Biostatistics Ch.1

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Biostatistics

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biostatistics is the science of collecting, analyzing, and interpreting biomedical and healthcare data

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blinded study

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a blinded study is a research study where the subjects in the study are not told which treatment they are receiving. A research study is a double-blind study when neither the subject nor the staff administering the treatment knows which treatment a subject receives.

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case-control study

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a retrospective study in which subjects having a certain disease or condition are compared with subjects who do not have the disease

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census

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a census is a simple consisting of the entire set of population units.

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clinical trial

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a research study performed on humans and designed to evaluate a new treatment or drug to investigate a specific health condition that follows a predefined protocol.

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cohort

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a cohort is a group of subjects having similar characteristics.

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cross-sectional study

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a study to investigate the relationship between a response variable and the explanatory variables in a target population at a particular point in time.

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experiment

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a study where the researcher controls the assignment of the units to the treatments

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explanatory variable

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a variable that is used to explain or is believed to cause changes in the response variable. Also called the independent variables or predictor variables

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longitudinal study

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a study where the same subjects are observed over a specific period of time. Could be either a prospective or retrospective study.

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observational study

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any study where the units of the study come to the researchers already assigned to the subpopulations or treatment groups.

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parameter

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numerical measure of a characteristic of the population

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phase I clinical trial

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designed for investigating the safety, efficacy, and side effects of a new drug or treatment. AKA, dose finding trials

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phase II clinical trial

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is used to further investigate the effectiveness, feasibility and safety of a drug or treatment. AKA, safety and efficacy trials and usually have a larger sample size than phase I trial

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phase III clinical trial

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is designed to gather additional information that will be used in evaluating the overall benefit-risk relationship of the drug. Are generally large trials and aka, comparative treatment efficacy trials.

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phase IV clinical trial

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a postmarketing study sedigned to obtain additional information on the risks associated with the drug/treatment, its benefits, and its optimal use. The primary use of this clinical trial is to evaluate the long-term safety and effectiveness of the drug/treatment. AKA expanded safety trials and usually involve a large number of subjects.

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population units

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objects on which measurements will be taken. When the units of the population are human beings, they are referred to as subjects or individuals.

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prospective study

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a study that monitors the units over a period of time and analyzes what happens to the units in the study.

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randomized controlled study

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research study where the subjects are randomly assigned to the treatments with one of the treatments being a control treatment; a control treatment may be a standard treatment, a placebo, or no treatment at all.

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response variable

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observed variable or outcome variable in an experiment or study that is believed to depend on other variables in the study. The response variable is also called a dependent variable.

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retrospective study

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a study that looks backwards in time and analyses what has happened to the units in the study.

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sample

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a subset of population units. a random sample is a sample that is chosen according to a sampling plan where the probability of each possible sample that can be drawn from the target population is known, where the probability of sampling each unit in the population is known.

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statistic

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any value that is computed from only the sample observations and known values.

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statistical inferences

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are estimates, conclusions, or generalizations made about the target population from the information contained in an observed sample.

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statistical model

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a mathematical formula that relates the response variable to the explanatory variables.

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target population

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the population of units that is being studied.

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treatment

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any experimental condition that is applied to the units. a placebo treatment is an inert or inactive treatment that is applied to the units.

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variable

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characteristic that will be recorded or measured on a unit in the target population.