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Interim Analysis
In clinical trials and other scientific studies, an interim analysis is an analysis of data that is conducted before data collection has been completed. Clinical trials are unusual in that enrollment of subjects is a continual process staggered in time. If a treatment can be proven to be clearly beneficial or harmful compared to the concurrent control, or to be obviously futile, based on a pre-defined analysis of an incomplete data set while the study is on-going, the investigators may stop the study early. Statistical methods The design of many clinical trials includes some strategy for early stopping if an interim analysis reveals large differences between treatment groups, or shows obvious futility such that there is no chance that continuing to the end would show a clinically meaningful effect. In addition to saving time and resources, such a design feature can reduce study participants' exposure to an inferior or useless treatment. However, when repeated significance testing o ... [...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 vary i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biometrika
''Biometrika'' is a peer-reviewed scientific journal published by Oxford University Press for thBiometrika Trust The editor-in-chief is Paul Fearnhead (Lancaster University). The principal focus of this journal is theoretical statistics. It was established in 1901 and originally appeared quarterly. It changed to three issues per year in 1977 but returned to quarterly publication in 1992. History ''Biometrika'' was established in 1901 by Francis Galton, Karl Pearson, and Raphael Weldon to promote the study of biometrics. The history of ''Biometrika'' is covered by Cox (2001). The name of the journal was chosen by Pearson, but Francis Edgeworth insisted that it be spelt with a "k" and not a "c". Since the 1930s, it has been a journal for statistical theory and methodology. Galton's role in the journal was essentially that of a patron and the journal was run by Pearson and Weldon and after Weldon's death in 1906 by Pearson alone until he died in 1936. In the early days, the American ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biometrics (journal)
''Biometrics'' is a journal that publishes articles on the application of statistics and mathematics to the biological sciences. It is published by the International Biometric Society (IBS).Biometrics homepage Originally published in 1945 under the title ''Biometrics Bulletin'', the journal adopted the shorter title in 1947. Biometrics, Vol. 3, No. 1, Mar., 1947 Page 53 /ref> A notable contributor to the journal was , for whom a memorial edition was published in 1964. [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Sequential Analysis
In statistics, sequential analysis or sequential hypothesis testing is statistical analysis where the sample size is not fixed in advance. Instead data are evaluated as they are collected, and further sampling is stopped in accordance with a pre-defined stopping rule as soon as significant results are observed. Thus a conclusion may sometimes be reached at a much earlier stage than would be possible with more classical hypothesis testing or estimation, at consequently lower financial and/or human cost. History The method of sequential analysis is first attributed to Abraham Wald with Jacob Wolfowitz, W. Allen Wallis, and Milton Friedman while at Columbia University's Statistical Research Group as a tool for more efficient industrial quality control during World War II. Its value to the war effort was immediately recognised, and led to its receiving a "restricted" classification. At the same time, George Barnard led a group working on optimal stopping in Great Britain. Ano ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Multicenter Automatic Defibrillator Implantation Trial
Multicenter Automatic Defibrillator Implantation Trial and MADIT II are implantable cardioverter defibrillator (or ICD) trials which investigate whether prophylactic ICD therapy in moderately high-risk coronary patients (in addition to conventional therapy) would significantly reduce death compared with patients treated with conventional therapy alone. The MADIT II trial started in 1997 and ended in 2001 where the safety committee stopped the study because the benefits were already statistically significant. The study included patients with a prior myocardial infarction and an ejection fraction An ejection fraction (EF) is the volumetric fraction (or portion of the total) of fluid (usually blood) ejected from a chamber (usually the heart) with each contraction (or heartbeat). It can refer to the cardiac atrium, ventricle, gall bladder, ... less than or equal to 30%. The results were a reduction in mortality of 31% compared to patients receiving conventional therapy alone. R ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Implantable Cardioverter-defibrillator
An implantable cardioverter-defibrillator (ICD) or automated implantable cardioverter defibrillator (AICD) is a device implantable inside the body, able to perform defibrillation, and depending on the type, cardioversion and pacing of the heart. The ICD is the first-line treatment and prophylactic therapy for patients at risk for sudden cardiac death due to ventricular fibrillation and ventricular tachycardia. "AICD" was trademarked by the Boston Scientific corporation, so the more generic "ICD" is preferred terminology. Current device batteries last about six to ten years; with advances in technology (batteries with more capacity or potentially rechargeable batteries) it may be possible to increase this well past ten years. The lead (the electrical cable connecting the device to the heart) has a much longer average longevity but can incur various types of malfunction, specifically insulation failure or fracture of the conductor, and require replacement. The process o ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Amiodarone
Amiodarone is an antiarrhythmic medication used to treat and prevent a number of types of cardiac dysrhythmias. This includes ventricular tachycardia (VT), ventricular fibrillation (VF), and wide complex tachycardia, as well as atrial fibrillation and paroxysmal supraventricular tachycardia. Evidence in cardiac arrest, however, is poor. It can be given by mouth, intravenously, or intraosseously. When used by mouth, it can take a few weeks for effects to begin. Common side effects include feeling tired, tremor, nausea, and constipation. As amiodarone can have serious side effects, it is mainly recommended only for significant ventricular arrhythmias. Serious side effects include lung toxicity such as interstitial pneumonitis, liver problems, heart arrhythmias, vision problems, thyroid problems, and death. If taken during pregnancy or breastfeeding it can cause problems in the fetus. It is a class III antiarrhythmic medication. It works partly by increasing the time before a he ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Sotalol
Sotalol, sold under the brand name Betapace among others, is a medication used to treat and prevent abnormal heart rhythms. It is only recommended in those with significant abnormal heart rhythms due to potentially serious side effects. Evidence does not support a decreased risk of death with long term use. It is taken by mouth or injection into a vein. Common side effects include a slow heart rate, chest pain, low blood pressure, feeling tired, dizziness, shortness of breath, problems seeing, vomiting, and swelling. Other serious side effects may include QT prolongation, heart failure, or bronchospasm. Sotalol is a non-selective beta-adrenergic receptor blocker which has both class II and class III antiarrhythmic properties. Sotalol was first described in 1964 and came into medical use in 1974. It is available as a generic medication. In 2020, it was the 296th most commonly prescribed medication in the United States, with more than 1million prescriptions. Medical uses Acc ... [...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] |
Medical Statistics
Medical statistics deals with applications of statistics to medicine and the health sciences, including epidemiology, public health, forensic medicine, and clinical research. Medical statistics has been a recognized branch of statistics in the United Kingdom for more than 40 years but the term has not come into general use in North America, where the wider term 'biostatistics' is more commonly used.Dodge, Y. (2003) ''The Oxford Dictionary of Statistical Terms'', OUP. However, "biostatistics" more commonly connotes all applications of statistics to biology. Medical statistics is a subdiscipline of statistics. "It is the science of summarizing, collecting, presenting and interpreting data in medical practice, and using them to estimate the magnitude of associations and test hypotheses. It has a central role in medical investigations. It not only provides a way of organizing information on a wider and more formal basis than relying on the exchange of anecdotes and personal experien ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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