A standardized data model used in the pharmaceutical industry to support the generation of statistical analyses and data visualizations. It facilitates the creation of datasets that are more consistent and easier to interpret.
Adaptive Trial
A clinical trial design that allows for modifications to the trial procedures (like dose adjustments) based on interim results, without undermining the trial’s validity and integrity.
Adverse Event (AE)
Any unfavorable or unintended medical occurrence in a patient or clinical trial participant, which may or may not be related to the investigational product.
Baseline
A starting point used for comparison. In clinical trials, it refers to the initial set of measurements taken at the beginning, before any treatment is given.
Bioavailability
The proportion of a drug or other substance that enters the bloodstream when introduced into the body, indicating how much of the ingested dose is available for activity.
Biomarker
A measurable indicator of a biological state or condition, often used to assess the effects or progress of a disease or treatment.
Biostatistician
A professional who applies statistical methods to biological data, often in the context of medical research or public health.
Blinding
A method to prevent bias by ensuring that neither the participants nor the investigators know who is receiving a particular treatment.
Case Report Form (CRF)
A document used in clinical trials to collect data in a standardized manner.
CDISC (Clinical Data Interchange Standards Consortium)
An organization that develops standards to support the acquisition, exchange, submission, and archive of clinical research data.
Clean Patient Data
In the realm of clinical research, having “Clean Patient Data” is paramount. This means that the data derived from patient records, observations, and interventions is not only accurate but also free from errors or inconsistencies. Ensuring data cleanliness ensures that conclusions drawn are valid and trustworthy.
Clinical Research Coordinator (CRC)
An individual responsible for organizing and managing the daily activities of a clinical trial.
Clinical Trail Title
This denotes the distinctive name or heading given to a specific clinical trial. It encapsulates the essence and main focus of the trial, ensuring that potential participants, researchers, and stakeholders understand the primary objective or medical issue being investigated. A well-constructed title offers clear insight without ambiguity.
Comparator
A treatment or standard used as a reference in a clinical trial.
Control Group
A group in a study that receives no treatment, a standard treatment, or a placebo, against which the experimental group is compared.
Cross-over Trial
A type of clinical trial in which participants receive different treatments in a random order.
Data base lock
This is a critical milestone in clinical research. Once a database lock occurs, the collected data gets finalized, indicating no further changes or edits are permissible. This ensures the integrity of the results and facilitates the subsequent stages of data analysis.
Data Monitoring Committee (DMC)
An independent group of experts that monitors patient safety and treatment efficacy data while a clinical trial is ongoing.
Disposition
In a clinical study, disposition refers to the ultimate outcome or status of every participant. This can include details like whether a participant completed the trial, withdrew early, experienced specific adverse events, or was lost to follow-up.
Dose-limiting Toxicity (DLT)
Refers to the most severe side effect caused by a drug, which determines the maximum dose that can be administered safely. It’s crucial in clinical trials to identify the highest dose without causing unacceptable side effects.
Dose-response Study
A study that examines the changes in effects as the dose changes. It helps in understanding the relationship between the amount of drug and the observed effect.
Double-blind Study
A research method where both participants and researchers are unaware of who receives the treatment, eliminating bias.
Dropout
Refers to participants who start but don’t complete a study, affecting the study’s validity.
DSUR (Development Safety Update Report)
A periodic report submitted during clinical trials, detailing the safety profile of a drug.
EDC (Electronic Data Capture)
A system that collects clinical trial data electronically, replacing paper-based data collection.
Efficacy
The ability of a drug or treatment to produce the desired therapeutic effect.
Eligibility Criteria
Set of guidelines determining who can participate in a study, ensuring safety and reliability.
EMEA
The European Medicines Agency (EMEA) plays a crucial role in the medical landscape of the European Union. It’s responsible for the evaluation and supervision of medicinal products, ensuring that they are safe, effective, and of high quality for European citizens.
Endpoint Adjudication
A process where a committee reviews and confirms the accuracy of trial endpoints, ensuring consistency and reliability.
Endpoint
A primary outcome used to judge the effectiveness of a treatment in clinical trials.
Enrolled Subjects
These are individuals who have been officially registered to participate in a clinical study. They have passed initial screenings and have consented to be a part of the trial, thus contributing to the research process.
