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Glossary of terms used in health research - I

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  • I2
    • A measure used to quantify heterogeneity. It describes the percentage of the variability in effect estimates that is due to heterogeneity rather than sampling error (chance). A value greater than 50% may be considered to represent substantial heterogeneity.
  • Ignorance of risks
    • An elementary form of innumeracy in which a person does not know, not even roughly, how great a relevant risk is. It differs from the illusion of certainty (for example, smoking cigarettes does not cause lung cancer) in that the person is aware that there are uncertainties, but does not know how great they are.
  • Illusion of certainty
    • The belief that an event is absolutely certain although it may not be. For instance, people tend to believe that the results of modern technologies, such as HIV testing, DNA fingerprinting, ordinary fingerprinting techniques, medical tests, or even the mechanical vote-counting machines used in elections are certain, that is, error free. The illusion can have benefits, such as reassurance, but also costs, such as suicide after a false positive HIV test. With respect to morals, religion, and political values, the illusion of certainty may be a requirement for being accepted by a social group, fostering social control.
  • Impact
    • The total, direct and indirect, effects of a program, service or institution on health status and overall health and socio-economic development.
  • Impact evaluation
    • Wikipedia
      Impact evaluation assesses the changes that can be attributed to a particular intervention, such as a project, program or policy, both the intended ones, as well as ideally the unintended ones. In contrast to outcome monitoring, which examines whether targets have been achieved, impact evaluation is structured to answer the question: how would participants’ well-being have changed if the intervention had not been undertaken? This involves counterfactual analysis, that is, a comparison between what actually happened and what would have happened in the absence of the intervention.
      Impact evaluation examines the initial effect of a program on proximal targets of change, such as policies, behaviors, or attitudes. Thus impact evaluation corresponds to assessment of the initial objectives of the program.
      Impact evaluation monitors the acceptance of recommendations and the implementation of recommendations once accepted.
  • Impact factor
    • MeSH - Wikipedia
      In a given year, the impact factor of a journal is the average number of citations to those papers that were published during the two preceding years. For example, the 2008 impact factor of a journal would be calculated as follows:
      A = the number of times articles published in 2006 and 2007 were cited by indexed journals during 2008
      B = the total number of "citable items" published in 2006 and 2007. ("Citable items" are usually articles, reviews, proceedings, or notes; not editorials or Letters-to-the-Editor.)
      2008 impact factor = A/B
      (Note that 2008 impact factors are actually published in 2009; they cannot be calculated until all of the 2008 publications have been received by the indexing agency.)
      A quantitative measure of the frequency on average with which articles in a journal have been cited in a given period of time.
      Also called journal impact factor.
  • Impartial witness
    • A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject's legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.
  • Implementation
    • Wikipedia
      The carrying out of a project or program.
  • Implementation research
    • The study of how a specific set of activities and designed strategies effect the integration of evidence-based information and interventions into health care and community health practices.
  • Imprecision
    • A quantification of the uncertainty in an estimate such as an effect size. Usually expressed as the 95% confidence interval around the estimate. Also refers more generally to other sources of uncertainty, such as measurement error.
  • In vitro
    • Wikipedia
      In the laboratory (outside the body). The opposite of in vivo (in the body).
      In vitro [MeSH - publication type]: studies using excised tissues.
  • In vivo
    • Wikipedia
      In the body. The opposite of in vitro (outside the body or in the laboratory).
  • Inception cohort
    • A designated group of persons assembled at a common time early in the development of a specific clinical disorder (for example, at the time of first exposure to the putative cause or the time of initial diagnosis) and who are followed thereafter.
  • Incidence
    • MeSH - Wikipedia
      The number of new cases of a disease diagnosed each year.
      The number of new occurrences of something in a population over a particular period of time, e.g. the number of cases of a disease in a country over one year.
      The number of instances of illness commencing or of persons falling ill, during a given period in a specified population. More generally, the number of new events, e.g., new cases of a disease in a defined population, within a specified period of time. The term incidence is sometimes used to denote incidence rate.
      The number of new cases of a given disease during a given period in a specified population. It also is used for the rate at which new events occur in a defined population. It is differentiated from prevalence, which refers to all cases, new or old, in the population at a given time.
