II. Types: Randomized Study

  1. Randomized Clinical Trial
    1. In randomized trials, participants are assigned by chance to different groups
    2. Researchers and participants are typically "blinded" to the assigned group
  2. Randomized Controlled Trial (RCT)
    1. In randomized controlled trials, a control group is compared to one or more treatment groups
    2. As with other randomized trials, researchers and participants are typically "blinded" to group assignment
    3. Randomized Controlled Trials, when performed well, are the most reliable level of Research Study

III. Types: Observational Studies

  1. Observational Study
    1. Individuals are observed or specific outcomes are measured
    2. No intervention is performed to attempt to alter the outcome of those studied
  2. Cohort study
    1. Cross-section or population is selected (e.g. nurses)
    2. Group selection is based on specific characteristics that researchers intend to study (e.g. nurses who smoke versus non-smokers)
    3. Study participants are followed, evaluating specific outcome measures at specific time points (e.g. cancer at 5, 10, 15 and 20 years)
    4. Cohort studies may be retrospective (e.g. historical database reviews) or prospective
    5. Risk of confounding factors that distort results
  3. Case-control study
    1. Two groups of participants are studied: One group with a disease, and the other without
      1. The 2 groups are otherwise similar (age, gender, socioeconomic factors)
    2. Each group is interviewed with medical medical review and other analysis
      1. Researchers identify factors that distinguish the 2 groups and may identify causative factors for those with the disease
  4. Cross Sectional Study
    1. A specific, random cohort of participants (e.g. 20 year old men) are studied (interviewed, surveyed) at single point in time
  5. Qualitative Study
    1. Research focuses on nonnumeric data to investigate individual or group characteristics
    2. Describes experience and behaviors, Perceptions and beliefs with language

IV. Types: Additional Statistical Analysis Tools

  1. Intention to Treat Analysis (ITT)
    1. Statistical analysis of study participants based on the original, randomized treatment group assignment
    2. Includes patients regardless of the treatment they ultimately received (or did not receive)
    3. ITT reduces the study bias that comes from excluding patients who are not fully compliant with study protocol
  2. Propensity Score matching
    1. Used by observational studies to simulate a Randomized Control Trial
    2. Randomization is simulated by applying statistical techniques to divide a large study cohort into groups
    3. Goal is for groups to be similar in all identified characteristics OTHER than those factors being studied
    4. Propensity Score is the probability of group assignment based on baseline characteristics
  3. Run-in Period
    1. Study technique in which all participants are given a Placebo after study inclusion but BEFORE randomization
      1. Identifies participants most suitable as study participants
      2. Intended to exclude certain participants (e.g. Placebo responders, noncompliance)
    2. Run-in Periods are intended to increase a study's power, more likely to detect a statistical difference
    3. Used more commonly in industry sponsored studies
    4. Risk of decreased external validity, and risks participant unblinding
      1. Laursen (2019) Clin Epidemiol 11:169-84 +PMID: 30809104 [PubMed]

V. Resources

  1. What types of Studies are there? (InformedHealth.org)
    1. https://www.ncbi.nlm.nih.gov/books/NBK390304/

Images: Related links to external sites (from Bing)

Related Studies

Ontology: Case-Control Studies (C0007328)

