Wiley Encyclopedia of Clinical Trials

Wiley Encyclopedia of Clinical Trials

Online ISBN: 9780471462422

DOI: 10.1002/9780471462422

About this Book

Welcome to the Wiley Encyclopedia of Clinical Trials , the online site for the definitive reference on all facets of clinical trials.

Here you'll find more than 450 entries from the world's leading experts in the field on the basic concepts, methodologies, and applications in clinical trials. The range of topics includes: basic statistical concepts, design and analysis of clinical trials, ethics, regulatory issues, and methodologies for clinical data management and analysis.

How to cite an article from Wiley Encyclopedia of Clinical Trials:
Last name, First (Article Pub Date). Article Title. In: Publication Title, (Editor in Chief.) Hoboken: John Wiley & Sons, Inc., link formatted as dx.doi.org/ Example: Benson, Lisa (April 14, 2006). Accelerometers. In Wiley Encyclopedia of Biomedical Engineering (Metin Akay, ed.) Hoboken: John Wiley & Sons, Inc., dx.doi.org/10.1002/9780471740360.ebs0002

Topical Outline of Contents

Clinical Data Management

  • Annotated Case Report Form
  • Audit Trail
  • Bridging Data Package
  • Case Report Form
  • Central Laboratory
  • Clinical Data Coordination
  • Clinical Data Management
  • Coding
  • Coding Symbols for a Thesaurus of Adverse Reaction
  • Data
  • Data Audit
  • Data Clarification Form
  • Data Cleaning
  • Data Entry
  • Data Monitoring
  • Data Processing
  • Data Quality Assurance
  • Data Validation
  • Database
  • Database Close
  • Database Freeze
  • Database Lock
  • Database Platform
  • Database Programming
  • Database Transfer (e.g., from Oracle Clinical to SAS)
  • Dataset
  • Derived Variables
  • Direct Access
  • Double Data Entry
  • Edit Checks
  • Edit Specifications
  • Electronic Data Capture
  • Error Rate (Database Audit)
  • Faxing Data
  • Foreign Clinical Data
  • Interactive Voice Randomization System (IVRS)
  • International Classification of Disease
  • Manual Data Entry
  • Monitoring Report
  • Optical Character Recognition
  • Optical Mark Recognition
  • Original Medical Record
  • Patient Identification Number
  • Quality Assessment of Clinical Trials
  • Queries
  • Remote Data Capture
  • Single Data Entry
  • Software for Data Management
  • Source Data
  • Source Documents
  • Tracking System
  • Area Under the Curve
  • Bioavailability
  • Bioequivalence
  • Clinical Pharmacology
  • Continual Reassessment Method (CRM)
  • Crossover design
  • Dosage
  • Dosage Form
  • Dose
  • Dose Escalation Design
  • Dose Regimen
  • Forced Dose-Escalation Design
  • Half Life
  • Individual Bioequivalence
  • Maximum Concentration
  • Maximum Duration Trial
  • Maximum Information Trial
  • Maximum Tolerable Dose (MTD)
  • Nonclinical Study
  • Pharmacodynamic Study
  • Pharmacokinetic Study
  • Phase I Trials
  • Phase I/II Trials
  • Population Bioequivalence
  • Population Pharmacokinetic Methods
  • Stability
  • Therapeutic Dose Range
  • Time of Maximum Concentration
  • Adaptive Randomization
  • Allocation Concealment
  • Assessment Bias
  • Baseline Adaptive Randomization
  • Block Randomization
  • Cluster Randomization
  • Dose Escalation Trials
  • Dose-response trial
  • Exploratory Analysis
  • Exploratory Trials
  • Group-Randomized Trials
  • Methods for Conduct of Rigorous Group-Randomization
  • Minimum Effective Dose (MED)
  • Multicenter Trial
  • Patient Population
  • Phase II Trials
  • Phase II/III Trials
  • Planning a Group Randomized Trial
  • Random Allocation
  • Randomization Codes
  • Randomization Envelopes
  • Randomization Methods
  • Randomization Models
  • Randomization Procedures
  • Randomization Schedule
  • Response Adaptive Randomization
  • Simple Randomization
  • Stratified Randomization
  • Sub-population
  • Titration Design
  • Accrual
  • Accrual Rate
  • Active-Controlled Trial
  • Adaptive Design