EudraCT (European Clinical Trials Database)
A centralized European database for all interventional clinical trials on medicinal products authorized in the European Union (EU). It serves as a reference for regulatory oversight and public information.
Exclusion Criteria
Specific conditions or factors that prevent an individual from participating in a clinical trial. These criteria ensure the safety of participants and the validity of the study results.
Exploratory Trials
Early-phase trials aiming to identify potential therapeutic effects, dosing, and safety of a drug or intervention.
FDA (Food and Drug Administration)
A U.S. government agency responsible for protecting public health by ensuring the safety, efficacy, and security of drugs, medical devices, and the food supply.
FIR
The Final Investigation Report, commonly abbreviated as FIR, is an exhaustive document detailing the findings of a research project. It offers insights into methodologies, data analysis, conclusions, and possible implications or recommendations based on the research.
Follow-up
The process of monitoring participants after a clinical trial has ended to observe long-term outcomes and any potential side effects.
Formulation
The composition process where different chemical substances, including the active drug, are combined to produce a final medicinal product.
Full Analysis Set
Represents the maximum set of data from which to derive the primary and secondary endpoint variables as per the trial’s protocol.
Generic Drug
A medication that is equivalent to a brand-name product in dose, strength, route of administration, quality, and intended use, but does not carry the brand name.
Genotyping
The process of determining differences in the genetic make-up (genotype) of an individual by examining their DNA sequence.
Good Clinical Practice (GCP)
An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials involving human subjects.
Good Manufacturing Practice (GMP)
A system ensuring products are consistently produced and controlled according to quality standards. It minimizes risks involved in pharmaceutical production that cannot be eliminated through testing the final product.
HAQ
The Health Assessment Questionnaire (HAQ) is an instrumental tool in gauging health outcomes, especially in chronic diseases. It evaluates a patient’s health status, quality of life, and functional ability, providing valuable feedback for clinicians.
Hazard Ratio
A measure of how often a particular event happens in one group compared to another, over time.
Human Subject
An individual who participates in research, either as a recipient of a test article or as a control.
Hypothesis Testing
A statistical method to test the validity of a hypothesis.
Hypothesis
A proposed explanation for an observed phenomenon, which can be tested.
ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)
A global body promoting harmonized standards for drug development and registration.
IND (Investigational New Drug)
An application to the FDA to begin human clinical trials for a new drug.
Informed Consent
A process ensuring research participants are aware of risks and benefits before participating.
Institutional Review Board (IRB)
A committee ensuring research is ethical and the rights of participants are protected.
Intent-to-treat (ITT)
An analysis including all participants in a trial, regardless of whether they completed it.
Intervention Model
A strategy used in clinical trials to determine the procedure each participant will undergo. It defines the sequence, timing, and combination of treatments given to participants.
Investigational New Drug (IND)
An application submitted to the FDA before human drug testing. It ensures safety and outlines the study’s plan.
IVRS (Interactive Voice Response System)
A phone-based system allowing participants to report data or receive instructions in clinical trials.
IWRS (Interactive Web Response System)
An online version of IVRS, facilitating data collection and trial management.
Kaplan-Meier Estimate
A statistical method estimating the time-to-event data, like survival rates.
Kinetics
The study of the rates at which processes occur, often used in drug metabolism.
Knockout
A technique in molecular biology where a specific gene is made inoperative, often to study the gene’s function. The organism with the inoperative gene is referred to as a ‘knockout organism’.
Latent Period
The time between exposure to a causative agent and the onset of symptoms or disease. It’s a silent phase where no signs are evident.
Lead Compound
A chemical compound that shows promise for potential drug development after initial testing.
Lead Investigator
The primary person responsible for the conduct and management of a clinical trial or research study.
Masking
A method in clinical trials where participants and/or researchers do not know which treatment is being given to prevent bias
Meta-analysis
A statistical technique that combines results from multiple studies to provide a comprehensive overview of a particular topic or question.
Modified Intent-to-treat (MITT)
An analysis based on participants who meet certain criteria, often used in clinical trials to assess treatment effectiveness.
