Contemporary clinical trials
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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 · Jul 2008
Randomized Controlled TrialThe Self-Management of OsteoArthritis in Veterans (SeMOA) Study: design and methodology.
Osteoarthritis (OA) is a leading cause of disability among adults. Although self-management behaviors such as exercise and weight management can improve pain and function, these behaviors are vastly underutilized. There is a need to implement effective self-management programs among the growing number of adults with OA. ⋯ SeMOA is one of the first to examine telephone-based delivery of OA self-management and one of few trials to target the primary care setting. This program has the potential for broad dissemination because it reduces both the costs and barriers that accompany in-person programs. This study will provide important information about its feasibility and effectiveness in a real-world clinical setting.
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Contemp Clin Trials · Jul 2008
Comparative StudyDetermination of required content of the informed consent process for human participants in biomedical research conducted in the U.S. A practical tool to assist clinical investigators.
Clinical Investigators conducting biomedical research involving human participants in the U. S. are responsible for the content of the consent document(s) and for the conduct of the informed consent conference(s) with the human participants. The content of the consent forms and consent process may be governed by two different sets of U. ⋯ This article compares the two sets of U. S. regulations and two sets of well-respected international guidelines with respect to their requirements for the content of the consent document and consent conference. A practical decision tree is proposed as a tool to assist Investigators in determining which set(s) of requirements is applicable to a particular study.