Historical Control Subject

A Historical Control Subject is a test subject that has received treatment in the past, and therefore can be used for comparing and analyzing a clinical trial that had no control group.

• Example(s):
  • …
• Counter-Example(s):
  • Healthy Control,
  • Cohort Group,
  • Placebo Group,
  • Treatment Group.
• See: Retrospective Cohort Study, Placebo-Controlled Clinical Trial, Crossover Clinical Trial, Parallel Clinical Trial, Multi-Arm Clinical Trial, Dynamic Clinical Trial.

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References

2022

• (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research#H Retrieved:2022-02-05.
  • QUOTE: An individual treated in the past and used in a comparison group when researchers analyze the results of a clinical study that had no control group. The use of a control, or comparison, group helps researchers determine the effects of a new treatment more accurately. (NCI)

2020

• (Ghadessi et al., 2020) ⇒ Mercedeh Ghadessi, Rui Tang, Joey Zhou, Rong Liu, Chenkun Wang, Kiichiro Toyoizumi, Chaoqun Mei, Lixia Zhang, C. Q. Deng, and Robert A. Beckman. "A roadmap to using historical controls in clinical trials – by Drug Information Association Adaptive Design Scientific Working Group (DIA-ADSWG)". In: Orphanet Journal of Rare Diseases. Volume 15, Article number: 69.
  • QUOTE: Historical controls (HCs) can be used for model parameter estimation at the study design phase, adaptation within a study, or supplementation or replacement of a control arm. Currently on the latter, there is no practical roadmap from design to analysis of a clinical trial to address selection and inclusion of HCs, while maintaining scientific validity. This paper provides a comprehensive roadmap for planning, conducting, analyzing and reporting of studies using HCs, mainly when a randomized clinical trial is not possible.

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