Run-in period
Run-in period is a term used in clinical trials to describe a preliminary period before the actual study begins. This period is used to stabilize the participants' conditions, eliminate the effects of previous treatments, and establish a baseline for comparison. The run-in period can also be used to assess the participants' compliance and suitability for the study.
Purpose
The main purpose of the run-in period is to ensure that all participants start the trial in a similar state. This helps to reduce the variability in the results and increase the accuracy of the findings. The run-in period can also be used to screen out participants who are unlikely to comply with the trial protocol or who experience adverse effects from the treatment.
Types of Run-in Periods
There are several types of run-in periods, including:
- Washout period: This is a period during which participants stop taking any previous treatments to eliminate their effects. This is particularly important in trials of new drugs, where the effects of the previous treatment could interfere with the results.
- Placebo run-in period: During this period, all participants are given a placebo to establish a baseline for comparison. This can also help to screen out participants who are likely to drop out of the trial or who experience placebo effects.
- Open-label run-in period: In this type of run-in period, all participants are given the active treatment to assess their response and tolerance. This can help to identify participants who are likely to benefit from the treatment and those who may experience adverse effects.
Criticisms
While the run-in period can improve the accuracy of clinical trials, it has also been criticized for potentially biasing the results. For example, by excluding participants who do not respond to the treatment during the run-in period, the trial may overestimate the effectiveness of the treatment. There are also ethical concerns about giving participants a placebo or withdrawing their current treatment during the run-in period.
See also
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Contributors: Prab R. Tumpati, MD
