Clinical Trial Bias

A Clinical Trial Bias is a cognitive bias (or a clinical trial design flaw) that prevents impartial judgment and influences how a measurement (assessment, procedure, or analysis) is carried out or reported.

• AKA: Medical Bias.
• Example(s):
  • a clinical trial bias that results from a researcher or patient knowing what treatment is being given.
  • …
• Counter-Example(s):
  • Blinded Clinical Trial,
  • Good Clinical Practice,
  • Medical Guideline,
  • Medical Malpractice,
• See: Operational Bias, Statistical Bias, Inductive Bias, Clinical Trial Protocol, Medical Treatment, Clinical Trial Management System.

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References

2021a

• (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research Retrieved:2021-11-20.
  • QUOTE: Bias
    • In a scientific research study or clinical trial, a flaw in the study design or the method of collecting or interpreting information. Biases can lead to incorrect conclusions about what the study or clinical trial showed. (NCI)
    • When a point of view prevents impartial judgment on issues relating to the subject of that point of view. In clinical studies, bias is controlled by blinding and randomization (NLM)
    • The systematic tendency of any factors associated with the design, conduct, analysis and evaluation of the results of a clinical trial to make the estimate of a treatment effect deviate from its true value. Bias introduced through deviations in conduct is referred to as 'operational' bias. The other sources of bias listed above are referred to as 'statistical'. (ICH E9)

2021b

• (NIA/NIH, 2021) ⇒ https://www.nia.nih.gov/research/dgcg/nia-glossary-clinical-research-terms Retrieved:2021-11-20.
  • QUOTE: Bias – A point of view or preference which prevents impartial judgment in the way in which a measurement, assessment, procedure, or analysis is carried out or reported.

2021c

• (MedicineNet, 2021) ⇒ https://www.medicinenet.com/bias/definition.htm Retrieved:2021-11-20.
  • QUOTE: Bias: 1. When a point of view prevents impartial judgment on issues relating to the subject of that point of view. In a clinical trial, bias refers to effects that a conclusion that may be incorrect as, for example, when a researcher or patient knows what treatment is being given. To avoid bias, a blinded study may be done. 2. Deviation of results or inferences from the truth, or processes leading to such systematic deviation. Any trend in the collection, analysis, interpretation, publication, or review of data that can lead to conclusions that are systematically different from the truth.

2021d

• (NCI, 2021) ⇒ https://www.cancer.gov/publications/dictionaries/cancer-terms/def/bias Retrieved:2021-11-20.
  • QUOTE: In a scientific research study or clinical trial, a flaw in the study design or the method of collecting or interpreting information. Biases can lead to incorrect conclusions about what the study or clinical trial showed.

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