  • Incidence rate
    • Wikipedia
      The number of persons contracting a disease per 1,000 population at risk, for a given period of time.
      A measure of the frequency with which an event, such as a new case of illness, occurs in a population over a period of time. The denominator is the population at risk; the numerator is the number of new cases occurring during a given time period.
  • Incidental findings
    • MeSH
      Unanticipated information discovered in the course of testing or medical care. Used in discussions of information that may have social or psychological consequences, such as when it is learned that a child's biological father is someone other than the putative father, or that a person tested for one disease or disorder has, or is at risk for, something else.
  • Incubation period
    • Wikipedia
      Incubation period is the time elapsed between exposure to a pathogenic organism, a chemical or radiation, and when symptoms and signs are first apparent.
      A period of subclinical or inapparent pathologic changes following exposure, ending with the onset of symptoms of infectious disease.
  • Inclusion criteria
    • Wikipedia
      The characteristics that define the population eligible for a study or that define the studies that will be eligible for inclusion in a systematic review.
  • Incorporation bias
    • Occurs when investigators study a diagnostic test that incorporates features of the target outcome. The result is a bias toward making the test appear more powerful in differentiating target positive from target negative than it actually is.
  • Incremental analysis
    • Refers to the process of estimating the additional cost per unit of outcome achieved when comparing one treatment modality to another (typically more expensive and more effective) form of treatment. Where the margin refers strictly to differences in scale within a treatment modality (such as increased throughput in an operating theatre), incremental change occurs when one compares different programs such as one view versus two view mammography. Incremental cost effectiveness refers to the difference in cost between the programs divided by the difference in outcome.
  • Independent
    • A description of two events, where knowing the outcome or value of one does not inform us about the outcome or value of the other. Formally, two events ‘A and B’ are independent if the probability that A and B occur together is equal to the probability of A occurring multiplied by the probability of B occurring.
  • Independent association
    • When a variable is associated with an outcome after adjusting for multiple other potential prognostic factors (often after regression analysis), the association is an independent association.
  • Independent ethics committee
    • An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical/scientific professionals and nonmedical/nonscientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favorable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
  • Independent variable
    • Wikipedia
      An exposure, risk factor, or other characteristic that is hypothesized to influence the dependent variable. In a clinical trial, the outcome (over which the investigator has no direct control) is the dependent variable, and the treatment arm is the independent variable. In an adjusted analysis, patient characteristics are included as additional independent variables. (Also called explanatory variable.)
      An exposure, risk factor, or other characteristic being observed or measured that is hypothesized to influence an event or manifestation (the dependent variable).
  • In-depth interview
    • A face-to-face conversation to explore issues; conducted without using a structured questionnaire.
  • Index
    • Wikipedia
      An index is a system used to make finding information easier.
      Indexes [MeSH - publication type]: works providing an analytical subject approach to materials in a field of knowledge.
  • Index date
    • The date of an important event that marks the beginning of monitoring patients for the occurrence of the outcome of interest.
  • Index test
    • The test whose diagnostic accuracy is being measured against the reference or gold standard.
  • Indication
    • Wikipedia
      In medicine, a sign, symptom, or medical condition that leads to the recommendation of a treatment, test, or procedure.
  • Indicators
    • Identified and measured variables which help to show changes directly and indirectly relevant to goals, objectives and targets.
      Indicators in the context of evaluation are simply one-dimensional measures that help to measure, to express, or at least to reflect and to simplify the more complex formulation of the objectives.
  • Indirect costs and benefits
    • The impact of alternative patient management strategies on the productivity of the patient and others involved in the patient’s care.
  • Individual data
    • Data that have not been put into a frequency distribution or rank ordered.
  • Individual patient data
    • In meta-analysis: the availability of raw data for each study participant in each included study, as opposed to aggregate data (summary data for the comparison groups in each study). Reviews using individual patient data require collaboration of the investigators who conducted the original studies, who must provide the necessary data.
  • Individual patient data meta-analysis
    • A meta-analysis in which individual patient data from each primary study are used to create pooled estimates. Such an approach can facilitate more accurate intention-to-treat analyses and informed subgroup analyses.
  • Induced abortion
    • MeSH - Wikipedia
      The termination of a clinical pregnancy, by deliberate interference that takes place before 20 completed weeks of gestational age (18 weeks post fertilization) or, if gestational age is unknown, of an embryo/fetus of less than 400 grams.
