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Adaptive Design (medicine)
In an adaptive design of a clinical trial, the parameters and conduct of the trial for a candidate approved drug, drug or vaccine may be changed based on an interim analysis. Adaptive design typically involves advanced statistics to interpret a clinical trial clinical endpoint, endpoint. This is in contrast to traditional single-arm (i.e. non-randomized) clinical trials or Randomized controlled trial, randomized clinical trials (RCTs) that are static in their protocol and do not modify any parameters until the trial is completed. The adaptation process takes place at certain points in the trial, prescribed in the trial protocol. Importantly, this trial protocol is set before the trial begins with the adaptation schedule and processes specified. Adaptions may include modifications to: dosage, sample size, drug undergoing trial, patient selection criteria and/or "cocktail" mix. The PANDA (A Practical Adaptive & Novel Designs and Analysis toolkit) provides not only a summary of diffe ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Schematic Block Diagram Of Adaptive (Pharmaceutical) Clinical Trial Design After PMID 29490655
A schematic, or schematic diagram, is a designed representation of the elements of a system using abstract, graphic symbols rather than realistic pictures. A schematic usually omits all details that are not relevant to the key information the schematic is intended to convey, and may include oversimplified elements in order to make this essential meaning easier to grasp, as well as additional organization of the information. For example, a subway map intended for passengers may represent a subway station with a dot. The dot is not intended to resemble the actual station at all but aims to give the viewer information without unnecessary visual clutter. A schematic diagram of a chemical process uses symbols in place of detailed representations of the vessels, piping, valves, pumps, and other equipment that compose the system, thus emphasizing the functions of the individual elements and the interconnections among them and suppresses their physical details. In an electronic circuit d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
World Health Organization
The World Health Organization (WHO) is a list of specialized agencies of the United Nations, specialized agency of the United Nations which coordinates responses to international public health issues and emergencies. It is headquartered in Geneva, Switzerland, and has 6 regional offices and 150 field offices worldwide. Only sovereign states are eligible to join, and it is the largest intergovernmental health organization at the international level. The WHO's purpose is to achieve the highest possible level of health for all the world's people, defining health as "a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity." The main functions of the World Health Organization include promoting the control of epidemic and endemic diseases; providing and improving the teaching and training in public health, the medical treatment of disease, and related matters; and promoting the establishment of international standards for biologic ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Bandit Problem
Banditry is a type of organized crime committed by outlaws typically involving the threat or use of violence. A person who engages in banditry is known as a bandit and primarily commits crimes such as extortion, robbery, kidnapping, and murder, either as an individual or in groups. Banditry is a vague concept of criminality and in modern usage can be synonymous with gangsterism, brigandage, marauding, terrorism, piracy, and thievery. Definitions The term ''bandit'' (introduced to English via Italian around 1776) originates with the early Germanic legal practice of outlawing criminals, termed ''*bamnan'' (English ban). The legal term in the Holy Roman Empire was ''Acht'' or '' Reichsacht'', translated as "Imperial ban". In modern Italian, the equivalent word "bandito" literally means banned or a banned person. The New English Dictionary on Historical Principles (NED) defined "bandit" in 1885 as "one who is proscribed or outlawed; hence, a lawless desperate marauder, a brigand ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Bayesian Inference
Bayesian inference ( or ) is a method of statistical inference in which Bayes' theorem is used to calculate a probability of a hypothesis, given prior evidence, and update it as more information becomes available. Fundamentally, Bayesian inference uses a prior distribution to estimate posterior probabilities. Bayesian inference is an important technique in statistics, and especially in mathematical statistics. Bayesian updating is particularly important in the dynamic analysis of a sequence of data. Bayesian inference has found application in a wide range of activities, including science, engineering, philosophy, medicine, sport, and law. In the philosophy of decision theory, Bayesian inference is closely related to subjective probability, often called "Bayesian probability". Introduction to Bayes' rule Formal explanation Bayesian inference derives the posterior probability as a consequence of two antecedents: a prior probability and a "likelihood function" derive ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Alzheimer's Disease
Alzheimer's disease (AD) is a neurodegenerative disease and the cause of 60–70% of cases of dementia. The most common early symptom is difficulty in remembering recent events. As the disease advances, symptoms can include problems with language, disorientation (including easily getting lost), mood swings, loss of motivation, self-neglect, and behavioral issues. As a person's condition declines, they often withdraw from family and society. Gradually, bodily functions are lost, ultimately leading to death. Although the speed of progression can vary, the average life expectancy following diagnosis is three to twelve years. The causes of Alzheimer's disease remain poorly understood. There are many environmental and genetic risk factors associated with its development. The strongest genetic risk factor is from an allele of apolipoprotein E. Other risk factors include a history of head injury, clinical depression, and high blood pressure. The progression of the di ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Innovative Medicines Initiative