  • Adequate and Well-Controlled Trial
  • Adherence
  • Alpha penalty
  • Alpha-spending function
  • Analysis Population
  • Assay Sensitivity
  • Assessment of Health-Related Quality of Life
  • Balanced Design
  • Balanced Incomplete Block Design
  • Benefit/Risk Assessment
  • Biased-coin Randomization
  • Blinding
  • Blocking
  • Combination Drug Products
  • Combination Therapy
  • Combination Trials
  • Community Intervention Trials
  • Comparative Trials
  • Comparator (Product)
  • Completer Analysis
  • Compliance
  • Composite Variables (Endpoints or Indices)
  • Conditional Power
  • Confirmatory Analysis
  • Confirmatory Trials
  • Control
  • Control Groups
  • Covariates
  • Cutoff Design
  • Double Dummy
  • Downside Sensitivity
  • Dropin
  • Dropout
  • Effect Size
  • Eligibility
  • Endpoint
  • Enrichment Design
  • Enrollment
  • Equivalence Limit
  • Equivalence Trial
  • Ethnic Factors
  • Evaluable Population
  • Full Analysis Set
  • Futility Analysis
  • Global Assessment Variables
  • Gold Standard
  • Group Sequential Designs
  • Higher Order Crossover Design
  • Historical Control
  • Hypothesis
  • Inclusion Criteria
  • Intention-to-Treat Analysis
  • Interim Analysis
  • Large Simple Trials
  • Longitudinal Data
  • Lost-to-Follow-Up
  • Masking
  • Medical Imaging
  • Minimization Randomization Method
  • Monotherapy
  • Multinational (Global) Trial
  • Multiple Endpoints
  • Multiple Evaluators
  • Multiple Placebos
  • Non-inferiority Trial
  • Non-randomized Trial
  • Objectives
  • Pain Intensity Scale
  • Parallel Group Design
  • Parameter
  • Partially Blinded
  • Per Protocol Set Analysis
  • Phase III Trials
  • Pivotal Trial
  • Placebo
  • Placebo Effect
  • Placebo-Controlled Trial
  • Population
  • Power
  • Predicting Random Effect in Community Intervention
  • Prevention Trials
  • Primary Efficacy Endpoint
  • Primary Hypothesis
  • Primary Objectives
  • Primary Prevention Trials
  • Protocol Deviations
  • Quality of Life
  • Repeatability
  • Reproducibility
  • Run-in Period
  • Sample Population
  • Sample Size for Comparing Means (Superiority and Non-Inferiority)
  • Sample Size for Comparing Proportions (Superiority and Non-Inferiority)
  • Sample Size for Comparing Time-to-Event Data (Superiority and Non-Inferiority)
  • Sample Size for Comparing Variabilities
  • Sample Size Re-estimation
  • Screening
  • Secondary Efficacy Endpoints
  • Secondary Prevention Trials
  • Staggering Entry
  • Standard Care
  • Stopping Boundaries
  • Subgroup
  • Subset
  • Superiority Trial
  • Surrogate Endpoints
  • Target Population
  • Tertiary Endpoints
  • Therapeutic Equivalence
  • Therapeutic Index
  • Therapeutic Window
  • Treatment Group
  • Trial Monitoring (Study Conduct)
  • Unblinding
  • Using Internet in Community Intervention Studies
  • Visual Analog Scale
  • Washout Period
  • Withdrawal from Study
  • Withdrawal from Treatment
  • Cochrane Collaboration
  • Cohort vs. Repeated Cross-Sectional Survey Designs
  • Cost-benefit Analysis
  • Cost-minimization Analysis
  • Label Comprehension Study
  • Observational Trials
  • Open-Labeled Trial
  • Outcomes
  • Outcomes Research
  • Pharmacoeconomics
  • Phase IV Trials
  • Post-Marketing Surveillance
  • Preference Trials
  • Prognostic Factors
  • Publication Bias
  • Registry Trials
  • 510K
  • Angiographic Data
  • Device Registry Trials
  • Diagnostic Studies
  • False Positive - False Negative
  • Feasibility Trials
  • Investigational Device Exemptions (IDE)
  • Major Adverse Cardiovascular Event (MACE)
  • Poolability of Multiple Control Groups
  • Pre-Market Approval of Medical Devices (PMA)
  • Screening Clinical Trials
  • Single Arm Trials
  • Absolute Risk Reduction
  • Additivity
  • Analysis Data Set
  • Analysis of Covariance (ANCOVA)
  • Analysis of Variance (ANOVA)
  • Bayesian Approach
  • Bonferroni Adjustment
  • Bootstrapping
  • Categorical Variables
  • Censoring