      Intentional removal of a fetus from the uterus by any of a number of techniques.
  • Inequity in access to health services
    • Differences in access to health services for equal health needs and/or absence of enhanced access for socially, demographically, or geographically defined population groups with greater health needs.
  • Inequity in health
    • The presence of systematic differences in one or more aspects of health across socially, demographically, or geographically defined population groups.
  • Inequity in receipt of health services
    • Inequalities in the receipt of health services for equal health needs and/or failure to receive increased or augmented services for socially, demographically, or geographically defined population groups with greater health needs.
  • Infant
    • MeSH - Wikipedia
      The term is typically applied to children between the ages of 1 month and 12 months; however, definitions vary between birth and 3 years of age.
      A child between 1 and 23 months of age.
  • Infant mortality
    • MeSH - Wikipedia
      Death in the first year of life.
      Postnatal deaths from birth to 365 days after birth in a given population. Postneonatal mortality represents deaths between 28 days and 365 days after birth (as defined by National Center for Health Statistics). Neonatal mortality represents deaths from birth to 27 days after birth.
  • Infant mortality rate
    • Wikipedia
      Probability of dying between birth and exactly one year of age expressed per 1000 live births.
      Infant mortality rate is the probability of a child born in a specific year or period dying before reaching the age of one, if subject to age-specific mortality rates of that period. Infant mortality rate is strictly speaking not a rate (i.e. the number of deaths divided by the number of population at risk during a certain period of time) but a probability of death derived from a life table and expressed as rate per 1,000 live births.
      The quotient between the number of deaths in children under 1 year of age in a given year and the number of live births in that year, for a given country, territory, or geographic area, expressed per 1,000 live births, as reported from the national health authority. The reported neonatal mortality rate is defined as the quotient between the number of children born alive that died before the age of 28 days in a given year and the number of live births in that year, for a given country, territory, or geographic area, expressed per 1,000 live births, as reported from the national health authority. The reported postneonatal mortality rate is defined as the quotient between the number of children that were alive after 27 days of age and died before the age of 1 year in a given year and the number of live births in that year, for a given country, territory, or geographic area, expressed per 1,000 live births, as reported from the national health authority. The estimated infant mortality rate is the quotient between the number of deaths in children under 1 year of age in a given year and the number of live births in that year, for a given country, territory, or geographic area, expressed per 1,000 live births, as estimated by the United Nations' Population Division.
      The number of deaths of infants under age 1 per 1,000 live births in a given year.
  • Infection control
    • MeSH - Wikipedia
      Infection control is the discipline concerned with preventing nosocomial or healthcare-associated infection.
      Programs of disease surveillance, generally within health care facilities, designed to investigate, prevent, and control the spread of infections and their causative microorganisms.
  • Inference
    • A generalization made about a population from the study of a subset or sample of that population.
  • Infertility
    • MeSH - Wikipedia
      Absence of conception after 12 months of regular, unprotected intercourse (commonly used medical definition of infertility).
      Inability to conceive within two years of exposure to pregnancy is the epidemiological definition recommended by the World Health Organization.
      Infertility (demographic studies): inability of a non-contracepting sexually active woman to have a livebirth. Demographers have shifted the endpoint from conceptions to live births because it is difficult to collect complete data about conceptions in population-based studies. In addition, demographic analyses of infertility are often based on secondary data from demographic surveys that contain complete birth histories, but no information about induced abortions, miscarriages and stillbirths. It is common in demographic studies to use a period of exposure of five years.
      Inability to reproduce after a specified period of unprotected intercourse. Reproductive sterility is permanent infertility.
  • Information dissemination
    • MeSH
      The circulation or wide dispersal of information.
  • Informational redundancy
    • In qualitative research, the point in the analysis at which new data fail to generate new themes and new information. This is considered an appropriate stopping point for data collection in most methods and an appropriate stopping point for analysis in some methods.
  • Informed consent
    • MeSH - Wikipedia
      An ethical requirement for participation in a research study, indicating that a competent person, in possession of all the relevant information, freely agrees to participate.
