Study Design

Understanding how building a strong study design benefits a research project is most advantageous at the beginning of the project. These modules assist learners in determining the best design for their research.

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'Overview of Study Designs' (502E00CMS090015)

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 selected design reflects an ideal balance of advantages and disadvantages. This module reviews some of these approaches.

'Study Designs Commonly Used in Clinical Research' (502E00CMS110020)

This module is designed for the investigator needing assistance in determining the design of a research study. Participants learn the fundamental concepts of a variety of study designs used in research studies and strengths and weaknesses of the designs. Participants explore the different randomization techniques and when it's best to use each.

'Study Design and the Hierarchy of Scientific Evidence' (502E00CMD090011)

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 helps learners navigate the trade-offs.

'Subject Selection' (502E00CMD090009)

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 discusses how to make these difficult decisions.

'Data Monitoring Committees' (502E00CMS110027)

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, researchers garner information regarding the clinical equipoise assumption and must reach decisions regarding the continuation of the study.

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.