  • Change from Baseline
  • Clinical Trial Simulation
  • CMH Test
  • Collinearity
  • Comparing Means
  • Comparing Proportions
  • Comparing Time to Events
  • Comparisonwise Error Rate
  • Completer Analysis
  • Confidence Interval
  • Confounding
  • CONSORT
  • Contrast
  • Correlation
  • Cost-Effectiveness Analysis
  • Cox Proportional Hazard Model
  • Critical Value
  • Cronbach's Alpha
  • Data Mining
  • Data Mining of Health System Data
  • Descriptive Statistics
  • Discriminant Analysis
  • Drift (For Interim Analysis)
  • Equivalence Analysis
  • Estimation
  • Experimentwise Error Rate
  • Factorial Designs
  • Fisher's Exact Test
  • Flexible Design
  • Frailty Models
  • Frequentist Methods
  • Generalized Estimating Equations
  • Generalized Linear Models
  • Goodness-of-Fit (Distribution)
  • Goodness-of-Fit (Model)
  • Hazard Rate
  • Hazard Ratio
  • Heritability
  • Hypothesis Testing
  • Imputation
  • Interaction (Qualitative and Quantitative)
  • Interrater Reliability
  • Interval Censored
  • Intraclass Correlation Coefficient
  • Intrarater Reliability
  • Kaplan-Meier Plot
  • Kappa Statistic
  • Lan-DeMets Alpha-Spending Function
  • Last Observation Carried Forward (LOCF)
  • Linear Model
  • Logistic Regression Analysis
  • Logrank Test
  • Mann-Whitney Test
  • McNemar’s Test
  • Meta-analysis
  • Missing Values
  • Mixed Effects Models
  • Multiple Comparisons
  • Multiple Testing in Clinical Trials
  • N of 1 Randomized Trial
  • Non-inferiority Analysis
  • Non-inferiority Margin
  • Nonparametrics
  • Odd Ratio
  • One-sided test vs. Two-sided Test
  • Outliers
  • Paired T Test
  • Percent Change From Baseline
  • Permutation Tests in Clinical Trials
  • Propensity Score
  • Putative Placebo Comparison
  • P-value
  • Rank Analysis of Variance
  • Receiving Operating Characteristics
  • Regression
  • Relative Risk
  • Reliability Analysis
  • Repeated Measurements
  • Responder Analysis
  • Risk Ratio
  • Risk Set
  • Risk-Benefit Analysis
  • Sensitivity
  • Significance Level
  • Software
  • Specificity
  • Statistical Significance
  • Stratification
  • Stratified Analysis
  • Subgroup Analysis
  • Survival Analysis
  • Textbooks in Clinical Trials
  • Transformation
  • Treatment Effect
  • Treatment-by-Center Interaction
  • Two-sample T Test
  • Type I Error (False Positive)
  • Type II Error (False Negative)
  • Weighted Kappa
  • Wilcoxon Rank Sum test
  • Wilcoxon Signed Rank test
  • Z-score
  • Adverse Drug Reaction
  • Adverse Event
  • Adverse Event Action Taken (to counteract event)
  • Adverse Event Outcome
  • Adverse Event Relationship to Study Drug
  • Adverse Event Severity
  • Body System Classification
  • Case Series
  • Categorical Shift
  • Clinically Significant Laboratory Abnormalities
  • Common Toxicity Criteria (CTC)
  • Concomitant Medication
  • Consumer's Risk
  • Costart
  • Data and Safety Monitoring Board
  • Data Monitoring Committee
  • Drug-Drug Interaction
  • Drug-Food Interaction
  • Early Termination - Patient
  • Early Termination - Study
  • ECG
  • Expanded Safety (ES) Trials
  • Family History
  • Hematology
  • Included Terms
  • Laboratory Tests
  • MedDRA
  • Medical History
  • Medications
  • MEDWatch
  • Normal Ranges
  • Physical Exam
  • Preferred Terms
  • Prior Medication
  • Safety
  • Safety Pharmacology
  • Serious Adverse Drug Reaction (SADR)
  • Serious Adverse Event (SAE)
  • Shift Analysis
  • Standard Units
  • System Organ Class
  • Tolerability
  • Toxicity
  • Treatment Emergent Adverse Event
  • Unexpected Adverse Drug Reaction
  • Vital Signs
  • WHO MED
  • World Health Organization (WHO)
  • World Health Organization Adverse Reaction Terminology
  • Bioinformatics
  • Cell Line
  • DNA Bank
  • Gene Therapy
  • Genetic Association Analysis
  • Human Genomics
  • Microarray
  • Pharmacogenomics
  • Proteomics
  • Repository
  • Software for Genetics/Genomics
  • Two-stage Genetic Association Studies
