Washout Period
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A Washout Period is a Time Period that a clinical trial participant has to wait until he/she can receive new treatment so that any potential carry-over effects from previous treatments are eliminated.
- AKA: Run-in Period.
- Context:
- It can take place before a clinical trial starts or in between treatments.
- Example(s):
- In a crossover clinical trial is the time period a patient has to wait before he/she can receive the second treatment:
. - a NCT03068312 8-week washout period:
. - ...
- …
- In a crossover clinical trial is the time period a patient has to wait before he/she can receive the second treatment:
- Counter-Example(s):
- See: Clinical Trial Carryover Effect, Crossover Clinical Trial, Clinical Trial Eligibility Criterion, Treatment Effect, Side Effect, Adverse Effect, Placebo Effect, Nocebo Effect, Concomitant Medication.
References
2022
- (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Run-in_period Retrieved:2022-1-16.
- Run-in period is a period before a clinical trial is commenced, it can be passive "when a placebo or no treatment is given" or active "when treatment is used". 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.
2021a
- (Harvey et al., 2021) ⇒ R. Donald Harvey, Kathryn F. Mileham, Vishal Bhatnagar, Jamie Brewer, Atiqur Rahman, Cassadie Moravek, Andrew S. Kennedy, Elizabeth A. Ness, E. Claire Dees, S. Percy Ivy, Scot Ebbinghaus, Caroline Schenkel, and Thomas S. Uldrick (2021). "Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Washout Period and Concomitant Medication Work Group". In: Clinical Cancer Research 27(9): 2400–2407.
- QUOTE: A washout period is defined as a time between treatment periods that is intended to prevent mis-interpreting observations about study-related treatments that were actually due to prior therapies. Generally, washout/waiting periods prior to enrollment are employed in cancer trials following surgery, radiation, cytotoxic chemotherapy, small molecule/tyrosine kinase inhibitors, monoclonal antibodies (with and without drug conjugates), and immunotherapies.
2021b
- (Kerem et al., 2021) ⇒ Eitan Kerem, Malena Cohen-Cymberknoh, Reuven Tsabari, Michael Wilschanski, Joel Reiter, David Shoseyov, Alex Gileles-Hillel, Thea Pugatsch, Jane C. Davies, Christopher Short, Clare Saunders, Cynthia DeSouza, James C. Sullivan, Jamie R. Doyle, Keval Chandarana, and Nils Kinnman (2021). "Ivacaftor in people with cystic fibrosis and a 3849+ 10kb C→ T or D1152H residual function mutation". In: Annals of the American Thoracic Society, 18(3), 433-441.
- QUOTE: This was a phase 3b, randomized, double-blind, placebo-controlled, single-center crossover study in people with CF $geq 6$ years of age with a $3849 + 10kb\; C\to T$ or D1152H CFTR gene mutation and percentage predicted forced expiratory volume in 1 second (ppFEV1) of $geq 40\%$ and $\leq105\%$ at screening (NCT03068312). Participants were randomized (1:1) to one of two sequences (ivacaftor→ placebo or placebo→ivacaftor) that included two 8-week treatment periods with ivacaftor (150 mg every 12 h) or matching placebo, separated by an 8-week washout period (Figure 1).
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2021c
- (Meta Statistic Trial Talk, 2021) ⇒ https://metastatictrialtalk.org/inside-clinical-trials/washout-period/ Last Modified on March 14, 2021.
- QUOTE: In clinical trials, a washout period describes the length of time that someone enrolled in a trial must not receive any treatment before receiving the trial's experimental therapy. A washout 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 primary 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(...)
- QUOTE: In clinical trials, a washout period describes the length of time that someone enrolled in a trial must not receive any treatment before receiving the trial's experimental therapy. A washout 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.
2018
- (Elkins, 2018) ⇒ Ivy Elkins (April 18, 2018)."Let’s Talk About Clinical Trial Washouts". In: LungCancer.net.
- QUOTE: (...) What is a washout period? According to the U.S. National Library of Medicine, a washout period is defined as “a period of time during a clinical study when a participant is taken off a study drug or other medication in order to eliminate the effects of the treatment.” So basically, it means a time when a lung cancer patient is not being actively treated for his or her cancer while waiting for a new treatment to begin. Many lung cancer clinical trials require washout periods prior to starting the investigational medication. Don’t get me wrong, I understand why these washout periods are included — investigators want to know the impact of their new treatments independent of other influences that might affect the results(...)
2011
- (Evans, 2011) ⇒ Scott R. Evans (2011). "Clinical Trial Structures". In: Journal of Experimental Stroke & Translational Medicine, 3(1):8-18.
- QUOTE: The primary concern with crossover trials is the potential “carry-over effect”. If the residual effect of the treatment provided in the first period continues into the second period when assessments of the second treatment are made (despite the discontinuation of the treatment at the end of the first period), then treatment comparisons could be biased since one cannot distinguish between the treatment effect and the carry-over effect. For this reason, a “washout” period is often built into the study design to separate two treatment periods to eliminate “carry-over” effects. A frequent recommendation is for the washout period to be at least 5 times the half-life of the treatment with the maximum half-life in the study. Endpoint evaluations can also be made at the end of a period to allow more time for the effects of prior treatments to dissipate.