Definition (NCI_NCI-GLOSS) A study that compares two groups of people: those with the disease or condition under study (cases) and a very similar group of people who do not have the disease or condition (controls). Researchers study the medical and lifestyle histories of the people in each group to learn what factors may be associated with the disease or condition. For example, one group may have been exposed to a particular substance that the other was not. Also called retrospective study.
Definition (MSH) Studies which start with the identification of persons with a disease of interest and a control (comparison, referent) group without the disease. The relationship of an attribute to the disease is examined by comparing diseased and non-diseased persons with regard to the frequency or levels of the attribute in each group.
Concepts Research Activity (T062)
MSH D016022
English Case Base Studies, Case Comparison Studies, Case Compeer Studies, Case Control Studies, Case Control Study, Case Referent Studies, Case Referrent Studies, Case-Base Studies, Case-Base Study, Case-Comparison Studies, Case-Comparison Study, Case-Compeer Studies, Case-Compeer Study, Case-Control Studies, Case-Referent Studies, Case-Referent Study, Case-Referrent Studies, Case-Referrent Study, Studies, Case Control, Studies, Case-Base, Studies, Case-Comparison, Studies, Case-Compeer, Studies, Case-Control, Studies, Case-Referent, Studies, Case-Referrent, Study, Case Control, Study, Case-Base, Study, Case-Comparison, Study, Case-Compeer, Study, Case-Control, Study, Case-Referent, Study, Case-Referrent, based case study, case-control studies, case control studies, case control study, case-control study, Case-Control Study
Swedish Fall-kontrollstudier
Czech studie případů a kontrol, případové studie
Finnish Tapaus-verrokkitutkimukset
French Études de cas-témoins, Études cas-témoins
Italian Studi caso-comparato, Studi caso-base, Studi caso-referente, Studi caso-controllo
Russian GNEZDOVYE ISSLEDOVANIIA SLUCHAI-KONTROL', SRAVNITEL'NYE ISSLEDOVANIIA SLUCHAI-KONTROL', SLUCHAI-KONTROL' ISSLEDOVANIIA, ГНЕЗДОВЫЕ ИССЛЕДОВАНИЯ СЛУЧАЙ-КОНТРОЛЬ, СЛУЧАЙ-КОНТРОЛЬ ИССЛЕДОВАНИЯ, СРАВНИТЕЛЬНЫЕ ИССЛЕДОВАНИЯ СЛУЧАЙ-КОНТРОЛЬ
Japanese ケースベーススタディ, 症例参照法, 患者対照研究, 症例参照研究, ケースコントロール研究, 照合症例対照法, ケースコントロールスタディ, 症例比較法, 症例対照法, 患者-対照研究, 症例対照研究
Croatian KLINIČKI SLUČAJEVI, KONTROLNA ISPITIVANJA
Polish Badania typu case-control, Badania przypadek-kontrola
Norwegian Kasuskontrollstudier, Kasuskontroll-studier
Spanish Estudios de Casos y Controles Combinados, Estudios de Casos y Controles, Estudios de Referencia de Casos, Grupos de Estudio, Estudios de Comparación de Casos
Portuguese Estudos de Caso-Controle Combinados, Estudos de Casos e Controles, Estudos de Comparação de Casos, Estudos de Referência de Casos, Grupos de Estudo
German Einzelfallbezugsstudien, Einzelfallstudien, Fall-Kontroll-Studien, Fallvergleichsstudien
Dutch Case-control-studie, Studie, case-control-

Ontology: Clinical Trials (C0008976)

Definition (HL7V3.0) <p><b>Description:</b>Healthcare provided or withheld in the course of conducting research</p>
Definition (MEDLINEPLUS)

Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available.

Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can take part. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women.

In the United States, an independent committee of physicians, statisticians, and members of the community must approve and monitor the protocol. They make sure that the risks are small and are worth the potential benefits.

NIH: National Institutes of Health

Definition (NCI) A research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioral treatments, process-of-care changes, and preventive care.(World Health Organization, International Clinical Trials Registry Platform)
Definition (NCI_NCI-GLOSS) A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease.
Definition (MSH) Pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.
Definition (PSY) Systematic, planned studies to evaluate the safety and efficacy of drugs, devices, or diagnostic or therapeutic practices. Used only when the methodology is the focus of discussion.
Definition (CSP) controlled study designed to assess the safety and efficacy of new drugs, devices, treatments, or preventive measures in humans by comparing two or more interventions or regimens; prefer specific phase NTs.
Concepts Research Activity (T062)
MSH D002986
SnomedCT 110465008
HL7 CLINTRL
English Clinical Trials, Clinical Trial as Topic, Clinical Trials as Topic, Clinical Trial, Trial, Clinical Trials, Unspecified, clinical trial, clinical trials, Clinical trials, Clinical trial, Clinical trial (procedure), Clinical trials (procedure)
Portuguese Ensaios Clínicos como Assunto, Estudos Clínicos como Assunto
Spanish Ensayos Clínicos como Asunto, pruebas clínicas, análisis clínicos, estudios clínicos, Ensayos Clínicos como Tema, ensayos clínicos (procedimiento), ensayos clínicos
Finnish Kliiniset kokeet aiheena
French Essais cliniques comme sujet
Italian Sperimentazione clinica (come argomento), Sperimentazioni cliniche (come argomento)
Russian КЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯ КАК ТЕМА, KLINICHESKIE ISSLEDOVANIIA KAK TEMA
Swedish Kliniska prövningar, principer
Czech klinické zkoušky jako téma, klinické hodnocení léčiv, klinické hodnocení zdravotnického prostředku, klinické hodnocení léčivých přípravků, klinické testy léčiv
Croatian KLINIČKA ISPITIVANJA (TEMA RADA)
Polish Badania kliniczne, Kliniczna ocena leku
Norwegian Kliniske utprøvinger, emne
German Klinische Studien

