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This study focuses on strategies and statistical considerations for assessment of translation in language (e.g. translation of case report forms in multinational clinical trials), information (e.g. translation of basic discoveries to the clinic) and technology (e.g. translation of Chinese diagnostic techniques to well-established clinical study end...
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Context 1
... an example, consider a clinical trial for evaluation of possible weight reduction of a test treatment in female patients. Weight data from 10 subjects are given in Table 1. As seen in Table 1 from pretreatment are 5.3 lbs and 4.8%, respec- tively. ...
Context 2
... data from 10 subjects are given in Table 1. As seen in Table 1 from pretreatment are 5.3 lbs and 4.8%, respec- tively. If a subject is considered a responder if there is weight reduction of > 5 lbs (absolute change) or > 5% (relative change), the response rates based on absolute and relative change are given as 40% and 30%, respectively. ...
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In recent years, the use of adaptive design methods in pharmaceutical/clinical research and development has become popular due to its flexibility and efficiency for identifying potential signals of clinical benefit of the test treatment under investigation. The flexibility and efficiency, however, increase the risk of operational biases with result...
Adaptive, seamless, multi-sponsor, multi-therapy platform clinical trials, designs executed on a large scale could create superior evidence more efficiently than single- sponsor, single- drug trials. Extending these adaptive platform trials also could diminish barriers to trial participation, increase the representation of real-world populations, a...
Citations
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Recently, translational research (TR) in health technology (HT) has been considered as an emerging alternative research system for the improvement of human health. TR from bench to bedside involves a strong bidirectional relationship between basic science discovery and clinical practice. To support R&D planning and policy in HT effectively, the performance of TR programs was analyzed and evaluated in a R&D project on health and medical technology. TR programs were classified into three parts: unilateral TR, bilateral TR and multilateral TR. Bibliometrics and citation analysis were performed to assess research papers and gather information for the performance analysis of TR programs. In addition, both quantitative and qualitative analysis were successfully carried out using ISI Web of Science, Google Scholar Citations, SCOPUS and Knowledgematrix. In conclusion, the performance analysis of TR programs could significantly improve the efficiency of R&D plans, R&D management and evaluation for a safe and healthy life.
The rapid emergence of translational developmental neuroscience as the key driver in understanding the onset of mental illness, the restructuring of academic health science centers on the NIH Roadmap, and dramatic shifts in drug, biological, device, and psychosocial intervention development all have important consequences for pediatric anxiety disorders as a field.
This article, which tracks the final presentation at a day-long symposium on pediatric anxiety disorders at the 2010 annual meeting of the Anxiety Disorders Association of America (ADAA), will try to outline where the field will head over the next decade as these forces combine to shape research and practice.
After 20 years of large comparative treatment trials that have defined the place of current generation treatments, the field is shifting toward interventions that will emerge from the revolution in translational developmental neuroscience and that herald the dawn of stratified and ultimately personalized medicine. With a much more efficient discovery to translational continuum, intervention development and dissemination will benefit from the concurrent transformation of the clinical and clinical research enterprise.
Dramatic advances in science and changes in the structure of medicine will condition the future of clinical research across every therapeutic area in medicine. For the field of pediatric anxiety disorders to thrive it will be important to embrace and actively participate in this revolution so that anxious youth are viewed as a key target population and, consequently, preemptive, preventive, and curative interventions will be developed for children by first intent.
This review considers the use of antiretroviral drugs specifically to prevent HIV transmission. Antiretroviral therapy (ART) can be implemented for the protection of uninfected individuals both before (preexposure prophylaxis) and after (postexposure prophylaxis) exposure to HIV infection. Preexposure prophylaxis may be used coitally dependently when individuals are intermittently exposed or by continuous daily dosing for those constantly exposed; postexposure prophylaxis is used in 28-day courses. Alternatively, ART can be used strategically to reduce the viral load and consequent infectiousness of an HIV-infected individual, thereby limiting the risk of onward viral transmission. A policy of universal HIV testing to enhance the identification of all HIV-positive individuals followed by immediate treatment of all HIV-positive individuals, irrespective of their CD4 cell counts (universal test and treat), has been postulated as a potential tool capable of reducing HIV incidence at a population level. This concept represents a paradigm shift in the use of ART, targeting infectious individuals for prevention rather than protecting uninfected exposed populations. This strategy could have the advantage of preventing transmission and reducing HIV incidence at a population level, as well as delivering universal access to therapy for all people living with HIV and AIDS, potentially eliminating mother-to-child HIV transmission and limiting concomitant diseases such as tuberculosis. This review critically examines the scientific basis of ART for HIV prevention, summarizing the risks and opportunities of the potential expansion of ART for prevention. Specifically, we consider the evidences for and against targeting HIV-uninfected individuals compared with enhanced HIV testing and treatment of HIV-infected individuals in terms of impact on viral transmission.
