Clinical trials : journal of the Society for Clinical Trials
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Randomized Controlled Trial
A randomized trial of the clinical utility of genetic testing for obesity: design and implementation considerations.
Obesity rates in the United States have escalated in recent decades and present a major challenge in public health prevention efforts. Currently, testing to identify genetic risk for obesity is readily available through several direct-to-consumer companies. Despite the availability of this type of testing, there is a paucity of evidence as to whether providing people with personal genetic information on obesity risk will facilitate or impede desired behavioral responses. ⋯ This randomized trial examines value of obesity genetic information, both when provided independently and when combined with lifestyle risk assessment, to motivate individuals to engage in healthy lifestyle behaviors. Study findings will guide future intervention efforts to effectively communicate genetic risk information.
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Sharing data from clinical trials could assist with the advancement of science and medicine, potentially providing a better understanding of both the benefits and risks of medicines and other treatments. Sharing data also allows for questions to be addressed at the meta-analysis level that cannot be addressed within individual studies. ⋯ The recommendations represent the views of the individual authors. We recognize that other approaches to data sharing that have been advocated are also based on sound ethical and scientific principles.
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Randomized Controlled Trial Comparative Study
Satisfying the needs of Japanese cancer patients: a comparative study of detailed and standard informed consent documents.
Simplified informed consent forms have been successful in improving patient satisfaction and decreasing patient anxiety. However, unsolved problems remain about whether these documents improve comprehension and satisfaction of patients with standard literacy skills. ⋯ Informed consent can be a significant experience for a population with standard literacy skills, as long as the document is easily comprehensible. Such information should be provided in a format that corresponds with patient needs, education levels, and preferences.
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Comparative Study
A phase I/II seamless dose escalation/expansion with adaptive randomization scheme (SEARS).
Standard drug development conducts phase I dose finding and phase II dose expansion sequentially and separately. Information between the two phases is rarely shared. Administratively, such a sequential process is time-consuming and burdensome. ⋯ We assume that the binary efficacy and toxicity response can be measured in the same time frame. This is often achievable with surrogate efficacy markers in practice.
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Observational Study
Understanding and retention of trial-related information among participants in a clinical trial after completing the informed consent process.
for assessing the level of understanding of trial-related information during the informed consent (IC) process in developing countries are lacking. ⋯ The ICAI may be adapted to an individual trial and may prove to be a useful tool following a consent discussion to identify issues not fully understood by the research participants, thus prompting study staff to re-explain topics, possibly in a more elementary manner.