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Outcome Switching
Outcome switching is the practice of changing the primary or secondary outcomes of a clinical trial after its initiation. An outcome is the goal of the clinical trial, such as survival after five years for cancer treatment. Outcome switching can lead to bias and undermine the reliability of the trial, for instance when outcomes are switched after researchers already have access to trial data. That way, researchers can cherry pick an outcome which is statistically significant. Problem Outcome switching can undermine the reliability of the trial, for instance when outcomes are switched when researchers already have access to the trial data. It can lead to bias in terms of benefits and harms. For example, when the findings using the original protocol were statistically insignificant, a study may cherry pick a new outcome measure that is statistically significant. If there are a large number of outcomes to choose from, it is likely at least one will show significant findings, assu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Outcome Measure
An outcome measure, endpoint, effect measure or measure of effect is a measure within medical practice or research, (primarily clinical trials) which is used to assess the effect, both positive and negative, of an intervention or treatment. Measures can often be quantified using effect sizes. Outcomes measures can be Patient-reported outcome, patient-reported, or gathered through laboratory tests such as Blood test, blood work, Clinical urine tests, urine samples etc. or through Physical examination, medical examination. Outcomes measures should be relevant to the target of the intervention (be it a single person or a target population). Depending on the design of a trial, outcome measures can be either primary outcomes, in which case the trial is designed around finding an adequate study size (through proper Random assignment, randomization and Statistical power, power calculation). Secondary or tertiary outcomes are outcome measures which are added after the design of the study is ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Ad Hominem
''Ad hominem'' (), short for ''argumentum ad hominem'' (), refers to several types of arguments, most of which are fallacious. Typically, this term refers to a rhetorical strategy where the speaker attacks the character, motive, or some other attribute of the person making an argument rather than addressing the substance of the argument itself. The most common form of ''ad hominem'' is "A makes a claim ''x'', B asserts that A holds a property that is unwelcome, and hence B concludes that argument ''x'' is wrong". Fallacious ''ad hominem'' reasoning occurs where the validity of an argument is not based on deduction or syllogism, but on an attribute of the person putting it forward. Valid ''ad hominem'' arguments occur in informal logic, where the person making the argument relies on arguments from authority such as testimony, expertise, or a selective presentation of information supporting the position they are advocating. In this case, counterarguments may be made that ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Research
Medical research (or biomedical research), also known as experimental medicine, encompasses a wide array of research, extending from "basic research" (also called ''bench science'' or ''bench research''), – involving fundamental scientific principles that may apply to a ''preclinical'' understanding – to clinical research, which involves studies of people who may be subjects in clinical trials. Within this spectrum is applied research, or translational research, conducted to expand knowledge in the field of medicine. Both clinical and preclinical research phases exist in the pharmaceutical industry's drug development pipelines, where the clinical phase is denoted by the term ''clinical trial''. However, only part of the clinical or preclinical research is oriented towards a specific pharmaceutical purpose. The need for fundamental and mechanism-based understanding, diagnostics, medical devices, and non-pharmaceutical therapies means that pharmaceutical research i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Scientific Misconduct
Scientific misconduct is the violation of the standard codes of scholarly conduct and ethical behavior in the publication of professional scientific research. A '' Lancet'' review on ''Handling of Scientific Misconduct in Scandinavian countries'' provides the following sample definitions, reproduced in The COPE report 1999: * Danish definition: "Intention or gross negligence leading to fabrication of the scientific message or a false credit or emphasis given to a scientist" * Swedish definition: "Intention ldistortion of the research process by fabrication of data, text, hypothesis, or methods from another researcher's manuscript form or publication; or distortion of the research process in other ways." The consequences of scientific misconduct can be damaging for perpetrators and journal audience and for any individual who exposes it. In addition there are public health implications attached to the promotion of medical or other interventions based on false or fabricated resea ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biostatistics
Biostatistics (also known as biometry) are the development and application of statistical methods to a wide range of topics in biology. It encompasses the design of biological experiments, the collection and analysis of data from those experiments and the interpretation of the results. History Biostatistics and genetics Biostatistical modeling forms an important part of numerous modern biological theories. Genetics studies, since its beginning, used statistical concepts to understand observed experimental results. Some genetics scientists even contributed with statistical advances with the development of methods and tools. Gregor Mendel started the genetics studies investigating genetics segregation patterns in families of peas and used statistics to explain the collected data. In the early 1900s, after the rediscovery of Mendel's Mendelian inheritance work, there were gaps in understanding between genetics and evolutionary Darwinism. Francis Galton tried to expand Mendel's ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trials
