Contemporary clinical trials
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Contemp Clin Trials · Jan 2009
Randomized Controlled Trial Multicenter StudyPioglitazone versus vitamin E versus placebo for the treatment of non-diabetic patients with non-alcoholic steatohepatitis: PIVENS trial design.
Non-alcoholic steatohepatitis (NASH) is a common liver disease associated with obesity and diabetes. NASH is a progressive disorder that can lead to cirrhosis and liver failure. Insulin resistance and oxidative stress are thought to play important roles in its pathogenesis. There is no definitive treatment for NASH. ⋯ PIVENS enrollment started in January 2005 and ended in January 2007 with 247 patients randomized to receive either pioglitazone (30 mg q.d.), vitamin E (800 IU q.d.), or placebo for 96 weeks. Participants will be followed for an additional 24 weeks after stopping the treatment. The study protocol incorporates the use of several validated questionnaires and specimen banking. This protocol was approved by all participating center Institutional Review Boards (IRBs) and an independent Data and Safety Monitoring Board (DSMB) which was established for monitoring the accumulated interim data as the trial progresses to ensure patient safety and to review efficacy as well as the quality of data collection and overall study management. (ClinicalTrials.gov number, NCT00063622).
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Contemp Clin Trials · Jan 2009
Randomized Controlled Trial Multicenter Study Comparative StudyThe Prostate cancer Intervention Versus Observation Trial:VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline results of a randomized controlled trial comparing radical prostatectomy to watchful waiting for men with clinically localized prostate cancer.
Prostate cancer is the most common noncutaneous malignancy and the second leading cause of cancer death in men. Ninety percent of men with prostate cancer are over aged 60 years, diagnosed by early detection with the prostate specific antigen (PSA) blood test and have disease believed confined to the prostate gland (clinically localized). Common treatments for clinically localized prostate cancer include watchful waiting surgery to remove the prostate gland (radical prostatectomy), external beam radiation therapy and interstitial radiation therapy (brachytherapy) and androgen deprivation. Little is known about the relative effectiveness and harms of treatments due to the paucity of randomized controlled trials. The VA/NCI/AHRQ Cooperative Studies Program Study #407: Prostate cancer Intervention Versus Observation Trial (PIVOT), initiated in 1994, is a multicenter randomized controlled trial comparing radical prostatectomy to watchful waiting in men with clinically localized prostate cancer. ⋯ PIVOT enrolled an ethnically diverse population representative of men diagnosed with prostate cancer in the United States. Results will yield important information regarding the relative effectiveness and harms of surgery compared to watchful waiting for men with predominately PSA detected clinically localized prostate cancer.
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Contemp Clin Trials · Nov 2008
Multicenter StudyRecruitment of minority and underserved populations in the United States: the Centers for Population Health and Health Disparities experience.
The recruitment of minority and underserved individuals to research studies is often problematic. The purpose of this study was to describe the recruitment experiences of projects that actively recruited minority and underserved populations as part of The Centers for Population Health and Health Disparities (CPHHD) initiative. ⋯ Recruitment of minority and underserved populations to clinical trials is necessary to increase study generalizbility and reduce health disparities. Our results demonstrate the importance of flexible study designs which allow adaptation to recruitment challenges. These experiences also highlight the importance of involving community members and reducing participant burden to achieve success in recruiting individuals from minority and underserved populations.
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Contemp Clin Trials · Jul 2008
Randomized Controlled Trial Multicenter StudyCan regional analgesia reduce the risk of recurrence after breast cancer? Methodology of a multicenter randomized trial.
Surgery is the primary and most effective treatment of breast cancer, but minimal residual disease is probably unavoidable. Whether residual disease results in clinical metastases depends on numerous factors, including anti-tumor cell mediated immunity and angiogenic and growth signals in sites of residual disease. At least three perioperative factors adversely affect these: 1) the neuroendocrine stress response to surgery, 2) volatile anesthetics, and 3) opioids. ⋯ Enrolling 1100 patients over 5 years will provide 85% power for detecting a 30% treatment effect at an alpha of 0.05. We plan four equally spaced interim analyses, each evaluating efficacy and futility. Confirming our hypothesis will indicate that a small modification to anesthetic management, one that can be implemented with little risk or cost, will reduce the risk of cancer recurrence - a complication that is often ultimately lethal.
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Contemp Clin Trials · May 2008
Randomized Controlled Trial Multicenter StudyElectronic communications and home blood pressure monitoring (e-BP) study: design, delivery, and evaluation framework.
Randomized controlled trials have provided unequivocal evidence that treatment of hypertension decreases mortality and major disability from cardiovascular disease; however, blood pressure remains inadequately treated in most affected individuals. This large gap continues despite the facts that more than 90% of adults with hypertension have health insurance, and hypertension is the leading cause of visits to the doctor. New approaches are needed to improve hypertension care. ⋯ We will determine whether a new model of patient-centered care that leverages Web communications, self-monitoring, and collaborative care management improves hypertension control. If this model proves successful and cost-effective, similar interventions could be used to improve the care of large numbers of patients with uncontrolled hypertension.