Ontology: Cohort Studies (C0009247)

Definition (NCI_NCI-GLOSS) A research study that compares a particular outcome (such as lung cancer) in groups of individuals who are alike in many ways but differ by a certain characteristic (for example, female nurses who smoke compared with those who do not smoke).
Definition (MSH) Studies in which subsets of a defined population are identified. These groups may or may not be exposed to factors hypothesized to influence the probability of the occurrence of a particular disease or other outcome. Cohorts are defined populations which, as a whole, are followed in an attempt to determine distinguishing subgroup characteristics.
Concepts Quantitative Concept (T081)
MSH D015331
English Cohort Studies, Concurrent Studies, Concurrent Study, Studies, Cohort, Studies, Concurrent, Study, Cohort, Study, Concurrent, cohort study, cohort studies, Cohort Study
Swedish Kohortstudier
Finnish Kohorttitutkimukset
French Études de cohortes
Russian KOGORTNYI ANALIZ, KOGORTNYE ISSLEDOVANIIA ISTORICHESKIE, NASELENIIA GRUPP IZUCHENIE, KOGORTNYE EPIDEMIOLOGICHESKIE ISSLEDOVANIIA, КОГОРТНЫЕ ИССЛЕДОВАНИЯ ИСТОРИЧЕСКИЕ, КОГОРТНЫЕ ЭПИДЕМИОЛОГИЧЕСКИЕ ИССЛЕДОВАНИЯ, КОГОРТНЫЙ АНАЛИЗ, НАСЕЛЕНИЯ ГРУПП ИЗУЧЕНИЕ
Japanese コホート研究, 同時調査, 歴史的コホート研究, コホート分析, コホート調査, 発病率調査, 閉鎖コホート研究
Italian Studi concorrenti, Studi di coorte
Croatian KOHORTNE STUDIJE
Polish Badania kohortowe, Analiza kohortowa
Czech kohortové studie, skupinové studie
Norwegian Kohortundersøkinger, Kohortstudier
German Kohortenstudien
Dutch Cohortstudie, Cohortstudies, Parallelstudies, Studie, cohort-
Portuguese Estudos de Coortes
Spanish Estudios de Cohortes, Estudios de Concurrencia

Ontology: Cross-Sectional Studies (C0010362)

