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Clinical Trials Unit
Clinical trials units (CTU) are specialised biomedical research units which design, centrally coordinate and analyse clinical trials and other studies. Some CTUs specialise in different methodologies, such as randomised controlled trials, cluster randomised trials, surgical trials, and health services research. Some specialise in one disease type, whereas others are generic units. Some CTUs focus on specific phases and types of clinical trials; others conduct all phases and types of trial. United Kingdom The UKCRC evaluates CTUs in the UK and they may be given either Full or Provisional CTU registration status. All Registered CTUs are required to provide evidence that their work is of high quality by demonstrating (1) experience of coordinating multi-centre randomised controlled trials or other well-designed studies, (2) a presence of a core team of expert staff to develop studies, (3) a presence of robust quality assurance systems and processes to meet appropriate regulations a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biomedical 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] |
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] |
Randomized Controlled Trial
A randomized controlled trial (or randomized control trial; RCT) is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures or other medical treatments. Participants who enroll in RCTs differ from one another in known and unknown ways that can influence study outcomes, and yet cannot be directly controlled. By Random assignment, randomly allocating participants among compared treatments, an RCT enables ''statistical control'' over these influences. Provided it is designed well, conducted properly, and enrolls enough participants, an RCT may achieve sufficient control over these confounding factors to deliver a useful comparison of the treatments studied. Definition and examples An RCT in clinical research typically compares a proposed new treatment against an existing Standard of care#Medical standard of care, ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Cluster Randomised Controlled Trial
A cluster-randomised controlled trial is a type of randomised controlled trial in which groups of subjects (as opposed to individual subjects) are randomised. Cluster randomised controlled trials are also known as cluster-randomised trials, group-randomised trials, and place-randomized trials. Cluster-randomised controlled trials are used when there is a strong reason for randomising treatment and control groups over randomising participants. Prevalence A 2004 Bibliometrics, bibliometric study documented an increasing number of publications in the medical literature on cluster-randomised controlled trials since the 1980s. Advantages Advantages of cluster-randomised controlled trials over individually randomised controlled trials include: * The ability to study interventions that cannot be directed toward selected individuals (e.g., a radio show about lifestyle changes) and the ability to control for "contamination" across individuals (e.g., one individual's changing behaviors may ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United Kingdom
The United Kingdom of Great Britain and Northern Ireland, commonly known as the United Kingdom (UK) or Britain, is a country in Europe, off the north-western coast of the continental mainland. It comprises England, Scotland, Wales and Northern Ireland. The United Kingdom includes the island of Great Britain, the north-eastern part of the island of Ireland, and many smaller islands within the British Isles. Northern Ireland shares a land border with the Republic of Ireland; otherwise, the United Kingdom is surrounded by the Atlantic Ocean, the North Sea, the English Channel, the Celtic Sea and the Irish Sea. The total area of the United Kingdom is , with an estimated 2020 population of more than 67 million people. The United Kingdom has evolved from a series of annexations, unions and separations of constituent countries over several hundred years. The Treaty of Union between the Kingdom of England (which included Wales, annexed in 1542) and the Kingdom of Scotland in 170 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medicines And Healthcare Products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe. The MHRA was formed in 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). In April 2013, it merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with the MHRA identity being used solely for the regulatory centre within the group. The agency employs more than 1,200 people in London, York and South Mimms, Hertfordshire. Structure The MHRA is divided into three main centres: * MHRA Regulatory – the regulator for the pharmaceutical and medical devices industries * Clinical Practice Research Datalink – licences anonymised health care data to pharmaceutical companies, academics and other regulators for research * National Institute for Biolog ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Multiple Organ Dysfunction Syndrome
Multiple organ dysfunction syndrome (MODS) is altered organ (anatomy), organ function in an acutely ill patient requiring medicine, medical intervention to achieve homeostasis. Although Irwin and Rippe cautioned in 2005 that the use of "multiple organ failure" or "multisystem organ failure" should be avoided, both Harrison's (2015) and Cecil's (2012) medical textbooks still use the terms "multi-organ failure" and "multiple organ failure" in several chapters and do not use "multiple organ dysfunction syndrome" at all. There are different stages of organ dysfunction for certain different organs, both in acute and in chronic onset, whether or not there are one or more organs affected. Each stage of dysfunction (whether it be the heart, lung, liver, or kidney) has defined parameters, in terms of laboratory values based on blood and other tests, as to what it is (each of these organs' levels of failure is divided into stage I, II, III, IV, and V). The word "failure" is commonly used t ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
TGN1412
Theralizumab (also known as TGN1412, CD28-SuperMAB, and TAB08) is an immunomodulatory drug developed by Thomas Hünig of the University of Würzburg. It was withdrawn from development after inducing severe inflammatory reactions as well as chronic organ failure in the first-in-human study by PAREXEL in London in March 2006. The developing company, TeGenero Immuno Therapeutics, went bankrupt later that year. The commercial rights were then acquired by a Russian startup, TheraMAB. The drug was renamed TAB08. Phase I and II clinical trials have been completed for arthritis and clinical trials have been initiated for cancer. Originally intended for the treatment of B cell chronic lymphocytic leukemia (B-CLL) and rheumatoid arthritis, TGN1412 is a humanised monoclonal antibody that not only binds to, but is a strong agonist for, the CD28 receptor of the immune system's T cells. CD28 is the co-receptor for the T cell receptor; It binds to receptors on the interacting partner in the ... [...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 States ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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