crossover trial


Also found in: Dictionary, Thesaurus, Legal, Encyclopedia.

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 ?
One systematic review that looked at the efficacy of metoclopramide for gastroparesis identified one small RCT and 3 smaller placebo-controlled crossover trials. (1) The RCT (using 10 mg of metoclopramide after meals and at bedtime) found consistent improvement in the sense of fullness over 3 weeks of therapy, with reduction of nausea at one and 3 weeks, but not at 2 weeks.
A randomized 2 x 2 crossover trial was designed with one group randomly assigned to a normal-to-low-salt bread sequence and the other group to a low-to-normal-salt bread sequence (27).
Both aloe vera gel and whole leaf aloe were tested in the random crossover trial, with the gel demonstrating the strongest results in promoting the absorbance of vitamins C and B12.
An unpublished, placebo-controlled, double-blind crossover trial of 5 mg of melatonin on 16 children with autism or Asperger's syndrome found increases in total sleep time, shorter sleep latencies, and significant improvements in child functioning.
But the company's random-ized crossover trial in 48 HIV-negative volunteers who took Lexiva for two weeks with Nexium, and later for two weeks without, found that this did not happen, at least with the 20 mg dose of Nexium tested (the drug is supplied in 20 and 40 mg doses)--whether or not the Lexiva was "boosted" with a small dose of Norvir.
The program was designed as a self-help and home-based program over 6 weeks and compared to standard care within a randomised crossover trial in 16 patients with moderate heart failure NYHA class II-III.
This point emerges in Kulczycki and colleagues' short-term crossover trial, in which the majority of users rated the female condom as much less acceptable than the male condom on a wide range of features.
Researchers conducted a randomized, crossover trial of glicazide and metaformin in 36 patients who had either type 2 diabetes or diabetes caused by a genetic mutation HNF-la.
[15] Jacobsson et al published the results of a double-blind, placebo-controlled, crossover trial of budesonide.
The students, all regular coffee drinkers, were given grapefruit juice with or without caffeine during two different medical school exams in a double blind, placebo-controlled, randomized crossover trial. The combination of caffeine and a stressful situation caused blood pressure to increase significantly, with 48% of participants registering average systolic readings of 140mm HG or higher.
Kelvin Robertson, from The Townsville Hospital in Australia, and colleagues conducted a preplanned interim analysis of a randomized, double-dummy crossover trial of PGB and GBP for management of CS.