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Cytel
Cytel is a multinational statistical software developer and contract research organization, headquartered in Cambridge, Massachusetts, USA. Cytel provides clinical trial design, implementation services, and statistical products primarily for the biotech and pharmaceutical development markets. Cytel specializes in adaptive trials – a type of Randomized clinical trial, randomized clinical trial that allows modifications of ongoing trials while aiming to preserve the statistical validity and integrity of the study. Based on either Frequency probability, frequentist or Bayesian statistics, adaptive trial designs are now widely accepted by government regulatory agencies including the United States Food and Drug Administration (FDA), European Medicines Agency (EMA), and Medicines and Healthcare products Regulatory Agency (MHRA) in early and later stage clinical studies. As of January 2014, the company claims 25 large biopharmaceutical companies as users of its software to design, simu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Cambridge, Massachusetts
Cambridge ( ) is a city in Middlesex County, Massachusetts, United States. As part of the Boston metropolitan area, the cities population of the 2020 U.S. census was 118,403, making it the fourth most populous city in the state, behind Boston, Worcester, and Springfield. It is one of two de jure county seats of Middlesex County, although the county's executive government was abolished in 1997. Situated directly north of Boston, across the Charles River, it was named in honor of the University of Cambridge in England, once also an important center of the Puritan theology embraced by the town's founders. Harvard University, the Massachusetts Institute of Technology (MIT), Lesley University, and Hult International Business School are in Cambridge, as was Radcliffe College before it merged with Harvard. Kendall Square in Cambridge has been called "the most innovative square mile on the planet" owing to the high concentration of successful startups that have emerged in the vicinity ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
CDISC Migration
The Clinical Data Interchange Standards Consortium (CDISC) is a standards developing organization (SDO) dealing with medical research data linked with healthcare, to "enable information system interoperability to improve medical research and related areas of healthcare". The standards support medical research from protocol through analysis and reporting of results and have been shown to decrease resources needed by 60% overall and 70–90% in the start-up stages when they are implemented at the beginning of the research process. CDISC standards are harmonized through a model that is also a HL7 standard and is the process to becoming an ISO/ CEN standard. History * Late 1997 – Started as a Volunteer group * Summer 1998 – Invited to form DIA SIAC * 1999 – SDS v1.0; ODM v0.8 * 2000 – SDS v1.1 * Feb 2000 – Formed an Independent, non-profit organization * Dec 2001 – Global participation * 2001 – SDS v2.0; ODM v1.0 * 2002 – ODM v1.1; ADaM v1.0 * 2003 – LAB v1.0; SDTM ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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] |
Logistic Regression
In statistics, the logistic model (or logit model) is a statistical model that models the probability of an event taking place by having the log-odds for the event be a linear function (calculus), linear combination of one or more independent variables. In regression analysis, logistic regression (or logit regression) is estimation theory, estimating the parameters of a logistic model (the coefficients in the linear combination). Formally, in binary logistic regression there is a single binary variable, binary dependent variable, coded by an indicator variable, where the two values are labeled "0" and "1", while the independent variables can each be a binary variable (two classes, coded by an indicator variable) or a continuous variable (any real value). The corresponding probability of the value labeled "1" can vary between 0 (certainly the value "0") and 1 (certainly the value "1"), hence the labeling; the function that converts log-odds to probability is the logistic function, h ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
SAS System
SAS (previously "Statistical Analysis System") is a statistical software suite developed by SAS Institute for data management, advanced analytics, multivariate analysis, business intelligence, criminal investigation, and predictive analytics. SAS was developed at North Carolina State University from 1966 until 1976, when SAS Institute was incorporated. SAS was further developed in the 1980s and 1990s with the addition of new statistical procedures, additional components and the introduction of JMP. A point-and-click interface was added in version 9 in 2004. A social media analytics product was added in 2010. Technical overview and terminology SAS is a software suite that can mine, alter, manage and retrieve data from a variety of sources and perform statistical analysis on it. SAS provides a graphical point-and-click user interface for non-technical users and more through the SAS language. SAS programs have DATA steps, which retrieve and manipulate data, and PROC steps, whic ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Non-parametric Statistics
Nonparametric statistics is the branch of statistics that is not based solely on parametrized families of probability distributions (common examples of parameters are the mean and variance). Nonparametric statistics is based on either being distribution-free or having a specified distribution but with the distribution's parameters unspecified. Nonparametric statistics includes both descriptive statistics and statistical inference. Nonparametric tests are often used when the assumptions of parametric tests are violated. Definitions The term "nonparametric statistics" has been imprecisely defined in the following two ways, among others: Applications and purpose Non-parametric methods are widely used for studying populations that take on a ranked order (such as movie reviews receiving one to four stars). The use of non-parametric methods may be necessary when data have a ranking but no clear numerical interpretation, such as when assessing preferences. In terms of levels of me ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Exact Statistics
