crossover trial

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crossover trial

A clinical trial design in which subjects act as their own control and are assigned to receive investigational product and controls in an order determined by randomisations, with a washout period between the two epochs.

crossover trial

A scientific study of a therapeutic agent in which participants are exposed in sequence to the putative cure and subsequently (or previously) to an inactive agent or an agent whose efficacy has been previously established. The participants cross over from one arm of the study to the other and serve as their own control group.

Participants in such trials are usually under the care of a team of physicians and nurses and are closely monitored, often with testing and examinations on a weekly basis. The clinical trial nurse or nurse research specialist has a broad variety of roles, depending on the nature of the investigation. The roles include recruiting and introducing patients to the trial, coordinating their care, gathering data about side effects and tolerance, and, frequently, serving as a principal or collaborative investigator. Trial planning and design, data interpretation and analysis, and assessments of toxicity are all elements of the work. Health insurers and managed care providers may place restrictions on clinical trial coverage. Many states have laws requiring insurers to pay for the routine costs of all or some clinical trials. Patient advocates work with researchers to make sure a clinical trial is relevant, as safe as possible, and accessible to the broadest variety of patients.

Synonym: crossover (2)
See also: trial
References in periodicals archive ?
Newton, Massachusetts-based clinical-stage biopharmaceutical company Stealth BioTherapeutics has completed enrollment in the TAZPOWER clinical trial, a phase 2/3, randomized, double-blind, placebo-controlled crossover study to evaluate the effects of daily treatment with elamipretide in 12 patients with genetically confirmed Barth syndrome, the company said.
7, 2018 -- A first-of-its-kind double-blind crossover study of children with autism treated with their own cord blood showed the treatment to be safe and suggests possible improvement in socialization.
A third study arm will evaluate safety and tolerability in patients with mild to moderate stable asthma and will also include PK analysis of itraconazole levels in the blood and sputum following administration of a single dose of oral itraconazole or Pulmazole in a crossover study design.
7, 2018 -- A first-of-its-kind double-blind crossover study of a treatment for children with autism using their own cord blood showed it to be safe and suggests possible improvement in socialization.
This US FDA's FTD follows the company's TAZPOWER, a Phase 2/3, randomised, double-blind, placebo-controlled crossover study that will evaluate the effects of daily treatment with elamipretide in patients with genetically confirmed Barth syndrome.
The Phase 2a portion of the trial is an open-label, multiple-dose, randomized, 3-period crossover study.
In this double-blind, randomized, crossover study, 36 patients with type 1 diabetes used individualized doses of either BioChaperone Lispro or Humalog as the short acting insulin in their multiple daily injection regimen, over two periods of 14 days.
In a randomized crossover study, rocuronium bromide (20 [micro]L/eye; 10 mg/mL) or saline (20 [micro]L/eye; 0.
PLoS One reported the outcome of a double-blind, crossover study that found supplementation with chondroitin sulfate and glucosamine hydrochloride, a nutritional combination used to alleviate symptoms of arthritis, was associated with a reduction in C-reactive protein (CRP), a marker of inflammation.
OPuS-1 was a double-blind, randomized crossover study in which 24 patients with severe HAE were assigned to 4 weeks of BCX4161 at 400 mg or placebo three times daily, then switched to 4 weeks of the other regimen after a washout period.
The crossover study or trial is a longitudinal study in which participants receive different interventions or an intervention and the control, usually the standard treatment, in a sequence.
PARIS -- Twice-daily dosing with aspirin worked substantially better for blocking platelet aggregation than did once-daily treatment with the same total dosage, in patients with diabetes and coronary artery disease in a single-center crossover study with 92 patients.