Statistical inference is the process of using data analysis to infer properties of an underlying distribution of probability. Inferential statistical analysis infers properties of a population, for example by testing hypotheses and deriving estimates. It is assumed that the observed data set is sampled from a larger population.
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 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.
A laboratory information management system (LIMS), sometimes referred to as a laboratory information system (LIS) or laboratory management system (LMS), is a software-based solution with features that support a modern laboratory's operations. Key features include—but are not limited to—workflow and data tracking support, flexible architecture, and data exchange interfaces, which fully "support its use in regulated environments". The features and uses of a LIMS have evolved over the years from simple sample tracking to an enterprise resource planning tool that manages multiple aspects of laboratory informatics.
SAS is a statistical software suite developed by SAS Institute for data management, advanced analytics, multivariate analysis, business intelligence, criminal investigation, and predictive analytics. SAS' analytical software is built upon artificial intelligence and utilizes machine learning, deep learning and generative AI to manage and model data. The software is widely used in industries such as finance, insurance, health care and education.
SUDAAN is a proprietary statistical software package for the analysis of correlated data, including correlated data encountered in complex sample surveys. SUDAAN originated in 1972 at RTI International. Individual commercial licenses are sold for $1,460 a year, or $3,450 permanently.
JMP is a suite of computer programs for statistical analysis developed by JMP, a subsidiary of SAS Institute. It was launched in 1989 to take advantage of the graphical user interface introduced by the Macintosh operating systems. It has since been significantly rewritten and made available also for the Windows operating system. JMP is used in applications such as Machine Learning, Six Sigma, quality control, design of experiments, as well as for research in science, engineering, biotechnologies, and social sciences.
An electronic data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices. EDC solutions are widely adopted by pharmaceutical companies and contract research organizations (CRO).
A data monitoring committee (DMC) – sometimes called a data and safety monitoring board (DSMB) – is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.
Rintatolimod, sold under the tradename Ampligen, is a medication intended for treatment of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). There is some evidence it may improve some ME/CFS symptoms.
Verification and validation are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. "Independent verification and validation" can be abbreviated as "IV&V".
A glossary of terms used in clinical research.
The following outline is provided as an overview of and topical guide to clinical research:
StatXact is a statistical software package for analyzing data using exact statistics. It calculates exact p-values and confidence intervals for contingency tables and non-parametric procedures. It is marketed by Cytel Inc.
Guidances for statistics in regulatory affairs refers to specific documents or guidelines that provide instructions, recommendations, and standards pertaining to the application of statistical methodologies and practices within the regulatory framework of industries such as pharmaceuticals and medical devices. These guidances serve as a reference for statisticians, researchers, and professionals involved in designing, conducting, analyzing, and reporting studies and trials in compliance with regulatory requirements. These documents embody the prevailing perspectives of regulatory agencies on specific subjects. It is worth noting that in the United States, the term "Guidances" is used, while in Europe, the term "Guidelines" is employed.
nQuery is a clinical trial design platform used for the design and monitoring of adaptive, group sequential, and fixed sample size trials. It is most commonly used by biostatisticians to calculate sample size and statistical power for adaptive clinical trial design. nQuery is proprietary software developed and distributed by Statsols. The software includes calculations for over 1,000 sample sizes and power scenarios.
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 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 provides not only a summary of different adaptive designs, but also comprehensive information on adaptive design planning, conduct, analysis and reporting.
Guosheng Yin is a statistician, data scientist, educator and researcher in Biostatistics, Statistics, machine learning, and AI. Presently, Guosheng Yin is Chair in Statistics in Department of Mathematics at Imperial College London. Previously, he served as the Head of Department and the Patrick S C Poon Endowed Chair in Statistics and Actuarial Science, at the University of Hong Kong. Before he joined the University of Hong Kong, Yin worked at the University of Texas M.D. Anderson Cancer Center till 2009 as a tenured Associate Professor of Biostatistics.
