Controls in clinical trials

Control group – a group of participants that do not receive the drug or treatment being studied in the trial but instead receive standard of care or a placebo.

Kinds of controls

The FDA regulations cite five different kinds of controls that can be useful in particular circumstances:

1. Placebo concurrent control: A comparison between subjects treated with the new agent and those receiving a placebo
2. Dose-comparison concurrent control: A comparison between subjects treated with different doses of the new agent
3. No-treatment concurrent control: A comparison between subjects treated with the new agent and those receiving no treatment
4. Active-treatment concurrent control: A comparison between subjects treated with the new agent and those receiving an active treatment
5. Historical control: A comparison between subjects treated with the new agent and historical data from previous studies

External links

• FDA web site, ICH Guidance Documents, 29 Mar 2018, [ttps://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/ich-guidance-documents https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/ich-guidance-documents]
• EMA, ICH E10 Choice of control group in clinical trials, 01 Jan 2021, https://www.ema.europa.eu/en/ich-e10-choice-control-group-clinical-trials-scientific-guideline
• OJRD, A roadmap to using historical controls in clinical trials, 12 March 2020, https://ojrd.biomedcentral.com/articles/10.1186/s13023-020-1332-x