      A process in which a person is given important facts about a medical procedure or treatment, a clinical trial, or genetic testing before deciding whether or not to participate. It also includes informing the patient when there is new information that may affect his or her decision to continue. Informed consent includes information about the possible risks, benefits, and limits of the procedure, treatment, trial, or genetic testing.
      The process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study.
      A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form.
      A process in which the risks, benefits, and expectations of an intervention or research project are disclosed to a patient or participant in order for the participant to make an informed decision concerning acceptance or participation. Requires competence, voluntariness (autonomy and lack of coercion), disclosure, comprehension of risks, burdens, and benefits, and consent. Required by regulation and provided for in protocols by those requesting participation or agreement, consent should be viewed, not simply as a form and signature, but as a process engaging the candidate and allowing for “autonomous authorization”. Children may give assent—that is, agree to participate—though they may lack capacity or comprehension for true informed consent. Communities may be asked to give consent for community based research through elected leadership, existing community networks, or ad hoc advisory groups. The question of who speaks for the community is still a subject of discussion.
      Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment.
  • Informed consent document
    • MeSH
      A document that describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
      Documents describing a medical treatment or research project, including proposed procedures, risks, and alternatives, that are to be signed by an individual, or the individual's proxy, to indicate his/her understanding of the document and a willingness to undergo the treatment or to participate in the research.
      Also called consent forms.
  • Initial situation
    • Information relating to the target population such as drug knowledge/use, socio-economic and demographic data can all be included to assess initial situation. Data sources, social perceptions and public discussion related to the situation can also be added.
  • Inpatient
    • MeSH
      A patient who is formally admitted (or “hospitalized”) to an institution for treatment and/or care and stays for a minimum of one night in the hospital or other institution providing inpatient care.
      Persons admitted to health facilities which provide board and room, for the purpose of observation, care, diagnosis or treatment.
  • Inpatient treatment
    • In-patient treatment is treatment in which the patient spends the night in the treatment center.
  • Input
    • A quantified amount of a resource put in a process.
  • Inspection
    • Wikipedia
      The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organization’s (CROs) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).
  • Institution
    • Wikipedia
      Any public or private entity or agency or medical or dental facility where clinical trials are conducted.
      Any public or private entity or agency (including Federal, State, and other agencies).
  • Institutional ethics
    • MeSH
      The moral and ethical obligations or responsibilities of institutions.
  • Institutional review board
    • MeSH - Wikipedia
      A committee of physicians, statisticians, researchers, community advocates, and others that ensures that a clinical trial is ethical and that the rights of study participants are protected. All clinical trials in the U.S. must be approved by an IRB before they begin.
      Every institution that conducts or supports biomedical or behavioral research involving human participants must, by federal regulation, have an IRB that initially approves and periodically reviews the research in order to protect the rights of human participants.
      A group of scientists, doctors, clergy, and consumers that reviews and approves the action plan for every clinical trial. There is an Institutional Review Board at every health care facility that does clinical research. Institutional Review Boards are designed to protect the people who take part in a clinical trial. Institutional Review Boards check to see that the trial is well designed, legal, ethical, does not involve unnecessary risks, and includes safeguards for patients. Also called IRB.
      An independent body constituted of medical, scientific, and nonscientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trials, of protocols and amendments, and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
      Any board, committee, or other group formally designated by an institution to review biomedical research involving humans as subjects, to approve the initiation of and conduct periodic review of such research.
      Hospital or other institutional committees established to protect the welfare of research subjects. Federal regulations (the "Common Rule" (45 CFR 46)) mandate the use of these committees to monitor federally-funded biomedical and behavioral research involving human subjects.
      Also called research ethics committee.
  • Instruments
    • Instruments refer to all the tools that are used to collect information on the target group, the evaluation, etc. The most widely used instruments in evaluation are self-report questionnaires. Other instruments include tests, ratings, interviews and observation instruments.
  • Intent to treat
    • Wikipedia
      The principle that asserts that the effect of a treatment policy can be best assessed by evaluating on the basis of the intention to treat a subject (i.e. the planned treatment regimen) rather than the actual treatment given. It has the consequence that subjects allocated to a treatment group should be followed up, assessed and analyzed as members of that group irrespective of their compliance to the planned course of treatment.
  • Intention to treat analysis
    • MeSH - Wikipedia
      Analysis of clinical trial results that includes all data from participants in the groups to which they were randomized even if they never received the treatment.