  • Abbreviated New Drug Application (ANDA)
  • Accelerated Approval
  • Adverse Event Report System (AERS)
  • Advisory Committee
  • Applicable Regulatory Requirements
  • Audit
  • Audit Certificate
  • Audit Report
  • Biostatistician
  • Blind Readers
  • Blind Review (of Study Report)
  • Bridging Study
  • Canadian Health Protection Branch (HPB)
  • Case Report Form Tabulations
  • Center
  • Center for Biologics Evaluation and Research (CBER)
  • Center for Devices and Radiological Health (CDRH)
  • Center for Drug Evaluation and Research (CDER)
  • CFR 21 Part 11
  • Charters
  • Chemistry, Manufacturing and Controls (CMC)
  • Citizen Petition
  • Clinical Development Plan
  • Clinical Hold
  • Clinical Significance
  • Clinical Trial/Study Conduct
  • Clinical Trial/Study Report
  • Clinician
  • Closed Session/report
  • Code of Federal Regulation (CFR)
  • Co-Investigator
  • Committee for Proprietary Medicinal Products (CPMP)
  • Common Technical Document (CTD)
  • Complete Clinical Data Package (CCDP)
  • Contract Research Organization (CRO)
  • Coordinating Committee
  • Coordinating Investigator
  • Data Listings
  • Documentation
  • Drug Development
  • Drug packaging
  • Drug Supply
  • DSMB
  • Efficacy
  • Electronic Submission of NDA
  • EMEA
  • End of Phase I Meeting (FDA)
  • End of Phase II Meeting (FDA)
  • Essential Documents
  • Establishment License Application (ELA)
  • Evaluator
  • Extrapolation of foreign clinical data
  • FDA Division of Pharmacovigilance and Epidemiology
  • FDA Meetings
  • Federal Register
  • Fileable NDA
  • Financial Disclosure
  • Food and Drug Administration (FDA, USA)
  • Good Clinical Practice (GCP)
  • Good Laboratory Practice (GLP)
  • Good Manufacturing Practice (GMP)
  • Good Programming Practice (GPP)
  • Good Review Practice (GRP)
  • Good Statistics Practice
  • Guidance/guideline
  • In vitro/in vivo Correlation
  • Institution
  • Integrated Summary of Effectiveness Data
  • Integrated Summary of Safety Information
  • Interim Clinical/Statistical Report
  • International Conference on Harmonization (ICH)
  • Investigational New Drug Application (IND)
  • Investigational Product
  • Investigator
  • Investigator Meeting
  • Investigator/Institution
  • Investigator's Brochure
  • Joint IRB
  • Kefauver-Harris Amendment
  • Medical Control Agency (MCA, UK)
  • Ministry of Health and Welfare (MHW, Japan)
  • National Cancer Institute (NCI, USA)
  • National Heart, Lung, Blood Institute (NHLBI)
  • National Institutes of Health
  • New Drug Application (NDA)
  • Open Session/Report
  • Orphan Drugs
  • Over-the-Counter Drug Review
  • Parallel Track Regulation
  • Patient Profiles
  • PDUFA
  • Pharmacoepidemiology
  • Pharmacovigilance
  • Pre-NDA Meeting (FDA)
  • Product License Application (PLA)
  • Protocol
  • Protocol Amendment
  • Protocol Deviators
  • Protocol Review Committee
  • Protocol Violators
  • Quality Assurance
  • Quality Control
  • Refuse to File Letter
  • Regulatory Authorities
  • Sponsor
  • Sponsor-investigator Relationship
  • Spontaneous Reporting System (SRS)
  • Standard Operating Procedures
  • Statistical Analysis Plan (SAP)
  • Steering Committee
  • Subinvestigator
  • Supplemental NDA (SNDA)
  • Table Shells
  • Tables (Statistical Report)
  • Treatment IND
  • Trial Closeout
  • Trial Initiation
  • Trial Site
  • Trial Termination
  • United States Pharmacopedia and National Formulary (USP/NF)
  • Unplanned Analysis
  • Assent
  • Belmont Report
  • Clinical Trial Misconduct
  • Confidentiality
  • Declaration of Helsinki
  • Ethical Challenges Posed by Cluster Randomization
  • HIPPA
  • Hippocratic Oath
  • Incompetent Subjects
  • Independent Ethics Committee (IEC)
  • Informed Consent
  • Informed Consent Form
  • Informed Consent Process
  • Institutional Review Board (IRB)
  • Legally Acceptable Representative
  • Nuremberg Code
  • Patients
  • Proxy