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 vary i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Research Ethics
Clinical research ethics are the set of relevant ethics considered in the conduct of a clinical trial in the field of clinical research. It borrows from the broader fields of research ethics and medical ethics. Governance Most directly a local institutional review board oversees the clinical research ethics of any given clinical trial. The institutional review board understands and acts according to local and national law. Each countries national law is guided by international principles, such as the Belmont Report's directive that all study participants have a right to "respect for persons", "beneficence", and "justice" when participating in clinical research. Study participant rights Participants in clinical research have rights which they should expect, including the following: *right to informed consent *shared decision-making *privacy for research participants *return of results *right to withdraw Vulnerable populations There is a range of autonomy which study participants ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Research Ethics
Research is " creative and systematic work undertaken to increase the stock of knowledge". It involves the collection, organization and analysis of evidence to increase understanding of a topic, characterized by a particular attentiveness to controlling sources of bias and error. These activities are characterized by accounting and controlling for biases. A research project may be an expansion on past work in the field. To test the validity of instruments, procedures, or experiments, research may replicate elements of prior projects or the project as a whole. The primary purposes of basic research (as opposed to applied research) are documentation, discovery, interpretation, and the research and development (R&D) of methods and systems for the advancement of human knowledge. Approaches to research depend on epistemologies, which vary considerably both within and between humanities and sciences. There are several forms of research: scientific, humanities, artistic, econ ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Data Dredging
Data dredging (also known as data snooping or ''p''-hacking) is the misuse of data analysis to find patterns in data that can be presented as statistically significant, thus dramatically increasing and understating the risk of false positives. This is done by performing many statistical tests on the data and only reporting those that come back with significant results. The process of data dredging involves testing multiple hypotheses using a single data set by exhaustively searching—perhaps for combinations of variables that might show a correlation, and perhaps for groups of cases or observations that show differences in their mean or in their breakdown by some other variable. Conventional tests of statistical significance are based on the probability that a particular result would arise if chance alone were at work, and necessarily accept some risk of mistaken conclusions of a certain type (mistaken rejections of the null hypothesis). This level of risk is called the ''s ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Leemon McHenry
Leemon McHenry is a bioethicist and Emeritus Professor of Philosophy at California State University, Northridge, in the United States. He has taught philosophy at the University of Edinburgh, Old Dominion University, Davidson College, Central Michigan University, Wittenberg University and Loyola Marymount University, and has held visiting research positions at Johns Hopkins University, UCLA and at the Institute for Advanced Studies in the Humanities in the University of Edinburgh. His research interests center on medical ethics, metaphysics, and philosophy of science. Education McHenry received his doctorate from the University of Edinburgh, in Scotland, where he was Vans Dunlop Scholar in Logic and Metaphysics supervised by Professor Timothy L. S. Sprigge. He defended the thesis ''Experience and relations in the metaphysics of A.N. Whitehead and F.H. Bradley,'' in `1984 by external examiner, Professor Dorothy Emmet, Cambridge University. Writings Much of McHenry's philosophic ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Study 329
Study 329 was a clinical trial which was conducted in North America from 1994 to 1998 to study the efficacy of paroxetine, an SSRI anti-depressant, in treating 12- to 18-year-olds diagnosed with major depressive disorder. Led by Martin Keller, then professor of psychiatry at Brown University, and funded by the British pharmaceutical company SmithKline Beecham—known since 2000 as GlaxoSmithKline (GSK)—the study compared paroxetine with imipramine, a tricyclic antidepressant, and placebo (an inert pill). SmithKline Beecham had released paroxetine in 1991, marketing it as Paxil in North America and Seroxat in the UK. The drug attracted sales of $11.7 billion in the United States alone from 1997 to 2006, including $2.12 billion in 2002, the year before it lost its patent. Published in July 2001 in the ''Journal of the American Academy of Child and Adolescent Psychiatry'' (''JAACAP''), which listed Keller and 21 other researchers as co-authors, study 329 became controver ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Paroxetine
Paroxetine, sold under the brand names Paxil and Seroxat among others, is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is used to treat major depressive disorder, obsessive-compulsive disorder, panic disorder, social anxiety disorder, posttraumatic stress disorder, generalized anxiety disorder and premenstrual dysphoric disorder. It has also been used in the treatment of premature ejaculation and hot flashes due to menopause. It is taken by mouth. Common side effects include drowsiness, dry mouth, loss of appetite, sweating, trouble sleeping, and sexual dysfunction. Serious side effects may include suicidal thoughts in those under the age of 25, serotonin syndrome, and mania. While the rate of side effects appears similar compared to other SSRIs and SNRIs, antidepressant discontinuation syndromes may occur more often. Use in pregnancy is not recommended, while use during breastfeeding is relatively safe. It is believed to work by blocking th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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