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Platform Trial
A platform trial is a type of prospective, disease-focused, adaptive, randomized clinical trial (RCT) that compares multiple, simultaneous and possibly differently-timed interventions against a single, constant control group. As a disease-focused trial design (compared to an intervention-focused), platform trials attempt to answer the question "which therapy will best treat this disease". Platform trials are unique in their utilization of both: a common control group and their opportunity to alter the therapies it investigates during its active enrollment phase. Platform trials commonly take advantage of Bayesian statistics, but may incorporate elements of frequentist statistics and/or machine learning. Purpose Platform trials can be a particularly useful design when researchers predict that multiple therapies that would become available at different times require investigation. For example, when the COVID-19 pandemic began, researchers predicted that there would eventually be mu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Adaptive Clinical Trial
In an adaptive design of a clinical trial, the parameters and conduct of the trial for a candidate drug or vaccine may be changed based on an interim analysis. Adaptive design typically involves advanced statistics to interpret a clinical trial endpoint. This is in contrast to traditional single-arm (i.e. non-randomized) clinical trials or 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 different adaptive designs, but also comprehensive information on ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, pharmaceutical drug, drugs, medical nutrition therapy, 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 institutional review board, 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 experiment, pi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Treatment And Control Groups
In the design of experiments, hypotheses are applied to experimental units in a treatment group. In comparative experiments, members of a control group receive a standard treatment, a placebo, or no treatment at all. There may be more than one treatment group, more than one control group, or both. A placebo control group can be used to support a double-blind study, in which some subjects are given an ineffective treatment (in medical studies typically a sugar pill) to minimize differences in the experiences of subjects in the different groups; this is done in a way that ensures no participant in the experiment (subject or experimenter) knows to which group each subject belongs. In such cases, a third, non-treatment control group can be used to measure the placebo effect directly, as the difference between the responses of placebo subjects and untreated subjects, perhaps paired by age group or other factors (such as being twins). For the conclusions drawn from the results of an ... [...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] |
Frequentist Inference
Frequentist inference is a type of statistical inference based in frequentist probability, which treats “probability” in equivalent terms to “frequency” and draws conclusions from sample-data by means of emphasizing the frequency or proportion of findings in the data. Frequentist inference underlies frequentist statistics, in which the well-established methodologies of statistical hypothesis testing and confidence intervals are founded. History of frequentist statistics Frequentism is based on the presumption that statistics represent probabilistic frequencies. This view was primarily developed by Ronald Fisher and the team of Jerzy Neyman and Egon Pearson. Ronald Fisher contributed to frequentist statistics by developing the frequentist concept of "significance testing", which is the study of the significance of a measure of a statistic when compared to the hypothesis. Neyman-Pearson extended Fisher's ideas to apply to multiple hypotheses. They posed that the rati ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Machine Learning
Machine learning (ML) is a field of study in artificial intelligence concerned with the development and study of Computational statistics, statistical algorithms that can learn from data and generalise to unseen data, and thus perform Task (computing), tasks without explicit Machine code, instructions. Within a subdiscipline in machine learning, advances in the field of deep learning have allowed Neural network (machine learning), neural networks, a class of statistical algorithms, to surpass many previous machine learning approaches in performance. ML finds application in many fields, including natural language processing, computer vision, speech recognition, email filtering, agriculture, and medicine. The application of ML to business problems is known as predictive analytics. Statistics and mathematical optimisation (mathematical programming) methods comprise the foundations of machine learning. Data mining is a related field of study, focusing on exploratory data analysi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
COVID-19 Pandemic