  • Subject/Trial Subject
  • Vulnerable Subjects
  • Well-being of the trial subject
  • AIDS Clinical Trials Group (ACTG)
  • Ambulatory Blood Pressure Measurements (ABPM)
  • Angiotensin Converting Enzyme (ACE) Inhibitors
  • Anti-Infective Trials
  • Apnea Trials
  • Arrhythmia Trials
  • ASCOT Trial
  • Asthma Trials
  • Beta blocker
  • Beta-Blocker Heart Attack Trial (BHAT)
  • Biological Products
  • Bone Mineral Density (BMD)
  • BPH Trials
  • Cardiac Arrhythmia Suppression Trial (CAST)
  • Cardiovascular (CV)
  • Carotene & Retinal Efficiency Trial (caret)
  • Central Nervous System (CNS)
  • COMMIT
  • Community-based Breast and Cervical Cancer Control
  • Continuous Infusion Versus Double-Bolus Administration
  • Cooperative North Scandinavian Enalapril Survival Study
  • Coronary Drug Project
  • Diabetes Control and Complications Trials (DCCT)
  • Diabetes Prevention Program
  • Disease Trials for Anesthetic Drug Product
  • Disease Trials for Anti-Infectious Drug Products
  • Disease Trials for Anti-Viral Drug Products
  • Disease Trials for Blood Products
  • Disease Trials for Cardiovascular Diseases
  • Disease Trials for Coagulation Drugs
  • Disease Trials for Dental Drug Products
  • Disease Trials for Medical Imaging and Radiopharmacological Drug Products
  • Disease Trials for over-the-counter drug products
  • Disease Trials for Vaccine Drug Products
  • Disease Trials on Addiction Diseases
  • Disease Trials on Gastrointestinal Diseases
  • Disease Trials on Neuropharmacological Diseases
  • Disease Trials on Ophthalmologic Diseases
  • Disease Trials on Pediatric Patients
  • Disease Trials on Pulmonary Diseases
  • Disease Trials on Reproductive Diseases
  • Disease Trials on Urological Diseases
  • Eastern Cooperative Oncology Group (ECOG)
  • European Organization for Research and Treatment of Cancer (EORTC)
  • Extracorporeal Membrane Oxygenation (EMCO) Trial
  • Generic Drugs
  • Global Utilization of Strategies to Open Occluded Coro
  • Hamilton Depression Scale
  • Heart Transplant Trials
  • Human Immunodeficiency Virus (HIV) Trials
  • International Study of Infarct Survival (ISIS)
  • Multiple Risk Factor Intervention Trial (MRFIT)
  • National Cooperative Gallstone Study
  • National Institutes of Health Stroke Scale (NIHSS)
  • National Surgical Adjuvant Breast and Bowel Project
  • Nurse Health Study
  • Oncology
  • Over the Counter (OTC) Drugs
  • Physician Health Study (PHS)
  • Postmenopausal Estrogen/Progestin Intervention Trial (PEPI)
  • Premature Ventricular Beat (PVB)
  • Prostate Cancer Prevention Trial
  • Southwest Oncology Group (SWOG)
  • Statins
  • Thalidomide
  • TIMI Trial
  • TNT Trial
  • Trials on Metabolic and Endocrine Diseases
  • UGDP Trial
  • Update in Hyperlipidemia Clinical Trials
  • VA Cooperative Studies Program
  • Vaccine
  • Women’s Health Initiative
  • Accuracy
  • Association
  • Baseline
  • Bias
  • Biostatistics
  • Casual Inference
  • Clinical Research
  • Clinical Trial/Study
  • Content Validity
  • Contract
  • Controlled Clinical Trials
  • Crude Rate
  • Cumulative Rate
  • Demographics
  • Disease Group
  • Dissolution
  • Effectiveness
  • Eradication Rate
  • Evaluability
  • Evaluation
  • External Validity
  • Extrinsic Ethnic Factors
  • Food Effect
  • Heterogeneity
  • Homogeneity
  • Imbalance
  • Incidence Rate
  • Inference
  • Internal Consistency
  • Internal Validity
  • Intervention
  • Intrinsic Ethnic Factors
  • Label
  • Morbidity and Mortality
  • Mortality Rate
  • Pathology
  • Patient Characteristics
  • Physician Desk Reference (PDR)
  • Precision
  • Prevalence Rate
  • Publication
  • Random Number
  • Selection Bias
  • Stability Analysis
  • Stability Study Design
  • Time to Disease Progression
  • Time to Event
  • Translation
  • Treatment
  • Trial
  • Unbiasedness
  • Uncertainty
  • Variability
  • Variance
  • Visits

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