This course is part of CERTaIN: Mastering Comparative Effectiveness Research.
This comprehensive course addresses essential considerations for researchers conducting pragmatic clinical trials and healthcare delivery evaluations. Through 11 detailed lectures, participants learn how to make critical decisions when designing, implementing, and analyzing clinical research in real-world settings. The curriculum begins with an overview of design options for pragmatic clinical trials, exploring various trial designs and potential sources of error. Subsequent lectures examine outcome measurement in clinical trials, non-inferiority trial designs, and basic analytic methods for interpreting research results. The course provides practical guidance on power and sample size calculations, including the use of online calculators to determine appropriate study parameters. Advanced topics include innovative research methodologies such as Sequential Multiple Assignment Randomized Trials (SMART) for adaptive treatment strategies, Bayesian approaches to clinical trials, quasi-experimental designs in health services research, and adaptive trial designs that overcome limitations of traditional randomized trials. The final lecture addresses the logistics of conducting clinical trials, including feasibility assessment, the scientific review process, regulatory requirements, and working effectively with sponsors. Throughout the course, participants gain insights into matching research questions with appropriate statistical analysis methods, interpreting results accurately, and addressing common challenges such as missing data and protocol deviations.
Instructors:
English
English
What you'll learn
Design appropriate pragmatic clinical trials for specific research questions
Select and implement suitable outcome measures for clinical research
Apply statistical methods to analyze clinical trial data effectively
Calculate power and sample size requirements for various study designs
Differentiate between frequentist and Bayesian approaches to clinical trials
Implement adaptive treatment strategies using SMART designs
Skills you'll gain
This course includes:
PreRecorded video
Graded assignments, exams
Access on Mobile, Tablet, Desktop
Limited Access access
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There are 11 modules in this course
This course provides a comprehensive introduction to pragmatic clinical trials and healthcare delivery evaluation methods through 11 specialized lectures. Beginning with an overview of design options, the course explores various trial designs, sources of error, and key considerations for research planning. Participants learn about selecting appropriate outcome measures, including different approaches to measuring health status and disease, and the characteristics that define good outcome measures. The curriculum covers non-inferiority trial designs and their unique applications compared to other research approaches. A significant portion of the course focuses on statistical methods, including matching research questions with appropriate analytical techniques, interpreting results, distinguishing between intent-to-treat and per-protocol analyses, and addressing missing data challenges. Practical skills development includes power and sample size calculations using online tools. Advanced topics explore innovative methodologies such as Sequential Multiple Assignment Randomized Trials (SMART) for adaptive treatment strategies, Bayesian approaches to clinical trial design, quasi-experimental methods in health services research, and various adaptive trial designs. The course concludes with a comprehensive examination of the logistics involved in clinical trials, from assessing feasibility and securing funding to navigating scientific review processes, study initiation, continuing review procedures, and working effectively with sponsors.
Overview of Design Options for Pragmatic Clinical Trials
Module 1
Outcome Measures in Clinical Trials
Module 2
Non-inferiority Trials
Module 3
Basic Analytic Methods
Module 4
SMART: Adaptive Treatment Strategies
Module 6
Introduction to Bayesian Methods
Module 7
Bayesian Designs
Module 8
Quasi-Experiment in Health Services Research
Module 9
Adaptive Trial Design
Module 10
Logistics of Clinical Trials
Module 11
Fee Structure
Individual course purchase is not available - to enroll in this course with a certificate, you need to purchase the complete Professional Certificate Course. For enrollment and detailed fee structure, visit the following: CERTaIN: Mastering Comparative Effectiveness Research
Payment options
Financial Aid
Instructors

5 Courses
Barnts Family Distinguished Professor at The University of Texas MD Anderson Cancer Center
Dr. Suarez-Almazor is Professor and Deputy Chair in the Department of General Internal Medicine at The University of Texas MD Anderson Cancer Center in Houston, TX. She is Head of the Section of Rheumatology and Clinical Immunology.

1 Course
Professor and Interim Chair at The University of Texas Health Science Center at Houston, School of Public Health
Dr. Davis is Professor and Interim Chair of the Department of Biostatistics at The University of Texas Health Science Center at Houston (UTHealth), School of Public Health.
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