Study Design

Understanding how building a strong study design will benefit your research is most advantageous at the beginning of your research project. These modules will assist you in determining the best design for your research.

CME: Mayo Clinic College of Medicine and Science is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Mayo Clinic College of Medicine and Science designates this enduring material for a maximum of 1 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Mayo Clinic employees: Enroll now

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"Overview of Study Designs"

Did you choose the strongest study design based on your research? There's usually more than one approach. It's best to consider several approaches so that the design you ultimately select reflects an ideal balance of advantages and disadvantages. This module will review some of these approaches. No CME credit is available.

Presenter: James R. Cerhan, M.D., Ph.D.

"Study Designs Commonly Used in Clinical Research"

This workshop is designed for the investigator needing assistance in determining the design of a research study. Participants will learn the fundamental concepts of a variety of study designs used in research studies, as well as the strengths and weaknesses of the designs. Participants explore the different randomization techniques and when it's best to use each. No CME credit is available.

Complexity: Introductory Presenter: Rickey E. Carter, Ph.D. Non-Mayo participants: Enroll now

"Study Design and the Hierarchy of Scientific Evidence"

Strong study designs yield answers that permit strong statements. Some designs come at a price in terms of feasibility and application to other real-life settings. This module will help you navigate the trade-offs. No CME credit is available.

Presenter: James R. Cerhan, M.D., Ph.D.

"Subject Selection"

To whom will your study results apply? The answer to this question depends in large part on whom you enroll in the study. This module will discuss how to make these difficult decisions. No CME credit is available.

Presenter: James R. Cerhan, M.D., Ph.D.

"Data Monitoring Committees"

The Mayo Clinic Institutional Review Board recently issued a guidance document on Data and Safety Monitoring Plan (DSMP) guidelines (Guidance IRB 10379.002). Elements of a DSMP include study- and participant-stopping rules. All randomized clinical trials must begin with the assumption of clinical equipoise — that either treatment represents a viable alternative.

As a study accrues participants, information regarding the clinical equipoise assumption is garnered and decisions regarding the continuation of the study must be reached. This module addresses many of the logistical aspects associated with interim monitoring of clinical studies, with emphasis on efficacy evaluation, while providing guidance on appropriate statistical considerations for the repeated evaluation of the study data. No CME credit is available.

Presenter: Rickey E. Carter, Ph.D.