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Clinical Study Report
{{Short description, Document providing much detail about the methods and results of a trialIn medicine, a clinical study report (CSR) on a clinical trial is a document, typically very long, providing much detail about the methods and results of a trial. A CSR is a scientific document addressing efficacy and safety, not a sales or marketing tool; its content is similar to that of a peer-review Peer review is the evaluation of work by one or more people with similar competencies as the producers of the work ( peers). It functions as a form of self-regulation by qualified members of a profession within the relevant field. Peer revie ...ed academic paper. Results of trials are usually reported in a briefer academic journal paper, but methodological flaws are often glossed over in the briefer paper.Ben Goldacre">Ben Goldacre, Statins have no side effects? This is what our study really found …, Guardian newspaper, 15 March 2014/ref> The International Conference on Harmonisation ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medicine
Medicine is the science and practice of caring for a patient, managing the diagnosis, prognosis, prevention, treatment, palliation of their injury or disease, and promoting their health. Medicine encompasses a variety of health care practices evolved to maintain and restore health by the prevention and treatment of illness. Contemporary medicine applies biomedical sciences, biomedical research, genetics, and medical technology to diagnose, treat, and prevent injury and disease, typically through pharmaceuticals or surgery, but also through therapies as diverse as psychotherapy, external splints and traction, medical devices, biologics, and ionizing radiation, amongst others. Medicine has been practiced since prehistoric times, and for most of this time it was an art (an area of skill and knowledge), frequently having connections to the religious and philosophical beliefs of local culture. For example, a medicine man would apply herbs and say prayers fo ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can va ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Peer-review
Peer review is the evaluation of work by one or more people with similar competencies as the producers of the work ( peers). It functions as a form of self-regulation by qualified members of a profession within the relevant field. Peer review methods are used to maintain quality standards, improve performance, and provide credibility. In academia, scholarly peer review is often used to determine an academic paper's suitability for publication. Peer review can be categorized by the type of activity and by the field or profession in which the activity occurs, e.g., medical peer review. It can also be used as a teaching tool to help students improve writing assignments. Henry Oldenburg (1619–1677) was a German-born British philosopher who is seen as the 'father' of modern scientific peer review. Professional Professional peer review focuses on the performance of professionals, with a view to improving quality, upholding standards, or providing certification. In academia, ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Academic Publishing
Academic publishing is the subfield of publishing which distributes academic research and scholarship. Most academic work is published in academic journal articles, books or theses. The part of academic written output that is not formally published but merely printed up or posted on the Internet is often called "grey literature". Most scientific and scholarly journals, and many academic and scholarly books, though not all, are based on some form of peer review or editorial refereeing to qualify texts for publication. Peer review quality and selectivity standards vary greatly from journal to journal, publisher to publisher, and field to field. Most established academic disciplines have their own journals and other outlets for publication, although many academic journals are somewhat interdisciplinary, and publish work from several distinct fields or subfields. There is also a tendency for existing journals to divide into specialized sections as the field itself becomes more s ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Ben Goldacre
Ben Michael Goldacre (born 20 May 1974) is a British physician, academic and science writer. He is the first Bennett Professor of Evidence-Based Medicine and director of the Bennett Institute for Applied Data Science at the University of Oxford. He is a founder of the AllTrials campaign and OpenTrials to require open science practices in clinical trials. Goldacre is known in particular for his ''Bad Science'' column in ''The Guardian'', which he wrote between 2003 and 2011, and is the author of four books: '' Bad Science'' (2008), a critique of irrationality and certain forms of alternative medicine; ''Bad Pharma'' (2012), an examination of the pharmaceutical industry, its publishing and marketing practices, and its relationship with the medical profession; ''I Think You'll Find It's a Bit More Complicated Than That'', a collection of his journalism; and ''Statins'', about evidence-based medicine. Goldacre frequently delivers free talks about bad science; he describes himself ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical Guidelines and requirements for pharmaceutical product registration. Harmonisation leads to a more rational use of human, animal and other resources, the elimination of unnecessary delay in the global development, and availability of new medicines while maintaining safeguards on quality, safety, efficacy, and regulatory obligations to protect public health. Junod notes in her 2005 treatise on Clinical Drug Trials that "Above all, the ICH has succeeded in aligning clinical trial requirements." History In the 1980s the European Union began harmonising regulatory requirem ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Research
Clinical research is a branch of healthcare science that determines the safety and effectiveness ( efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment. Overview The term "clinical research" refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied. In the United State ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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