Definition (NCI) A study in which participants are examined at only a single time for characteristics of a disease.
Definition (MSH) Studies in which the presence or absence of disease or other health-related variables are determined in each member of the study population or in a representative sample at one particular time. This contrasts with LONGITUDINAL STUDIES which are followed over a period of time.
Concepts Research Activity (T062)
MSH D003430
English Analyses, Cross Sectional, Analyses, Cross-Sectional, Analysis, Cross Sectional, Analysis, Cross-Sectional, Cross Sectional Analyses, Cross Sectional Analysis, Cross Sectional Studies, Cross Sectional Survey, Cross-Sectional Analyses, Cross-Sectional Analysis, Cross-Sectional Studies, Cross-Sectional Survey, Cross-Sectional Surveys, Disease Frequency Survey, Disease Frequency Surveys, Studies, Cross-Sectional, Study, Cross-Sectional, Survey, Cross-Sectional, Survey, Disease Frequency, Surveys, Cross-Sectional, Surveys, Disease Frequency, CROSS SECTIONAL STUDIES, DIS FREQUENCY SURVEYS, ANAL CROSS SECTIONAL, CROSS SECTIONAL ANAL, SURVEYS DIS FREQUENCY, Cross-Sectional Study, cross-sectional study, cross-sectional studies, cross sectional study
French Études transversales, Enquêtes tranversales, Analyses transversales, Enquêtes de fréquence de maladie
Swedish Tvärsnittsstudier
Czech průřezové studie, průřezové analýzy
Finnish Poikkileikkaustutkimukset
Russian POPERECHNYE ISSLEDOVANIIA, ZABOLEVAEMOSTI RASPROSTRANENNOSTI IZUCHENIE, ЗАБОЛЕВАЕМОСТИ РАСПРОСТРАНЕННОСТИ ИЗУЧЕНИЕ, ПОПЕРЕЧНЫЕ ИССЛЕДОВАНИЯ
Japanese 発病頻度調査, 断面調査研究, 断面調査, 有病調査, 横断的研究, 断面調査法, 横断研究, 断面研究
Italian Indagine trasversale, Analisi trasversali, Analisi di frequenza delle malattie, Studi trasversali
Croatian UČESTALOST BOLESTI, ISTRAŽIVANJA
Polish Badanie pojawiania się chorób, Badania przekrojowe, Badania poprzeczne
Norwegian Tverrsnittsstudier
Spanish Estudios Seccionales, Estudios de Corte Transversal, Encuestas de Frencuencia de Enfermedades, Estudios Transversales
Portuguese Estudos Seccionais, Estudos de Corte Transversal, Estudos Transversais, Levantamentos de Frequência de Doenças
German Querschnittsstudien, Querschnittsuntersuchungen, Krankheitshäufigkeitsuntersuchungen
Dutch Cross-sectioneel onderzoek, Onderzoek, cross-sectioneel, Ziektefrequentie-onderzoek

Ontology: Clinical Trials, Randomized (C0206034)

Definition (NCI_NCI-GLOSS) A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.
Concepts Research Activity (T062) , Intellectual Product (T170)
MSH D016032
English Trials, Randomized Clinical, TRIALS RANDOMIZED CLIN, CLIN TRIALS RANDOMIZED, clinical randomize trials, clinical randomized trials, randomized clinical trials, randomized clinical trial, Randomized Clinical Trials, Randomized Clinical Trial, Clinical Trials, Randomized
Portuguese Ensaios Clínicos Aleatórios
Spanish Ensayos Clínicos Aleatorios
German Klinische Versuche, randomisierte
French Essais cliniques randomisés
Norwegian Kliniske utprøvinger, randomiserte
Czech randomizované klinické zkoušky
Dutch Trials, gerandomiseerde klinische

Ontology: Controlled Clinical Trials, Randomized (C0206035)

Definition (NCI) A study in which the participants are assigned by chance to separate groups to evaluate treatments. The study also includes a control group, which is undergoing the same rigors of the study with placebo treatment or standard treatment. The trial can also be controlled by the addition of a test group to ensure there are no factors present to skew the results and by the inclusion of peer-review analysis by appropriate government officials. 2005
Concepts Research Activity (T062)
MSH D016032
English Randomized Controlled Clinical Trial, CONTROLLED CLIN TRIALS RANDOMIZED, Controlled Clinical Trials, Randomized
Portuguese Ensaios Controlados Aleatórios
Spanish Ensayos Controlados Aleatorios
French Essais cliniques contrôlés randomisés
German Kontrollierte klinische Versuche, randomisierte
Norwegian Kontrollerte kliniske utprøvinger, randomiserte
Czech randomizované kontrolované klinické zkoušky
Dutch Trials, gerandomiseerde en gecontroleerde klinische

Ontology: Qualitative Research (C0949415)

