Washout period is a term used in clinical trials to describe the length of time that someone enrolled in a trial must not receive any treatment before they are given the experimental therapy. This period of time may be required before joining a trial or before changing treatments within a trial. In metastatic breast cancer trials the washout period is often two to six weeks.
There are two major reasons researchers require a washout period: to study the effects of the therapy under investigation and to ensure the safety of people enrolled in the trial. However, trials with longer washout periods can be challenging for people with fast-growing or symptomatic tumors.
Because of patients’ and advocates’ concerns about the washout period, clinical trial regulators are working with researchers and patients to determine more appropriate guidelines for washout periods. Read the following articles to learn why washout periods are required, ethical issues related to requiring people to stop treatment, and potential solutions to patient concerns.
- Wash-Out Period: Your Questions, Answered This blog by Eli Lilly defines washout period.
- Washout Period or Withholding/Postponing Standard Treatment Guidance Example of guidelines for washout periods from the Health Sciences Institutional Review Boards, University of Wisconsin System.
- Let’s Talk About Clinical Trial Washouts An advocate on LungCancer.net discusses the problems with washout periods.
Last Modified on February 10, 2021