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Probability Of Success
The probability of success (POS) is a statistics concept commonly used in the pharmaceutical industry including by health authorities to support decision making. The probability of success is a concept closely related to conditional power and predictive power. Conditional power is the probability of observing statistical significance given the observed data assuming the treatment effect parameter equals a specific value. Conditional power is often criticized for this assumption. If we know the exact value of the treatment effect, there is no need to do the experiment. To address this issue, we can consider conditional power in a Bayesian setting by considering the treatment effect parameter to be a random variable. Taking the expected value of the conditional power with respect to the posterior distribution of the parameter gives the predictive power. Predictive power can also be calculated in a frequentist setting. No matter how it is calculated, predictive power is a random va ...
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Success (concept)
Success is the state or condition of meeting a Definition, defined range of Expectation (epistemic), expectations. It may be viewed as the opposite of failure. The criteria for success depend on context, and may be relative to a particular observer or belief system. One person might consider a success what another person considers a failure, particularly in cases of direct competition or a Zero sum, zero-sum game. Similarly, the degree of success or failure in a situation may be differently viewed by distinct observers or participants, such that a situation that one considers to be a success, another might consider to be a failure, a qualified success or a neutral situation. For example, a film that is a commercial failure or even a box-office bomb can go on to receive a cult following, with the initial lack of commercial success even lending a cachet of subcultural Cool (aesthetic), coolness. It may also be difficult or impossible to ascertain whether a situation meets criteria ...
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Predictive Probability Of Success
Predictive probability of success (PPOS) is a statistics concept commonly used in the pharmaceutical industry including by health authorities to support decision making. In clinical trials, PPOS is the probability of observing a success in the future based on existing data. It is one type of probability of success. A Bayesian means by which the PPOS can be determined is through integrating the data's likelihood over possible future responses (posterior distribution). Types of PPOS * Classification based on type of end point: Normal, binary, time to event. * Classification based on the relationship between the trial providing data and the trial to be predicted # Cross trial PPOS: using data from one trial to predict the other trial # Within trial PPOS: using data at interim analysis to predict the same trial at final analysis * Classification based on the relationship between the end point(s) with data and the end point to be predicted # 1 to 1 PPOS: using one end point to predict ...
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Credible Interval
In Bayesian statistics, a credible interval is an interval used to characterize a probability distribution. It is defined such that an unobserved parameter value has a particular probability \gamma to fall within it. For example, in an experiment that determines the distribution of possible values of the parameter \mu, if the probability that \mu lies between 35 and 45 is \gamma=0.95, then 35 \le \mu \le 45 is a 95% credible interval. Credible intervals are typically used to characterize posterior probability distributions or predictive probability distributions. Their generalization to disconnected or multivariate sets is called credible set or credible region. Credible intervals are a Bayesian analog to confidence intervals in frequentist statistics. The two concepts arise from different philosophies: Bayesian intervals treat their bounds as fixed and the estimated parameter as a random variable, whereas frequentist confidence intervals treat their bounds as random varia ...
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False Positive
A false positive is an error in binary classification in which a test result incorrectly indicates the presence of a condition (such as a disease when the disease is not present), while a false negative is the opposite error, where the test result incorrectly indicates the absence of a condition when it is actually present. These are the two kinds of errors in a binary test, in contrast to the two kinds of correct result (a and a ). They are also known in medicine as a false positive (or false negative) diagnosis, and in statistical classification as a false positive (or false negative) error. In statistical hypothesis testing, the analogous concepts are known as type I and type II errors, where a positive result corresponds to rejecting the null hypothesis, and a negative result corresponds to not rejecting the null hypothesis. The terms are often used interchangeably, but there are differences in detail and interpretation due to the differences between medical testing and sta ...
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Optimal Design
In the design of experiments, optimal experimental designs (or optimum designs) are a class of experimental designs that are optimal with respect to some statistical criterion. The creation of this field of statistics has been credited to Danish statistician Kirstine Smith. In the design of experiments for estimating statistical models, optimal designs allow parameters to be estimated without bias and with minimum variance. A non-optimal design requires a greater number of experimental runs to estimate the parameters with the same precision as an optimal design. In practical terms, optimal experiments can reduce the costs of experimentation. The optimality of a design depends on the statistical model and is assessed with respect to a statistical criterion, which is related to the variance-matrix of the estimator. Specifying an appropriate model and specifying a suitable criterion function both require understanding of statistical theory and practical knowledge with ...
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Type I Error
Type I error, or a false positive, is the erroneous rejection of a true null hypothesis in statistical hypothesis testing. A type II error, or a false negative, is the erroneous failure in bringing about appropriate rejection of a false null hypothesis. Type I errors can be thought of as errors of commission, in which the status quo is erroneously rejected in favour of new, misleading information. Type II errors can be thought of as errors of omission, in which a misleading status quo is allowed to remain due to failures in identifying it as such. For example, if the assumption that people are ''innocent until proven guilty'' were taken as a null hypothesis, then proving an innocent person as guilty would constitute a Type I error, while failing to prove a guilty person as guilty would constitute a Type II error. If the null hypothesis were inverted, such that people were by default presumed to be ''guilty until proven innocent'', then proving a guilty person's innocence would ...
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Posterior Probability
The posterior probability is a type of conditional probability that results from updating the prior probability with information summarized by the likelihood via an application of Bayes' rule. From an epistemological perspective, the posterior probability contains everything there is to know about an uncertain proposition (such as a scientific hypothesis, or parameter values), given prior knowledge and a mathematical model describing the observations available at a particular time. After the arrival of new information, the current posterior probability may serve as the prior in another round of Bayesian updating. In the context of Bayesian statistics, the posterior probability distribution usually describes the epistemic uncertainty about statistical parameters conditional on a collection of observed data. From a given posterior distribution, various point and interval estimates can be derived, such as the maximum a posteriori (MAP) or the highest posterior density int ...
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Statistical Significance
In statistical hypothesis testing, a result has statistical significance when a result at least as "extreme" would be very infrequent if the null hypothesis were true. More precisely, a study's defined significance level, denoted by \alpha, is the probability of the study rejecting the null hypothesis, given that the null hypothesis is true; and the p-value, ''p''-value of a result, ''p'', is the probability of obtaining a result at least as extreme, given that the null hypothesis is true. The result is said to be ''statistically significant'', by the standards of the study, when p \le \alpha. The significance level for a study is chosen before data collection, and is typically set to 5% or much lower—depending on the field of study. In any experiment or Observational study, observation that involves drawing a Sampling (statistics), sample from a Statistical population, population, there is always the possibility that an observed effect would have occurred due to sampling error al ...
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Pharmaceutical Industry
The pharmaceutical industry is a medical industry that discovers, develops, produces, and markets pharmaceutical goods such as medications and medical devices. Medications are then administered to (or self-administered by) patients for curing or preventing disease or for alleviating symptoms of illness or injury. Pharmaceutical companies may deal in generic drugs, branded drugs, or both, in different contexts. Generic materials are without the involvement of intellectual property, whereas branded materials are protected by chemical patents. The industry's various subdivisions include distinct areas, such as manufacturing biologics and total synthesis. The industry is subject to a variety of laws and regulations that govern the patenting, efficacy testing, safety evaluation, and marketing of these drugs. The global pharmaceutical market produced treatments worth a total of $1,228.45 billion in 2020. The sector showed a compound annual growth rate (CAGR) of 1.8% in 2021, ...
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