Definition (MSH) Any type of research that employs nonnumeric information to explore individual or group characteristics, producing findings not arrived at by statistical procedures or other quantitative means. (Qualitative Inquiry: A Dictionary of Terms Thousand Oaks, CA: Sage Publications, 1997)
Definition (PSY) A type of research methodology that produces descriptive data, with little emphasis given to numerical quantification. Used only when the methodology or research itself is the focus of discussion.
Concepts Research Activity (T062)
MSH D036301
Swedish Kvalitativ forskning
Czech kvalitativní výzkum
Finnish Kvalitatiivinen tutkimus
Russian NAUCHNOI INTERPRETATSII KACHESTVA ISSLEDOVANIE, NAUCHNAIA INTERPRETATSIIA, ISSLEDOVANIE KACHESTVA, НАУЧНАЯ ИНТЕРПРЕТАЦИЯ, ИССЛЕДОВАНИЕ КАЧЕСТВА, НАУЧНОЙ ИНТЕРПРЕТАЦИИ КАЧЕСТВА ИССЛЕДОВАНИЕ
Croatian KVALITATIVNO ISTRAŽIVANJE, KVALITATIVNE METODE ISTRAŽIVANJA
English qualitative studies, qualitative research, research qualitative, qualitative study, Qualitative Research, Research, Qualitative, Qualitative research
Polish Badania jakościowe
Norwegian Forskning, kvalitativ, Kvalitativ forskning
French Recherche qualitative
German Qualitative Forschung
Italian Ricerca qualitativa
Dutch Kwalitatief onderzoek
Portuguese Pesquisa Qualitativa
Spanish Investigación Cualitativa

Ontology: Randomized Controlled Trial (publication) (C1096777)

Definition (MSH) Work consisting of a clinical trial that involves at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table.
Concepts Research Activity (T062) , Intellectual Product (T170)
MSH D016449
English Randomized Controlled Trial, Randomized Controlled Trial (publication)
Portuguese Ensaio Clínico Controlado Aleatório, Ensaio Clínico Controlado Randomizado, Ensaio Controlado Aleatório
Spanish Ensayo Clínico Controlado Aleatorio, Ensayo Controlado Aleatorio, Ensayo Clínico Controlado Randomizado
Finnish Satunnaistetut kontrolloidut tutkimukset
Italian Sperimentazione clinica controllata randomizzata
Russian РАНДОМИЗИРОВАННОЕ КОНТРОЛИРУЕМОЕ КЛИНИЧЕСКОЕ ИССЛЕДОВАНИЕ, RANDOMIZIROVANNOE KONTROLIRUEMOE KLINICHESKOE ISSLEDOVANIE
Japanese 臨床試験-無作為化比較, 無作為化比較臨床試験, 無作為臨床試験, 比較臨床試験-ランダム化, 臨床試験-無作為, 無作為化比較試験, 臨床試験-ランダム化比較, 比較臨床試験-無作為化, ランダム化比較試験
Swedish Randomiserad klinisk prövning
Polish Próba losowa kontrolowana-typ publikacji
Croatian RANDOMIZIRANA KONTROLIRANA STUDIJA, RANDOMIZIRANO KONTROLIRANO ISPITIVANJE
Czech randomizované kontrolované zkoušky
French Essai contrôlé randomisé
Norwegian Not Translated[Randomized Controlled Trial]
German Randomisierte klinische Studie [Dokumenttyp]

Ontology: Observational Study (C1518527)

Definition (MSH) A clinical study in which participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions (as in an interventional study).
Definition (NCI_NCI-GLOSS) A type of study in which individuals are observed or certain outcomes are measured. No attempt is made to affect the outcome (for example, no treatment is given).
Definition (NCI) Studies among cancer patients and healthy populations that involve no intervention or alteration in the status of the participants.
Definition (NCI_CDISC) Studies in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.
Concepts Research Activity (T062)
MSH D064888
English Observational Trial, Observational Study, observational study, OBSERVATIONAL
Czech pozorovací studie
French Étude d'observation, Étude observationnelle
German Beobachtungsstudie
Italian Studio osservazionale
Norwegian Observasjonsstudie
Russian OBSLEDOVANIE PUTEM NABLIUDENII, OBSERVATSIONNOE ISSLEDOVANIE, ОБСЕРВАЦИОННОЕ ИССЛЕДОВАНИЕ, NEEKSPERIMENTAL'NOE ISSLEDOVANIE, ОБСЛЕДОВАНИЕ ПУТЕМ НАБЛЮДЕНИЙ, НЕЭКСПЕРИМЕНТАЛЬНОЕ ИССЛЕДОВАНИЕ