Exact statistics, such as that described in exact test, is a branch of statistics that was developed to provide more accurate results pertaining to statistical testing and interval estimation by eliminating procedures based on asymptotic and approximate statistical methods. The main characteristic of exact methods is that statistical tests and confidence intervals are based on exact probability statements that are valid for any sample size. Exact statistical methods help avoid some of the unreasonable assumptions of traditional statistical methods, such as the assumption of equal variances in classical ANOVA. They also allow exact inference on variance components of mixed models. When exact ''p''-values and confidence intervals are computed under a certain distribution, such as the normal distribution, then the underlying methods are referred to as exact parametric methods. The exact methods that do not make any distributional assumptions are referred to as exact nonparametric meth ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
R (programming Language)
R is a programming language for statistical computing and graphics supported by the R Core Team and the R Foundation for Statistical Computing. Created by statisticians Ross Ihaka and Robert Gentleman, R is used among data miners, bioinformaticians and statisticians for data analysis and developing statistical software. Users have created packages to augment the functions of the R language. According to user surveys and studies of scholarly literature databases, R is one of the most commonly used programming languages used in data mining. R ranks 12th in the TIOBE index, a measure of programming language popularity, in which the language peaked in 8th place in August 2020. The official R software environment is an open-source free software environment within the GNU package, available under the GNU General Public License. It is written primarily in C, Fortran, and R itself (partially self-hosting). Precompiled executables are provided for various operating systems. R ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Bayesian Methods
Bayesian inference is a method of statistical inference in which Bayes' theorem is used to update the probability for a hypothesis as more evidence or information becomes available. Bayesian inference is an important technique in statistics, and especially in mathematical statistics. Bayesian updating is particularly important in the Sequential analysis, 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 relation, consequence of two Antecedent (logic), antecedents: a prior probability and a "likelihood function" derived from a statistical model for the observed data. Bayesian inference computes ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Dose-ranging Study
A dose-ranging study is a clinical trial where different doses of an agent (e.g. a drug) are tested against each other to establish which dose works best and/or is least harmful. Dose-ranging is usually a phase I or early phase II clinical trial. Typically a dose ranging study will include a placebo group of subjects, and a few groups that receive different doses of the test drug. For instance, a typical dose-ranging study may include four groups: a placebo group, low-dose group, medium-dose group and a high-dose group. The maximum tolerable dose (MTD) information is necessary to be able to design such groups and therefore dose-ranging studies are usually designed after the availability of MTD information. The main goal of a dose-ranging study is to estimate the response vs. dose given, so as to analyze the efficacy and safety Safety is the state of being "safe", the condition of being protected from harm or other danger. Safety can also refer to the control of recognized ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Feasibility Study
A feasibility study is an assessment of the practicality of a project or system. A feasibility study aims to objectively and rationally uncover the strengths and weaknesses of an existing business or proposed venture, opportunities and threats present in the natural environment, the resources required to carry through, and ultimately the prospects for success.Justis, R. T. & Kreigsmann, B. (1979). The feasibility study as a tool for venture analysis. ''Business Journal of Small Business Management'' 17 (1) 35-42. In its simplest terms, the two criteria to judge feasibility are cost required and value to be attained. A well-designed feasibility study should provide a historical background of the business or project, a description of the product or service, accounting statements, details of the operations and management, marketing research and policies, financial data, legal requirements and tax obligations. Generally, feasibility studies precede technical development and project ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Placebo-controlled Studies
Placebo-controlled studies are a way of testing a medical therapy in which, in addition to a group of subjects that receives the treatment to be evaluated, a separate control group receives a sham "placebo" treatment which is specifically designed to have no real effect. Placebos are most commonly used in blinded trials, where subjects do not know whether they are receiving real or placebo treatment. Often, there is also a further "natural history" group that does not receive any treatment at all. The purpose of the placebo group is to account for the placebo effect, that is, effects from treatment that do not depend on the treatment itself. Such factors include knowing one is receiving a treatment, attention from health care professionals, and the expectations of a treatment's effectiveness by those running the research study. Without a placebo group to compare against, it is not possible to know whether the treatment itself had any effect. Patients frequently show improvement e ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
