Contemporary clinical trials
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Contemp Clin Trials · Nov 2011
Randomized Controlled Trial Multicenter Study Comparative StudyIMProving Adherence using Combination Therapy (IMPACT): design and protocol of a randomised controlled trial in primary care.
Cardiovascular disease (CVD) is the leading cause of death, and principal reason for the large difference in life expectancy between indigenous Māori and the non-indigenous population in New Zealand. CVD guidelines recommend that people who are at high risk or who have had previous CVD should be offered aspirin, blood pressure lowering and lipid lowering therapies. However, prescribing and adherence rates are low and CVD events remain high. ⋯ IMProving Adherence using Combination Therapy (IMPACT) is an open-label randomised controlled trial comparing a once-daily polypill containing four preventive medications with usual care. Six hundred participants who have had previous CVD events or are at high risk of CVD will be enrolled, including 300 Māori. Participants are identified, enrolled and prescribed either the polypill or current medications at their usual primary health care practice, with medications (including the polypill) dispensed through local community pharmacies. The polypill contains 75 mg aspirin, 40 mg simvastatin, 10mg lisinopril and either 12.5mg hydrochlorothiazide or 50mg atenolol. Primary outcomes are adherence to guidelines-recommended medications and changes in systolic blood pressure and low density lipoprotein at 12 months. Secondary outcomes include other lipids, medication dispensing, barriers to adherence, CVD and other serious adverse events, quality of life and prescriber acceptability. The trial is registered with the Australian New Zealand Clinical Trial Registry (ACTRN12606000067572).
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Contemp Clin Trials · Nov 2011
Randomized Controlled Trial Multicenter Study Comparative StudyA community randomised controlled trial evaluating a home-based environmental intervention package of improved stoves, solar water disinfection and kitchen sinks in rural Peru: rationale, trial design and baseline findings.
Pneumonia and diarrhoea are leading causes of death in children. There is a need to develop effective interventions. ⋯ Randomization resulted in comparable study arms. Recently, several critical reviews raised major concerns on the reliability of open health intervention trials, because of uncertain sustainability and non-blinding bias. In this regard, the presented trial featuring objective outcome measures, a simultaneous intervention in the control communities and a 12-month follow up period will provide valuable evidence.
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Contemp Clin Trials · May 2010
Multicenter Study Comparative StudyA simulation-based comparison of the traditional method, Rolling-6 design and a frequentist version of the continual reassessment method with special attention to trial duration in pediatric Phase I oncology trials.
The traditional method (TM), also known as the 3+3 up-and-down design, and the continual reassessment method (CRM) are commonly used in Phase I oncology trials to identify the maximum tolerated dose (MTD). The rolling-6 is a relative newcomer which was developed to shorten trial duration by minimizing the period of time during which the trial is closed to accrual for toxicity assessment. In this manuscript we have compared the performance of these three approaches via simulations not only with respect to the usual parameters such as overall toxicity, sample size and percentage of patients treated at doses above the MTD but also in terms of trial duration and the dose chosen as the MTD. ⋯ With respect to trial duration, rolling-6 leads to shorter trials compared to the TM but not compared to the CRM. Additionally, the doses identified as the MTD by the TM and the rolling-6 differ in a large percentage of trials. Our results also indicate that the body surface area-based dosing used in pediatric trials can make a difference in dose escalation/de-escalation patterns in the CRM compared to the cases where such variations are not taken into account in the calculations, even leading to different MTDs in some cases.
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Contemp Clin Trials · Mar 2010
Randomized Controlled Trial Multicenter StudyA multi-site, two-phase, Prescription Opioid Addiction Treatment Study (POATS): rationale, design, and methodology.
The National Institute on Drug Abuse Clinical Trials Network launched the Prescription Opioid Addiction Treatment Study (POATS) in response to rising rates of prescription opioid dependence and gaps in understanding the optimal course of treatment for this population. POATS employed a multi-site, two-phase adaptive, sequential treatment design to approximate clinical practice. The study took place at 10 community treatment programs around the United States. ⋯ Eligible participants entering Phase 2 were re-randomized to either EMM or SMM. POATS was developed to determine what benefit, if any, EMM offers over SMM in short-term and longer-term treatment paradigm. This paper describes the rationale and design of the study.
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Contemp Clin Trials · Mar 2009
Randomized Controlled Trial Multicenter Study Comparative StudyOperations and pelvic muscle training in the management of apical support loss (OPTIMAL) trial: design and methods.
The primary aims of this trial are: 1) to compare surgical outcomes following sacrospinous ligament fixation to uterosacral vaginal vault suspension in women undergoing vaginal surgery for apical or uterine pelvic organ prolapse and stress urinary incontinence and 2) to examine the effects of a structured perioperative program consisting of behavioral techniques and pelvic floor muscle training compared to usual care. This trial is performed through the Pelvic Floor Disorders Network (PFDN), which is funded by National Institute of Child Health and Human Development. Subjects will be enrolled from hospitals associated with seven PFDN clinical centers across the United States. ⋯ The primary surgical endpoint is a composite outcome defined by anatomic recurrence, recurrence of bothersome vaginal prolapse symptoms and/or retreatment and will be assessed 2 years after the index surgery. Endpoints for the behavioral intervention include both short-term (6-month) improvement in urinary symptoms and long-term (2-year) improvement in anatomic outcomes and prolapse symptoms. This article describes the rationale and design of this randomized trial, focusing on several key design features of potential interest to researchers in the field of female pelvic floor disorders and others conducting randomized surgical trials.