Ontology: Intention to Treat Analysis (C2718028)

Definition (MSH) Strategy for the analysis of RANDOMIZED CONTROLLED TRIALS AS TOPIC that compares patients in the groups to which they were originally randomly assigned.
Concepts Research Activity (T062)
MSH D057194
English Intention to Treat Analysis
French Analyse de l'intention de traiter
German Intention-to-Treat Analyse
Italian Analisi per intenzione di trattamento
Portuguese Análise de Intenção de Tratamento, Análise de Intenção de Tratar
Spanish Análisis de Intención de Tratar
Russian ANALIZ DANNYKH NA OSNOVE INTENTION TO TREAT, ANALIZ DANNYKH "NAMERENIIA LECHIT'", АНАЛИЗ ДАННЫХ, ИТОГИ СЛУЧАЙНОЙ ВЫБОРКИ ВСЕХ ПАЦИЕНТОВ, ANALIZ DANNYKH, ITOGI SLUCHAINOI VYBORKI VSEKH PATSIENTOV, АНАЛИЗ ДАННЫХ "НАМЕРЕНИЯ ЛЕЧИТЬ", АНАЛИЗ ДАННЫХ НА ОСНОВЕ INTENTION TO TREAT, АНАЛИЗ РЕЗУЛЬТАТОВ ВСЕХ ВКЛЮЧЕННЫХ ПАЦИЕНТОВ, ANALIZ DANNYKH VSEKH PATSIENTOV, АНАЛИЗ ДАННЫХ ВСЕХ ПАЦИЕНТОВ, ANALIZ REZUL'TATOV VSEKH VKLIUCHENNYKH PATSIENTOV
Czech analýza podle původního léčebného záměru, analýza záměru léčit
Swedish Behandlingsavsiktsanalys
Polish Analiza ITT, Analiza Intention to treat
Norwegian Behandlingsintensjonsanalyse

Ontology: Propensity Score (C2718044)

Definition (MSH) Conditional probability of exposure to a treatment given observed covariates.
Concepts Quantitative Concept (T081)
MSH D057216
English Scores, Propensity, Score, Propensity, Propensity Score, Propensity Scores
French Score de propension
German Propensity Score
Italian Indice di propensione
Portuguese Pontuação de Propensão, Escore de Propensão, Índice de Propensão
Spanish Puntaje de Propensión
Russian ПОКАЗАТЕЛЬ ПРЕДРАСПОЛОЖЕННОСТИ БОЛЬНОГО К ЛЕЧЕНИЮ, POKAZATEL' PREDRASPOLOZHENNOSTI BOL'NOGO K LECHENIIU, ПРЕДРАСПОЛОЖЕННОСТЬ БОЛЬНОГО К ЛЕЧЕНИЮ, ОЦЕНКА, PREDRASPOLOZHENNOST' BOL'NOGO K LECHENIIU, OTSENKA
Swedish Benägenhetspoäng
Polish Wskaźnik skłonności
Czech propensity skóre, tendenční skóre
Norwegian Tilbøyelighetsscore, Tilbøyelighetsskår

Ontology: Run-in Period (C3274438)

Definition (NCI) A period in a clinical study that occurs before the commencement of the primary clinical study investigation, during which subjects may be assessed for suitability in the clinical study, withdrawn from existing therapy, trained in study methodology or evaluated for any other protocol-specified reason.
Definition (NCI_CDISC) A period in a clinical study that occurs before the commencement of the primary clinical study investigation, during which subjects may be assessed for suitability in the clinical study, withdrawn from existing therapy, trained in study methodology or evaluated for any other protocol-specified reason.
Concepts Temporal Concept (T079)
English Run-in Period, RUN-IN