The Innovative Medicines Initiative (IMI) is a European initiative to improve the competitive situation of the European Union in the field of pharmaceutical research. The IMI is a joint initiative ( public-private partnership) of the DG Research of the European Commission, representing the European Communities, and the European Federation of Pharmaceutical Industries and Associations (EFPIA). IMI is laid out as a Joint Technology Initiative within the Seventh Framework Programme. Michel Goldman was the first executive director, from September 2009 until December 2014. The Innovative Medicines Initiative is aimed towards removing research bottlenecks in the current drug development process. The IMI Joint Technology Initiative (IMI JTI), to be implemented by the IMI Joint Undertaking is meant to address these research bottlenecks. Its €2bn budget makes it the largest biomedical public-private partnership in the world. The funding scheme has been criticised, requiring univers ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Accelerated Approval
The United States Food and Drug Administration (FDA) initiated the FDA Accelerated Approval Program in 1992 to allow faster approval of drugs for serious conditions that fill an unmet medical need. The faster approval relies on use of surrogate endpoints. Drug approval typically requires clinical trials with endpoints that demonstrate a clinical benefit, such as increased survival for cancer patients. Drugs with accelerated approval can initially be tested in clinical trials that use a surrogate endpoint, or something that is thought to predict clinical benefit. Surrogate endpoints typically require less time, and in the case of a cancer patient, it is much faster to measure a reduction in tumor size, for example, than overall patient survival. Drugs approved under the FDA Accelerated Approval Program still need to be tested in clinical trials using endpoints that demonstrate clinical benefit, and those trials are known as phase 4 confirmatory trials. If the drug later proves unabl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Neoadjuvant Therapy
Neoadjuvant therapy is the administration of therapeutic agents before a main treatment. One example is neoadjuvant hormone therapy prior to radical radiotherapy for adenocarcinoma of the prostate. Neoadjuvant therapy aims to reduce the size or extent of the cancer before using radical treatment intervention, thus both making procedures easier and more likely to succeed and reducing the consequences of a more extensive treatment technique, which would be required if the tumor were not reduced in size or extent. Another related concept is that neoadjuvant therapy acts on micrometastatic disease. The downstaging is then a surrogate marker of efficacy on undetected dissemination, resulting in improved longtime survival compared to the surgery-alone strategy. This systemic therapy (chemotherapy, immunotherapy or hormone therapy) or radiation therapy is commonly used in cancers that are locally advanced, and clinicians plan an operation at a later stage, such as pancreatic cancer ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
I-Spy 2
The I-SPY books are spotters' guides written for British children, particularly successful in the 1950s and 1960s in their original form and again when relaunched by Michelin in 2009 after a seven-year gap in publishing. A search engine set to look for images, with the words - "i-spy" News Chronicle Daily Mail Michelin, can illustrate that a range of styles was used. Concept The I-SPY books are a series of around forty small volumes that have sold hundreds of thousands of copies each, totalling sales of 25 million worldwide by 2010. Each book in the ''I-Spy'' series covers a different subject, such as ''I-SPY Cars'', ''I-SPY on the Pavement'', ''I-SPY Churches'', ''I-SPY on a Train Journey'', and so on. As children spot the objects listed, they record the event in the book and gain points, varying according to how unusual the sight. In the early years of the series, completed books could be sent to Charles Warrell, (known as Big Chief I-SPY) for a feather and order of merit. T ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Breast Cancer
Breast cancer is a cancer that develops from breast tissue. Signs of breast cancer may include a Breast lump, lump in the breast, a change in breast shape, dimpling of the skin, Milk-rejection sign, milk rejection, fluid coming from the nipple, a newly inverted nipple, or a red or scaly patch of skin. In those with Metastatic breast cancer, distant spread of the disease, there may be bone pain, swollen lymph nodes, shortness of breath, or yellow skin. Risk factors for developing breast cancer include obesity, a Sedentary lifestyle, lack of physical exercise, alcohol consumption, hormone replacement therapy during menopause, ionizing radiation, an early age at Menarche, first menstruation, having children late in life (or not at all), older age, having a prior history of breast cancer, and a family history of breast cancer. About five to ten percent of cases are the result of an inherited genetic predisposition, including BRCA mutation, ''BRCA'' mutations among others. Breast ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
National Institute Of Allergy And Infectious Diseases
The National Institute of Allergy and Infectious Diseases (NIAID, ) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services. NIAID's mission is to conduct Basic research, basic and applied research to better understand, treat, and prevent Infectious disease, infectious, Immune disorder, immunologic, and Allergy, allergic diseases. NIAID has on-campus Laboratory, laboratories in Maryland and Hamilton, Montana, and funds research conducted by scientists at institutions in the United States and throughout the world. NIAID also works closely with partners in academia, industry, government, and non-governmental organizations in multifaceted and multidisciplinary efforts to address emerging health challenges such as the Pandemic H1N1/09 virus, H1N1/09 pandemic and the COVID-19 pandemic. History NIAID traces its origins to a small laboratory established in 1887 at the Marine H ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Solidarity Trial
The Solidarity trial for treatments is a multinational Phase III-IV clinical trial organized by the World Health Organization (WHO) and partners to compare four untested treatments for hospitalized people with severe COVID-19 illness. The trial was announced 18 March 2020, and as of 6 August 2021, 12,000 patients in 30 countries had been recruited to participate in the trial. In May, the WHO announced an international coalition for simultaneously developing several candidate vaccines to prevent COVID-19 disease, calling this effort the Solidarity trial for vaccines. The treatments being investigated are remdesivir, lopinavir/ritonavir combined, lopinavir/ritonavir combined with interferon-beta, and hydroxychloroquine or chloroquine. Hydroxychloroquine or chloroquine investigation was discontinued in June 2020 due to concluding that it provided no benefit. Solidarity trial for treatment candidates The trial intends to rapidly assess thousands of COVID-19 infected people for t ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
