Clinical trials : journal of the Society for Clinical Trials
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Sample size decisions for clinical trials should be taken in such a way as to maximize informed choice by reducing scientific uncertainty about the consequences of an intervention. ⋯ The approach is a pragmatic aid to trial design in settings where patient preference drives the choice between alternative treatments.
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The analysis of clinical trials with dropout usually assumes the missing data are ;missing at random', i.e. given an individual's past observed data, their probability of dropout does not depend on their present outcome. However, in many settings this assumption is implausible, so it is sensible to assess the robustness of conclusions to departures from missing at random. ⋯ Our proposed approach allows for the greater uncertainty introduced by missing data that are potentially informatively missing. It can therefore claim to be a truly conservative method, unlike methods such as ;last observation carried forward'. It is practical and accessible to non-statisticians. It should be considered as part of the design and analysis of future clinical trials.
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Intention-to-treat (ITT) is an approach to the analysis of randomized controlled trials (RCT) in which patients are analyzed as randomized regardless of the treatment actually received. ⋯ This study emphasizes that authors use the label ;intention-to-treat' quite differently. The most common use refers to the analysis of all available subjects as randomized regardless of the missing data aspect.
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Traditionally, phase I clinical trial designs are based upon one predefined course of treatment while varying among patients the dose given at each administration. In actual medical practice, patients receive a schedule comprised of several courses of treatment, and some patients may receive one or more dose reductions or delays during treatment. Consequently, the overall risk of toxicity for each patient is a function of both actual schedule of treatment and the differing doses used at each adminstration. ⋯ Our design is the first for phase I clinical trials that is sufficiently flexible and practical to truly reflect clinical practice by varying both dose and the timing and number of administrations given to each patient.
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Disclosing financial interests to potential research participants during the informed consent process is one strategy for managing conflicts of interest. Given that clinical research coordinators are typically charged with administering the informed consent process, it is critical to understand their experiences, attitudes and beliefs regarding the disclosure of financial interests in research. ⋯ Making information about financial interests in research readily available to clinical research coordinators, as well as providing education and training, should facilitate the disclosure of financial interests in research to potential research participants during the informed consent process.