      A strategy for analyzing data from a randomized controlled trial. All participants are included in the arm to which they were allocated, whether or not they received (or completed) the intervention given to that arm. Intention-to-treat analysis prevents bias caused by the loss of participants, which may disrupt the baseline equivalence established by randomization and which may reflect non-adherence to the protocol. The term is often misused in trial publications when some participants were excluded.
      Strategy for the analysis of randomized controlled trials that compares patients in the groups to which they were originally randomly assigned.
  • Interaction
    • Wikipedia
      The situation in which a treatment contrast (e.g. difference between investigational product and control) is dependent on another factor (e.g. centre). A quantitative interaction refers to the case where the magnitude of the contrast differs at the different levels of the factor, whereas for a qualitative interaction the direction of the contrast differs for at least one level of the factor.
      The situation in which the effect of one independent variable on the outcome is affected by the value of a second independent variable. In a trial, a test of interaction examines whether the treatment effect varies across sub-groups of participants.
  • Interactive programs
    • Programs that use participatory teaching and learning methods (i.e. group discussions, group exercises).
  • Interim analysis
    • Wikipedia
      Any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to the formal completion of a trial.
      Analysis comparing intervention groups at any time before the formal completion of a trial, usually before recruitment is complete. Often used with stopping rules so that a trial can be stopped if participants are being put at risk unnecessarily. Timing and frequency of interim analyses should be specified in the protocol.
  • Interim clinical trial/study report
    • A report of intermediate results and their evaluation based on analyses performed during the course of a trial.
  • Internal evaluator
    • An individual (or group of individuals) from within the organization being evaluated who is (are) responsible for collecting, analyzing and interpreting data.
  • Internal validity
    • Wikipedia
      The extent to which the design and conduct of a study are likely to have prevented bias. Variation in quality can explain variation in the results of studies included in a systematic review. More rigorously designed (better quality) trials are more likely to yield results that are closer to the truth. (Also called methodological quality but better thought of as relating to bias prevention.)
      The index and comparison groups are selected and compared in such a manner that the observed differences between them on the dependent variables under study may, apart from sampling error, be attributed only to the hypothesized effect under investigation.
  • Interobserver reliability
    • The extent to which observers rating or measuring a particular phenomenon agree with each other.
  • Interpolation
    • Wikipedia
      Mathematical process by which mortality-rate findings are applied to the entire population that the study is representative of, so as to obtain total numbers of deaths or percentages of the population that died over the recall period investigated.
  • Interquartile range
    • Wikipedia
      The distance between the scores representing the 25th and 75th percentile ranks in a distribution.
      The central portion of a distribution, calculated as the difference between the third quartile and the first quartile; this range includes about one-half of the observations in the set, leaving one-quarter of the observations on each side.
  • Interrater reliability
    • Wikipedia
      The property of yielding equivalent results when used by different raters on different occasions.
      The degree of stability exhibited when a measurement is repeated under identical conditions by different raters. Reliability refers to the degree to which the results obtained by a measurement procedure can be replicated. Lack of inter-rater reliability may arise from divergences between observers or instability of the attribute being measured.
  • Interrupted time series
    • A research design that collects observations at multiple time points before and after an intervention (interruption). The design attempts to detect whether the intervention has had an effect significantly greater than the underlying trend.
  • Intersectoral action
    • Action in which the health sector and other relevant sectors of the economy collaborate, or interact to pursue health goals.
  • Intervention
    • Wikipedia
      In medicine, a treatment or action taken to prevent or treat disease, or improve health in other ways.
      The process of intervening on people, groups, entities or objects in an experimental study. In controlled trials, the word is sometimes used to describe the regimens in all comparison groups, including placebo and no-treatment arms.
      An activity or set of activities aimed at modifying a process, course of action or sequence of events, in order to change one or several of their characteristics such as performance or expected outcome.
  • Intervention group
    • The group receiving the study agent that is being tested in a clinical trial or clinical study.
      A group of participants in a study receiving a particular health care intervention. Parallel group trials include at least two intervention groups.
  • Intervention name
    • The generic name of the precise intervention being studied.
  • Intervention-specific instruments
    • Instruments of examination, observation‚ or evaluation that were specifically constructed for an intervention.
