Run-in period explained

Run-in period is a period between the recruitment and randomization phases of a clinical trial,^{[1] [2]} when all participants receive the same treatment, which may be active treatment, a placebo or no treatment at all. The clinical data from this stage of a trial are only occasionally of value but can serve a valuable role in screening out ineligible or non-compliant participants, in ensuring that participants are in a stable condition, and in providing baseline observations.^[3] A run-in period is sometimes called a washout period if treatments that participants were using before entering the clinical trial are discontinued.

See also

• Data management
• Randomized controlled trial
• Safety monitoring
• Serious adverse event
• Standard operating procedures
• Standard treatment
• Study population

Notes and References

1. Laursen . David Ruben Teindl . Paludan-Müller . Asger Sand . Hróbjartsson . Asbjørn . Randomized clinical trials with run-in periods: frequency, characteristics and reporting . Clinical Epidemiology . Informa UK Limited . 11 . 2019 . 1179-1349 . 30809104 . 6377048 . 10.2147/clep.s188752 . 169–184 . free .
2. Web site: run-in period . https://web.archive.org/web/20160304031735/http://www.medilexicon.com/medicaldictionary.php?t=67147 . 2016-03-04 . Stedman's Medical Dictionary . 2006 . Lippincott Williams & Wilkins . MediLexicon.
3. Web site: Run-in periods in clinical trials: What can we ACHIEVE? . September 13, 2021 . NephJC . Manasi . Bapat.