Multicentre Trial
A clinical trial conducted at several different locations or centers to increase the number of participants and enhance the study’s validity.
Multivariate Analysis
A statistical technique used to examine the relationships between multiple variables simultaneously. It helps in understanding the complex interdependencies among variables and can be used in various fields like economics, biology, and social sciences.
NDA (New Drug Application)
A formal step in the drug approval process in the U.S. where manufacturers seek the FDA’s permission to market a new drug for specific indications.
Non-inferiority Trial
A type of clinical trial designed to demonstrate that a new treatment is not significantly worse than an existing treatment in terms of efficacy.
Non-parametric Test
A statistical test that doesn’t assume a specific distribution for the data. It’s useful when data doesn’t meet the assumptions of parametric tests, like normal distribution.
Non-responder
An individual who doesn’t show a significant clinical improvement after receiving a treatment.
Null Hypothesis
A statistical hypothesis that assumes no significant difference or effect. It’s a starting point in hypothesis testing and is tested against an alternative hypothesis.
Objective Response Rate (ORR)
A measure in clinical trials that represents the proportion of patients with a reduction in tumour size or disease progression.
Observational Study
A type of study where researchers observe and collect data without intervening or altering conditions. It’s used to identify patterns, trends, and correlations.
Open-label Trial
A clinical trial where both the researchers and participants know which treatment is being administered. It contrasts with double-blind trials where such information is concealed.
Orphan Drug
A drug developed specifically to treat a rare medical condition, the condition itself being referred to as an ‘orphan disease’. Due to limited potential for profitability, incentives are provided to encourage development.
Output Delivery System (ODS)
A feature in software that allows users to export data and results in various formats, enhancing report generation and presentation.
Parallel-group Design
A clinical trial design where two or more groups of participants receive different treatments or interventions simultaneously for comparison.
Patient-reported Outcome (PRO)
Feedback directly from patients about their health, quality of life, or functional status associated with healthcare or treatment.
Pharmacodynamics
The study of the biochemical and physiological effects of drugs on the body and the mechanisms of their action.
Pharmacovigilance
The science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
Phase I
The first stage in drug testing in human subjects, primarily to assess safety, dosage, and side effects.
Phase II
The second phase of clinical trials that assesses drug efficacy and side effects in a larger group of people.
Phase III
The third phase of clinical trials, conducted on large groups of people to confirm effectiveness, monitor side effects, and compare it to commonly used treatments.
Phase IV
Trials conducted after a drug is already marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.
Placebo comparator arm
This is a segment of a clinical trial where participants receive a placebo instead of the active treatment. The results from this group are used to contrast with those receiving the actual treatment, shedding light on the real effects of the intervention.
Placebo
Within clinical trials, a placebo serves as an inert substance or treatment without any therapeutic effect. It’s used as a control to compare against the actual drug or treatment, ensuring that results are due to the intervention and not psychological effects.
Primary completion date
This pivotal date in clinical research marks when all enrolled participants have finished their prescribed interventions, and the primary outcome has been evaluated. This doesn’t necessarily signify the end of the trial but is a key milestone, especially for preliminary data analysis.
Primary outcome measure
clinical studies vary in their nature and objectives. The study type classifies the trial as observational, interventional, or other formats, giving a glimpse into its structure and intent.
Primary purpose
At the heart of every clinical study lies its primary purpose. This defines the main intent or objective of the trial, whether it’s to assess safety, efficacy, diagnostic capabilities, or preventative potential of a treatment or intervention.
Principal investigator (PI)
This individual is the backbone of the research study. As the lead scientist or researcher, the PI is responsible for the design, conduct, oversight, and overall execution of the clinical trial. Their expertise ensures that the study adheres to ethical guidelines and scientific rigor.
Protocol
The lifeblood of a clinical trial, the protocol is a comprehensive document outlining the study’s objectives, design, methodology, statistical considerations, and more. It ensures all involved parties, from researchers to participants, have a clear understanding of the trial’s processes and expectations.
PSUR
Standing for Periodic Safety Update Report, PSUR is a regulatory document crafted to provide an updated and comprehensive overview of a drug’s safety profile. It helps regulatory agencies assess ongoing risks and benefits during the post-marketing phase.
