Run-in period is a period between the recruitment and randomization phases of a clinical trial, 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. 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
References
- Laursen, David Ruben Teindl; Paludan-Müller, Asger Sand; Hróbjartsson, Asbjørn (2019). "Randomized clinical trials with run-in periods: frequency, characteristics and reporting". Clinical Epidemiology. 11. Informa UK Limited: 169–184. doi:10.2147/clep.s188752. ISSN 1179-1349. PMC 6377048. PMID 30809104.
- "run-in period". Stedman's Medical Dictionary. Lippincott Williams & Wilkins. 2006. Archived from the original on 2016-03-04 – via MediLexicon.
- Bapat, Manasi (September 13, 2021). "Run-in periods in clinical trials: What can we ACHIEVE?". NephJC.