CERTaIN: Pragmatic Clinical Trials and Healthcare Delivery Evaluations

Course Overview

CERTaIN: Pragmatic Clinical Trials and Healthcare Delivery Evaluations is a course designed to provide an overview of the options a researcher must consider when embarking on clinical research. Experts will discuss the key decisions a researcher needs to make when preparing for and conducting research, as well as tools for data analysis. Participants will learn what a pragmatic clinical trial is and how to calculate power and sample size for their study. They will also be exposed to more complex study designs such as Bayesian and adaptive designs. The course consists of 11 lectures covering topics such as 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, and logistics of clinical trials. This course is intended for anyone interested in comparative effectiveness research (CER) and patient-centered outcomes research (PCOR) methods and is supported by grant number R25HS023214 from the Agency for Healthcare Research and Quality.

[Applications]
Upon completion of this course, participants should be able to apply the knowledge gained to design and conduct pragmatic clinical trials and healthcare delivery evaluations. They should be able to select appropriate outcome measures, calculate power and sample size, and understand the logistics of clinical trials. Participants should also be able to apply more complex study designs such as Bayesian and adaptive designs. Finally, they should be able to apply the knowledge gained to comparative effectiveness research (CER) and patient-centered outcomes research (PCOR) methods.

[Career Paths]
Three job position paths recommended for learners of this course are:

1. Clinical Research Coordinator: Clinical research coordinators are responsible for the day-to-day operations of clinical trials. They are responsible for recruiting and enrolling participants, collecting and managing data, and ensuring compliance with regulations. The demand for clinical research coordinators is expected to grow as the number of clinical trials increases.

2. Clinical Data Analyst: Clinical data analysts are responsible for analyzing and interpreting data from clinical trials. They use statistical methods to identify trends and patterns in the data, and develop reports and presentations to communicate their findings. The demand for clinical data analysts is expected to grow as the need for data-driven decision-making increases.

3. Clinical Trial Manager: Clinical trial managers are responsible for the overall management of clinical trials. They are responsible for developing and implementing trial protocols, managing budgets, and ensuring compliance with regulations. The demand for clinical trial managers is expected to grow as the number of clinical trials increases.

[Education Paths]
Three degree paths that are recommended for learners of this course are:

1. Master of Science in Clinical Research: This degree program provides students with the knowledge and skills necessary to design, conduct, and analyze clinical research. Students will learn about the ethical and legal considerations of clinical research, as well as the principles of evidence-based medicine. They will also gain an understanding of the principles of clinical trial design, data analysis, and interpretation. This degree program is ideal for those interested in pursuing a career in clinical research or healthcare delivery evaluation.

2. Master of Science in Health Services Research: This degree program focuses on the study of healthcare delivery systems and the impact of policy on healthcare outcomes. Students will learn about the principles of health services research, including the design and implementation of research studies, data analysis, and interpretation. They will also gain an understanding of the ethical and legal considerations of health services research. This degree program is ideal for those interested in pursuing a career in health services research or healthcare delivery evaluation.

3. Master of Science in Biostatistics: This degree program provides students with the knowledge and skills necessary to design, conduct, and analyze clinical research. Students will learn about the principles of biostatistics, including data analysis, statistical modeling, and interpretation. They will also gain an understanding of the ethical and legal considerations of clinical research. This degree program is ideal for those interested in pursuing a career in biostatistics or healthcare delivery evaluation.

The development trends for these degree paths are increasing demand for professionals with expertise in clinical research, health services research, and biostatistics. As healthcare delivery systems become more complex, there is a need for professionals who can design, conduct, and analyze research studies to evaluate the effectiveness of healthcare delivery systems. Additionally, there is an increasing demand for professionals who can use data to inform healthcare policy decisions.