Quality control (QC) review
A rigorous process in clinical research, the QC review ensures that the study’s data maintains integrity and accuracy. By cross-checking and validating data, any discrepancies or anomalies can be identified and rectified, guaranteeing the reliability of results.
Randomized allocation
Fundamental to many clinical trials, randomized allocation is the process of randomly assigning participants to various study groups. This randomness ensures that any biases, known or unknown, are evenly distributed, allowing for a fair comparison between groups.
Recruitment status
Reflecting the current phase of participant enrolment, recruitment status can indicate if a study is actively seeking participants, if enrolment is closed, or if the study is no longer recruiting due to other reasons.
Results first posted with QC comments
Beyond just presenting the findings, this provides initial results paired with comments from a quality control review. This added layer offers insights into the data’s reliability, potential issues, or considerations.
Results first posted
This signifies the date when the initial findings of the trial are made publicly available. Transparency is crucial in clinical research, and posting results ensures the broader community can assess, learn from, and build upon the findings.
Screen failure
Within the context of clinical trials, a screen failure occurs when a potential participant does not meet the study’s inclusion criteria. Reasons could range from age, medical history, or specific conditions that make participation unsafe or unsuitable.
Screening
An initial phase in clinical trials, screening involves assessing potential participants against a set of predefined criteria. This ensures that those enrolled are suitable for the study, ensuring their safety and the validity of the results.
Secondary outcome measure
While the primary outcome measure captures the trial’s main objective, secondary outcome measures delve into additional metrics or effects. These can shed light on other benefits, side effects, or insights that weren’t the primary focus but are still of interest.
Serious adverse event
In clinical research, an adverse event becomes “serious” when it results in significant health consequences such as hospitalization, disability, or even death. Monitoring and reporting these events are critical for assessing a treatment’s safety profile.
Sham comparator arm
Similar to a placebo comparator arm, this group in a clinical trial receives a faux treatment. However, a sham treatment often mimics the procedure or experience without the active components, ensuring results aren’t skewed by participant expectations.
Single group assignment
Some clinical studies use only one group of participants without any control or comparator group. All participants receive the treatment or intervention, and results are analysed based on this singular group’s experiences.
Sponsor
Every clinical trial requires funding and oversight, roles often played by the sponsor. This can be a pharmaceutical company, academic institution, or other organizations interested in the research’s outcome.
Statistical analysis plan (SAP)
This document outlines the detailed strategies and techniques for analysing the data from a clinical trial. It ensures the data’s examination aligns with the study objectives and adheres to statistical best practices.
Status
The current phase or stage of a study, whether it’s in planning, ongoing, completed, or terminated, is denoted by its status. This helps stakeholders gauge the progress and anticipate the next steps.
Study completion date
A significant milestone, the study completion date marks when all activities, including follow-ups, are wrapped up. From this point, the focus typically shifts to data analysis and reporting.
Study design
Acting as the blueprint, the study design encompasses the trial’s overall methodology and structure. It details elements like the number of participants, duration, interventions, and how data will be collected and analysed.
Study documents
These encompass all written materials linked to the trial. From initial proposals and protocols to participant consents and data sheets, these documents ensure a comprehensive record of the research process.
Study IDs
Every clinical trial is assigned unique identification codes. These codes help distinguish each trial, facilitating easy referencing and ensuring distinctness in large databases.
Study record
This detailed documentation paints a comprehensive picture of the research process, from inception to conclusion. It’s crucial for transparency, replication, and regulatory compliance.
Study results
Derived from the research data, these findings convey the outcomes of the trial. They indicate whether the intervention was successful, provide insights into side effects, and guide future research or medical decisions.
Study start date
This date heralds the official commencement of the clinical trial. It’s when interventions begin, and data collection gets underway.
Study type
Clinical studies vary in their nature and objectives. The study type classifies the trial as observational, interventional, or other formats, giving a glimpse into its structure and intent.
U.S. Agency for Healthcare Research and Quality (AHRQ)
This federal agency has a mission to improve the quality, safety, efficiency, and effectiveness of healthcare across the United States. Through research and evidence generation, the AHRQ supports decisions that enhance healthcare outcomes.