The COVID-19 pandemic (also known as the coronavirus pandemic and COVID pandemic), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), began with an disease outbreak, outbreak of COVID-19 in Wuhan, China, in December 2019. Soon after, it spread to other areas of Asia, and COVID-19 pandemic by country and territory, then worldwide in early 2020. The World Health Organization (WHO) declared the outbreak a public health emergency of international concern (PHEIC) on 30 January 2020, and assessed the outbreak as having become a pandemic on 11 March. COVID-19 symptoms range from asymptomatic to deadly, but most commonly include fever, sore throat, nocturnal cough, and fatigue. Transmission of COVID-19, Transmission of the virus is often airborne transmission, through airborne particles. Mutations have variants of SARS-CoV-2, produced many strains (variants) with varying degrees of infectivity and virulence. COVID-19 vaccines were developed rapidly and deplo ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Institutional Review Board
An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee at an institution that applies research ethics by reviewing the methods proposed for research involving human subjects, to ensure that the projects are ethical. The main goal of IRB reviews is to ensure that study participants are not harmed (or that harms are minimal and outweighed by research benefits). Such boards are formally designated to approve (or reject), monitor, and review biomedical and behavioral research involving humans, and they are legally required in some countries under certain specified circumstances. Most countries use some form of IRB to safeguard ethical conduct of research so that it complies with national and international norms, regulations or codes. The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of people participating in a research stu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Dunnett's Test
In statistics, Dunnett's test is a multiple comparison procedure developed by Canadian statistician Charles Dunnett to compare each of a number of treatments with a single control. Multiple comparisons to a control are also referred to as many-to-one comparisons. History Dunnett's test was developed in 1955; an updated table of critical values was published in 1964.Dunnett C. W. (1964.) "New tables for multiple comparisons with a control", ''Biometrics'', 20:482491. Multiple comparisons problem The multiple comparisons, multiplicity or multiple testing problem occurs when one considers a set of statistical inferences simultaneously or infers a subset of parameters selected based on the observed values. The major issue in any discussion of multiple-comparison procedures is the question of the probability of Type I errors. Most differences among alternative techniques result from different approaches to the question of how to control these errors. The problem is in part technical; ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Antibiotic
An antibiotic is a type of antimicrobial substance active against bacteria. It is the most important type of antibacterial agent for fighting pathogenic bacteria, bacterial infections, and antibiotic medications are widely used in the therapy, treatment and antibiotic prophylaxis, prevention of such infections. They may either bactericide, kill or bacteriostatic agent, inhibit the growth of bacteria. A limited number of antibiotics also possess antiprotozoal activity. Antibiotics are not effective against viruses such as the ones which cause the common cold or influenza. Drugs which inhibit growth of viruses are termed antiviral drugs or antivirals. Antibiotics are also not effective against fungi. Drugs which inhibit growth of fungi are called antifungal drugs. Sometimes, the term ''antibiotic''—literally "opposing life", from the Greek language, Greek roots ἀντι ''anti'', "against" and βίος ''bios'', "life"—is broadly used to refer to any substance used against ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Immunotherapy
Immunotherapy or biological therapy is the treatment of disease by activating or suppressing the immune system. Immunotherapies designed to elicit or amplify an immune response are classified as ''activation immunotherapies,'' while immunotherapies that reduce or suppress are classified as '' suppression immunotherapies''. Immunotherapy is under preliminary research for its potential to treat various forms of cancer. Cell-based immunotherapies are effective for some cancers. Immune effector cells such as lymphocytes, macrophages, dendritic cells, natural killer cells, and cytotoxic T lymphocytes work together to defend the body against cancer by targeting abnormal antigens expressed on the surface of tumor cells. Vaccine-induced immunity to COVID-19 relies mostly on an immunomodulatory T-cell response. Therapies such as granulocyte colony-stimulating factor (G-CSF), interferons, imiquimod and cellular membrane fractions from bacteria are licensed for medical use. Others in ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Standard Of Care
In tort law, the standard of care is the only degree of prudence and caution required of an individual who is under a duty of care. The requirements of the standard are closely dependent on circumstances. Whether the standard of care has been breached is determined by the trier of fact, and is usually phrased in terms of the reasonable person; this is sometimes labeled as the "reasonable physician standard". It was famously described in ''Vaughn v. Menlove'' (1837) as whether the individual "proceed[ed] with such reasonable caution as a prudent man would have exercised under such circumstances". Professional standard of care In certain industries and professions, the standard of care is determined by the standard that would be exercised by the reasonably prudent manufacturer of a product, or the reasonably prudent professional in that line of work. Such a test (known as the "Bolam Test") was used to determine whether a doctor was liable for medical malpractice before the 2015 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