  • Intervention studies
    • MeSH
      Epidemiologic investigations designed to test a hypothesized cause-effect relation by modifying the supposed causal factor(s) in the study population.
  • Interview
    • MeSH
      In qualitative research, this is one of 3 basic data collection methods. It involves an interviewer asking questions to engage participants in dialogue to allow interpretation of experiences and events in the participants’ own terms. The 2 most common interviews are semistructured, detailed interviews of individuals or discussion-based interviews of several people, called focus groups. In quantitative research, a method of collecting data in which an interviewer obtains information from a participant through conversation.
      In evaluation research, the interview is an instrument used to assess data on the implementation process and outcome. Interviews can differ in their degree of standardization (structured, semi-structured or unstructured interviews), the type of contact (face-to-face, telephone or written), or the number of people interviewed at the same time (individual or group interviews).
      Conversations with an individual or individuals held in order to obtain information about their background and other personal biographical data, their attitudes and opinions, etc. It includes school admission or job interviews.
      Interview [MeSH - publication type]: work consisting of a conversation with an individual regarding his or her background and other personal and professional details, opinions on specific subjects posed by the interviewer, etc.
  • Interviewer bias
    • Wikipedia
      Systematic error due to interviewer's subconscious or conscious gathering of selective data.
  • Intraclass correlation coefficient
    • Wikipedia
      This is a measure of reproducibility that compares variance between patients to the total variance, including both between- and within-patient variance.
  • Intramural
    • Within (the walls or boundaries of) a community or institution (e.g. a university). Used to distinguish from ‘external’ (extramural) sources of support (such as funding).
  • Intrarater reliability
    • Wikipedia
      The property of yielding equivalent results when used by the same rater on different occasions.
      The degree of stability exhibited when a measurement is repeated under identical conditions by the same rater. Reliability refers to the degree to which the results obtained by a measurement procedure can be replicated. Lack of intra-rater reliability may arise from divergences between instruments of measurement, or instability of the attribute being measured.
  • Introductory journal article
    • Prefactory summary to a special issue or section of a journal devoted to a specific topic. This introductory text can be of varying length and substance.
  • Inverse of variance
    • The most common kind of weight used to combine individual studies in a summary estimate. It can be applied to many effect sizes (relative risk, odds ratio, risk difference, proportions—like sensitivity or specificity—, etc.) and in observational studies when adjusted effect sizes (odds ratio, relative risk) are provided.
  • Investigational
    • In clinical trials, refers to a drug (including a new drug, dose, combination, or route of administration) or procedure that has undergone basic laboratory testing and received approval from the U.S. Food and Drug Administration (FDA) to be tested in human subjects. A drug or procedure may be approved by the FDA for use in one disease or condition, but be considered investigational in other diseases or conditions. Also called experimental.
  • Investigational drug
    • MeSH - Wikipedia
      A substance that has been tested in a laboratory and has gotten approval from the U.S. Food and Drug Administration (FDA) to be tested in people. A drug may be approved by the FDA for use in one disease or condition but be considered investigational in other diseases or conditions. Also called experimental drug.
      A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
      Drugs which have received FDA approval for human testing but have yet to be approved for commercial marketing. This includes drugs used for treatment while they still are undergoing clinical trials (Treatment IND). The main heading includes drugs under investigation in foreign countries.
  • Investigational new drug
    • Wikipedia
      A new drug, antibiotic drug, or biological drug that is used in a clinical investigation. It also includes a biological product used in vitro for diagnostic purposes.
  • Investigational new drug application
    • MeSH
      An application that must be submitted to a regulatory agency (the FDA in the United States) before a drug can be studied in humans. This application includes results of previous experiments; how, where, and by whom the new studies will be conducted; the chemical structure of the compound; how it is thought to work in the body; any toxic effects found in animal studies; and how the compound is manufactured.
  • Investigator
    • Wikipedia
      A researcher in a clinical trial or clinical study.
      A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.
      An individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.
  • Investigator triangulation
    • Wikipedia
      Investigator triangulation requires more than one investigator to collect and analyze the raw data, such that the findings emerge through consensus among a team of investigators.
  • Investigator's brochure
    • Wikipedia
      A compilation of the clinical and nonclinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects.