your study. You will also be exposed to more complex study designs sometimes used in pragmatic clinical trials, such as Bayesian and adaptive designs.

This course includes the following 11 lectures:

Overview of Design Options for Pragmatic Clinical Trials
Outcome Measures in Clinical Trials
Non-inferiority Trials
Basic Analytic Methods
Basic Power and Sample Size Calculations
SMART: Adaptive Treatment Strategies
Introduction to Bayesian Methods
Bayesian Designs
Quasi-Experiment in Health Services Research
Adaptive Trial Design
Logistics of Clinical Trials

This course is intended for anyone interested in comparative effectiveness research (CER) and patient-centered outcomes research (PCOR) methods.

This course is supported by grant number R25HS023214 from the Agency for Healthcare Research and Quality.

What's inside

Learning objectives

Describepragmatic clinical trial designs
Identify and classify clinical trial designs

Describe the statistical methods used to analyze pragmatic clinical trial data

Describepragmatic clinical trial designs
Identify and classify clinical trial designs
Describe the statistical methods used to analyze pragmatic clinical trial data

Syllabus

Overview of Design Options for Pragmatic Clinical Trials

Types of trial designs including randomized clinical trials

Sources of errors that could lead to erroneous trial results

Outcome Measures in Clinical Trials

Measuring health status and disease

Characteristics of a good outcome measure

Types of outcome measures in clinical trials

Non-inferiority Trials

Non-inferiority trial designs and how they differ from other designs

Interpretation and reporting of results

Basic Analytic Methods

Matching research questions with statistical analysis methods

Interpreting results

Distinguishing intent to treat from per protocol analyses

Problems with missing data

Basic Power and Sample Size Calculations

Relevant issues to estimate sample size in clinical trials

Interpreting study power

Calculating sample size using online calculators

SMART: Adaptive Treatment Strategies

Research questions which can benefit from an adaptive design

Analytic methods for adaptive designs

Interpreting results of adaptive designs

Introduction to Bayesian Methods

Statistical inference

Comparison of frequentist and Bayesian approaches and inference

Bayesian Designs

Bayesian method and adaptive design introduction

Adaptive randomization and predictive probability

Bayesian design trial interpretation

Software tools for conducting Bayesian designs

Quasi-Experiment in Health Services Research

Need for quasi-experiments and their limitations

Difference-in-Differences (DID) estimators and models

Adaptive Trial Design

Limitations of randomized traditional trials

Common adaptive approaches and their challenges

Covariate and outcome adaptive randomization

Logistics of Clinical Trials

Assessing impact, feasibility and funding

Scientific review process

Study initiation, continuing review and audits

Working with sponsors

Good to know

Know what's good

, what to watch for

, and possible dealbreakers

Develops skills and methodologies for the design and execution of pragmatic clinical trials, which are relevant in both industry and academia

Taught by leading experts with a strong reputation in clinical trial design

Offers certification upon completion, attesting to participants' knowledge and skills in pragmatic clinical trial methodology

Provides hands-on examples and case studies to reinforce learning and demonstrate practical applications of the taught principles

Covers a comprehensive range of topics essential for pragmatic clinical trial design, including outcome measures, non-inferiority trials, and adaptive designs

Activities

Be better prepared before your course. Deepen your understanding during and after it. Supplement your coursework and achieve mastery of the topics covered in CERTaIN: Pragmatic Clinical Trials and Healthcare Delivery Evaluations with these activities:

Review 'Introduction to Clinical Trials' by Michael J. Campbell

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Reviewing this book will provide a strong foundation for understanding the fundamentals of clinical trials, which will be essential for success in this course.

View Statistics at Square One on Amazon

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Read the book
Take notes on key concepts
Summarize the main points of each chapter

Volunteer at a clinical research organization

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Volunteering will give you hands-on experience in the clinical research process and allow you to contribute to important research studies.

Browse courses on Clinical Research

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Find a clinical research organization that is looking for volunteers
Apply to volunteer
Complete the required training

Discuss a clinical trial design with a peer

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Discussing your ideas with a peer will help you to refine your thinking and identify any potential flaws in your design.

Browse courses on Clinical Trial Design

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Find a peer who is also taking this course
Schedule a time to meet
Discuss your clinical trial design

Six other activities

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Calculate sample size and power for a clinical trial

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Practicing these calculations will ensure that you have a solid understanding of this essential aspect of clinical trial design.

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Find an online sample size calculator
Enter the relevant parameters
Interpret the results

Develop a data analysis plan for a clinical trial

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Creating a data analysis plan will help you to ensure that your data is analyzed in a rigorous and systematic way.

Browse courses on Data Analysis

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Identify the research questions that you will be addressing
Choose the appropriate statistical methods
Develop a plan for data cleaning and management

Develop a research question for a pragmatic clinical trial

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This activity will help you develop the critical thinking skills necessary to design and conduct a successful clinical trial.

Browse courses on Research Question

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Identify a clinical problem or issue
Formulate a specific, measurable, achievable, relevant, and time-bound question
Write a research proposal

Learn about Bayesian statistics for clinical trials

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Bayesian statistics is becoming increasingly popular in clinical trials, and this tutorial will provide you with the basics of this powerful approach.

Browse courses on Bayesian Statistics

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Find a tutorial on Bayesian statistics
Follow the tutorial
Apply your new knowledge to a clinical trial design

Attend a workshop on clinical trial design

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Attending a workshop will provide you with the opportunity to learn from experts in the field and network with other professionals.

Browse courses on Clinical Trial Design

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Find a workshop that is relevant to your interests
Register for the workshop
Attend the workshop

Contribute to an open-source clinical trial software project

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Contributing to an open-source project will give you practical experience in clinical trial software development.

Browse courses on Open Source

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Find an open-source clinical trial software project
Identify an area where you can contribute
Make a contribution

Career center

Learners who complete CERTaIN: Pragmatic Clinical Trials and Healthcare Delivery Evaluations will develop knowledge and skills that may be useful to these careers:

Epidemiologist

Epidemiologists investigate the causes and patterns of disease in populations. They design and conduct studies to identify risk factors for disease, and they develop and evaluate public health interventions to prevent and control disease. This course can help epidemiologists gain a better understanding of pragmatic clinical trial design and data analysis. The course can help epidemiologists develop the skills they need to design and conduct pragmatic clinical trials and other population-based health research studies.

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Statistician

Statisticians use statistical methods to analyze data and draw conclusions from it. They work in a variety of fields, including medicine, science, and business. This course can help Statisticians gain a better understanding of pragmatic clinical trial design and data analysis. The course can help Statisticians develop the skills they need to design and analyze pragmatic clinical trials and other research studies.

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Biostatistician

Biostatisticians use statistical methods to design, analyze, and interpret data from clinical trials and other health research studies. They work with researchers to develop study designs, collect and analyze data, and draw conclusions from the results. This course can help biostatisticians gain a better understanding of pragmatic clinical trial design and data analysis. The course can help biostatisticians develop the skills they need to design and analyze pragmatic clinical trials and other health research studies.

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Health Economist

Health economists use economic principles to analyze the costs and benefits of health care interventions. They work with policymakers and other stakeholders to develop and evaluate health care policies and programs. This course can help health economists gain a better understanding of pragmatic clinical trial design and data analysis. The course can help health economists develop the skills they need to design and analyze pragmatic clinical trials and other health economics studies.

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Clinical Research Associate

Clinical Research Associates (CRAs) manage clinical trials, ensuring that they are conducted according to Good Clinical Practice (GCP) guidelines. They work with investigators, study coordinators, and other members of the research team to ensure that the trial is conducted safely and efficiently. This course can help CRAs gain a better understanding of pragmatic clinical trial design and data analysis. The course can help CRAs develop the skills they need to effectively manage clinical trials and ensure that the data collected is accurate and reliable.

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Research Scientist

Research Scientists conduct research to develop new knowledge about the world around us. They work in a variety of fields, including medicine, science, and engineering. This course may be useful for Research Scientists who want to gain a better understanding of pragmatic clinical trial design and data analysis. The course can help Research Scientists develop the skills they need to design and conduct pragmatic clinical trials and other research studies.

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Medical Science Liaison

Medical Science Liaisons (MSLs) serve as a link between pharmaceutical companies and healthcare providers. They provide medical information about new and existing products, conduct clinical trials, and help develop educational programs for healthcare professionals. This course may be useful for MSLs who want to gain a better understanding of pragmatic clinical trial design and data analysis. The course can help MSLs develop the skills they need to effectively communicate clinical trial results to healthcare providers and patients.

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Physician Assistant

Physician Assistants (PAs) are licensed healthcare professionals who work under the supervision of physicians. They provide a variety of medical services, including diagnosing and treating illnesses, prescribing medications, and performing minor surgeries. This course may be useful for PAs who want to gain a better understanding of pragmatic clinical trial design and data analysis. The course can help PAs develop the skills they need to evaluate the effectiveness and safety of treatments and to provide evidence-based care to patients.

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Pharmacist

Pharmacists dispense medications and provide advice on their use. They also work with physicians and other healthcare professionals to develop and implement medication therapy plans for patients. This course may be useful for pharmacists who want to gain a better understanding of pragmatic clinical trial design and data analysis. The course can help pharmacists develop the skills they need to evaluate the effectiveness and safety of medications and to counsel patients on their use.

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Veterinarian

Veterinarians diagnose and treat diseases in animals. They also work with animal owners to develop and implement preventive care plans. This course may be useful for Veterinarians who want to gain a better understanding of pragmatic clinical trial design and data analysis. The course can help Veterinarians develop the skills they need to design and conduct pragmatic clinical trials and other research studies to improve the health of animals.

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Registered Nurse

Registered Nurses (RNs) provide a variety of nursing care to patients in hospitals, clinics, and other healthcare settings. They work with physicians and other healthcare professionals to develop and implement care plans for patients. This course may be useful for RNs who want to gain a better understanding of pragmatic clinical trial design and data analysis. The course can help RNs develop the skills they need to evaluate the effectiveness and safety of nursing interventions and to provide evidence-based care to patients.

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Medical Writer

Medical writers develop and write a variety of materials for the healthcare industry, including clinical trial protocols, patient education materials, and marketing materials. They work with medical experts to ensure that the information they produce is accurate and up-to-date. This course may be useful for medical writers who want to gain a better understanding of pragmatic clinical trial design and data analysis. The course can help medical writers develop the skills they need to write clear and concise medical documents.

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Teacher

Teachers plan and deliver instruction to students in a variety of settings, including schools, colleges, and universities. They work with students to develop their knowledge and skills in a variety of subjects. This course may be useful for Teachers who want to gain a better understanding of pragmatic clinical trial design and data analysis. The course can help Teachers develop the skills they need to teach students about clinical research and to evaluate the effectiveness of teaching interventions.

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Science Writer

Science Writers develop and write a variety of materials for the public, including articles, books, and website content. They work with scientists and other experts to ensure that the information they produce is accurate and up-to-date. This course may be useful for Science Writers who want to gain a better understanding of pragmatic clinical trial design and data analysis. The course can help Science Writers develop the skills they need to write clear and concise science-based articles and other materials.

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Technical Writer

Technical Writers develop and write a variety of technical documents, including user manuals, training materials, and marketing materials. They work with subject matter experts to ensure that the information they produce is accurate and up-to-date. This course may be useful for Technical Writers who want to gain a better understanding of pragmatic clinical trial design and data analysis. The course can help Technical Writers develop the skills they need to write clear and concise technical documents about clinical research.

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