Uncertain benefit: investigators' views and communications in early phase gene transfer trials
نویسندگان
چکیده
منابع مشابه
Therapeutic misconception in early phase gene transfer trials.
Many subjects in early phase clinical trials expect to benefit in some way from the research intervention. It is understandable that people hope for improvement in their condition, no matter what the evidence. Yet unreasonable expectation of medical benefit may reflect problems with informed consent: Investigators may not disclose clearly that direct medical benefit from an early phase experime...
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BACKGROUND Non-inferiority (NI) trials in drug research are used to demonstrate that a new treatment is not less effective than an active comparator. Since phase IV trials typically aim at informing a clinical decision, the value of a phase IV non-inferiority trial hinges also on its clinical relevance. In such trials, clinical relevance would refer to the added benefit claims of a specific dru...
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Unrealistic optimism is a bias that leads people to believe, with respect to a specific event or hazard, that they are more likely to experience positive outcomes and/or less likely to experience negative outcomes than similar others. The phenomenon has been seen in a range of health-related contexts—including when prospective participants are presented with the risks and benefits of participat...
متن کاملElements of style: consent form language and the therapeutic misconception in phase 1 gene transfer trials.
The therapeutic misconception arises wherever human subjects misinterpret the primary purpose of a clinical trial as therapeutic. Such misconceptions are particularly prevalent in trials involving severely ill subjects or novel and well-publicized investigational agents. In order to identify possible sources of the therapeutic misconception in gene transfer trials, 286 phase 1 human gene transf...
متن کاملRandomized trials stopped early for benefit: a systematic review.
CONTEXT Randomized clinical trials (RCTs) that stop earlier than planned because of apparent benefit often receive great attention and affect clinical practice. Their prevalence, the magnitude and plausibility of their treatment effects, and the extent to which they report information about how investigators decided to stop early are, however, unknown. OBJECTIVE To evaluate the epidemiology a...
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ژورنال
عنوان ژورنال: Molecular Therapy
سال: 2004
ISSN: 1525-0016
DOI: 10.1016/j.ymthe.2004.05.013