Contemporary clinical trials
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Contemp Clin Trials · May 2014
Pilot and feasibility studies: is there a difference from each other and from a randomised controlled trial?
A crucial part in the development of any intervention is the preliminary work carried out prior to a large-scale definitive trial. However, the definitions of these terms are not clear cut and many authors redefine them. Because of this, the terms feasibility and pilot are often misused. ⋯ We believe that the term 'feasibility' should be used as an overarching term for preliminary studies and the term 'pilot' refers to a specific type of study which resembles the intended trial in aspects such as, having a control group and randomisation. However, studies labelled 'pilot' should have different aims and objectives to main trials and also should include an intention for future work. Researchers should not use the title 'pilot' for a trial which evaluates a treatment effect.
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Contemp Clin Trials · May 2014
Randomized Controlled Trial Multicenter Study Clinical TrialImproving efficiency and reducing costs: Design of an adaptive, seamless, and enriched pragmatic efficacy trial of an online asthma management program.
Clinical trials are critical for medical decision-making, however, under the current paradigm, clinical trials are fraught with problems including low enrollment and high cost. Promising alternatives to increase trial efficiency and reduce costs include the use of (1) electronic initiatives that permit electronic remote data capture (EDC) for direct data collection at a site (2), electronic medical records (EMR) for patient identification and data collection, and (3) adaptive, enrichment designs with pragmatic approaches. We describe the design of a seamless, multi-site randomized Phase II/III trial to evaluate an asthma management intervention in urban adolescents with asthma. ⋯ A centralized database with EDC is used for CRF data collection with integration of EMR data. This Phase II/III trial plans to have a total sample size of 500 patients with an interim look at the completion of Phase II (n=250), The interim analyses include an assessment of the intervention effect, marker(s) identification and the feasibility study of EMR data as the trial CRF data collection. Patient enrollment has begun and is ongoing.
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Contemp Clin Trials · May 2014
Randomized Controlled TrialThe Vitamin D Antenatal Asthma Reduction Trial (VDAART): rationale, design, and methods of a randomized, controlled trial of vitamin D supplementation in pregnancy for the primary prevention of asthma and allergies in children.
There is intense interest in the role of vitamin D in the development of asthma and allergies. However, studies differ on whether a higher vitamin D intake or status in pregnancy or at birth is protective against asthma and allergies. To address this uncertainty, the Vitamin D Antenatal Asthma Reduction Trial (VDAART) was developed. ⋯ Monthly monitoring of urinary calcium to creatinine ratio was performed in addition to medical record review for adverse events. Offspring are being evaluated quarterly through questionnaires and yearly during in-person visits until the 3rd birthday of the child. Ancillary studies will investigate neonatal T-regulatory cell function, maternal vaginal flora, and maternal and child intestinal flora.
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Contemp Clin Trials · May 2014
Randomized Controlled Trial Multicenter StudyStudy of Tomography Of Nephrolithiasis Evaluation (STONE): methodology, approach and rationale.
Urolithiasis (kidney stones) is a common reason for Emergency Department (ED) visits, accounting for nearly 1% of all visits in the United States. Computed tomography (CT) has become the most common imaging test for these patients but there are few comparative effectiveness data to support its use in comparison to ultrasound. This paper describes the rationale and methods of STONE (Study of Tomography Of Nephrolithiasis Evaluation), a pragmatic randomized comparative effectiveness trial comparing different imaging strategies for patients with suspected urolithiasis. ⋯ The detailed methodology of STONE will provide a roadmap for comparative effectiveness studies of diagnostic imaging conducted in an ED setting.