NeuAge Institute (NAI)

The Essentials of Clinical Research Design for Those Considering Clinical Research Training

One goal during clinical research training is to learn to design studies that are able to derive valid and meaningful scientific conclusions. To do this, students at the NeuAge Institute develop the specialized knowledge and skills required to write study protocols, monitor and manage clinical trials, and conduct clinical trial-related activities.

This all starts with clinical research design, which allows NAI graduates to play a vital role in the protection of the study participant as well as the general public for marketed drugs. A great clinical research design reduces the time between drug development and market approval, indicating the importance of careful curation. Continue reading to learn about the two main types of clinical study design.

An Overview of Observational Studies 

Observational studies ask the questions of what, who, where, and when. They’re used when the researcher needs only to observe the participants in order to assess the effect of a risk factor, diagnostic test, treatment, or other intervention without dictating who is or isn’t exposed to it. 

An example of observational studies, called cohort studies, compare two groups, such as the subjects with exposure to the subjects without exposure, for differences in outcome. These allow for hypothesis testing to interpret if a causal relationship exists between exposure and outcome, but can’t determine it due to a lack of controlled variables. Other examples of observational studies include case reports, case series, ecologic studies, cross-sectional studies, and case-control studies.

clinical research courses
Observational studies don’t require intervention and rely on natural exposure and outcomes

Understanding an Experimental Study Design After Clinical Research Training

Experimental studies are designed differently than observational studies, requiring an intervention to assess risk. These are likely what you will be most familiar with following clinical research training. Whereas observational designs are helpful in interpreting a causal relationship between exposure and outcome, experimental designs are able to define the level of causality. The designs of these studies are thus meticulously planned to ensure accuracy in all results.

Experimental studies are most often randomized, meaning that subjects are picked and assigned groups by chance. They also usually involve a control group, where the participants have not been exposed to the intervention, and are used as a comparison group. Clinical trials, community trials, and field trials are all examples of experimental designs aimed at determining the impact of a specific intervention.

clinical research training
As you’ll learn in clinical research training, experimental design requires an intervention, which is used alongside a control group

Strengths and Weaknesses of Each Clinical Study Design

The strengths and weaknesses of research design options can differ depending on the question that the study is trying to answer. The clinical research program at NAI introduces students to the main steps of the drug development process, from drug discovery and preclinical testing to all phases of clinical research and post-approval drug safety surveillance in the US and worldwide. At different points during the research process, looking at different forms of research design may prove to be helpful.

Observational studies find their strengths in answering questions that we aren’t able to apply an intervention to. An example could be assessing risk when exposed to harmful chemicals, where it would be unethical to actually create an intervention exposing individuals to these substances. Because there is little control in observational studies, a weakness would be the lack of causality.

Randomized experimental studies are generally the gold standard, as they are able to draw more complete conclusions based on in-depth research. However, these studies are often expensive and time-consuming, posing weaknesses that should be considered. With careful attention to detail and a comprehensive understanding of the question at hand, clinical research students can learn to curate effective and powerful research designs.

Interested in starting clinical research courses?

Contact the NeuAge Institute for more information!

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