Clinical Trial Carryover Effect
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A Clinical Trial Carryover Effect is an Experimental Carryover Effect that is a treatment effect that can alter the clinical endpoint of a subsequent medical intervention/treatment.
- AKA: Treatment Residual Effect.
- Context:
- It can be eliminated by introducing a washout period between treatments.
- Example(s):
- Counter-Example(s):
- See: Within-Subjects research design. Washout Period, Treatment Period, Crossover Clinical Trial, Clinical Trial Eligibility Criterion, Concomitant Medication.
References
2016
- (Sturdevant & Lumley, 2016) ⇒ S. Gwynn Sturdevant, and Thomas Lumley (2016). "Testing for carryover effects after cessation of treatments: a design approach". In: BMC Medical Research Methodology 16.
- QUOTE: Reliably estimating carryover effects requires that incident hypertension is diagnosed without differential bias by treatment group, and rapidly enough to distinguish zero, short, and long-term carryover. Stephen Senn defines “direct effects” as the effect of a treatment while administered and “residual effects” as forms of carryover which occur after treatment has ceased (...)
2014
- (O'Connor et al., 2014) ⇒ Constance M. O'Connor, D. Ryan Norris, Glenn T. Crossin, Steven J. Cooke (2014). "Biological carryover effects: linking common concepts and mechanisms in ecology and evolution". In: Ecosphere, 5(3), 1-11.
- QUOTE: The concept of carryover effects was first recognized in repeated measures clinical trials, where certain factors could ‘carry over' from one treatment to another in laboratory studies (...)
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.