Clinical study design

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Clinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research (e.g., epidemiological) involving human beings.[1]

Some of the considerations here are shared under the more general topic of design of experiments but there can be others, in particular related to patient confidentiality and ethics.

Outline of types of designs for clinical studies[edit]

Treatment studies[edit]

Observational studies[edit]

Important considerations[edit]

When choosing a study design, many factors must be taken into account. Different types of studies are subject to different types of bias. For example, recall bias is likely to occur in cross-sectional or case-control studies where subjects are asked to recall exposure to risk factors. Subjects with the relevant condition (e.g. breast cancer) may be more likely to recall the relevant exposures that they had undergone (e.g. hormone replacement therapy) than subjects who don't have the condition.

The ecological fallacy may occur when conclusions about individuals are drawn from analyses conducted on grouped data. The nature of this type of analysis tends to overestimate the degree of association between variables.

Seasonal studies[edit]

Conducting studies in seasonal indications (such as allergies, Seasonal Affective Disorder, influenza, and others) can complicate a trial as patients must be enrolled quickly. Additionally, seasonal variations and weather patterns can affect a seasonal study.[2][3]

Other terms[edit]

See also[edit]

References[edit]

  1. ^ Miquel Porta (2014) "A dictionary of epidemiology", 6th edn, New York: Oxford University Press. ISBN 9780199976737.
  2. ^ Yamin Khan and Sarah Tilly. "Flu, Season, Diseases Affect Trials". Applied Clinical Trials Online. Retrieved 26 February 2010. 
  3. ^ Yamin Khan and Sarah Tilly. "Seasonality: The Clinical Trial Manager's Logistical Challenge". published by: Pharm-Olam International (POI). Retrieved 26 April 2010. 

External links[edit]