Clinical Research Glossary Terms: Clinical research as field of study is complex and replete with specialised terminologies. If you are someone who works in the clinical research field, you could already be familiar with the terms. However, there’s nothing to be ashamed about if you don’t know one or two in the clinical research glossary, it happens – and that’s okay!
Why? Because we will help you out there with the essential clinical research terminology list you should be aware of!
This LLRI blog comprises of all the important common clinical research terms, from A to Z – from the glossaries of NIA (Natural Institute of Aging), NIH (National Institutes of Health), MRCT (Multi-regional clinical trials), Novotech and other similar important portals.
We have tried to converge all the important research terms in this glossary of clinical research here within this article on the common clinical research terms, hope this helps you guys understand essential clinical research terminology! Read on….
Glossary Of Clinical Research: A to Z of all the Common Clinical Research Terms
A
- Adverse Event (AE): Any undesirable experience associated with the use of a medical product in a patient. This could be mild, moderate, or severe.
- Amendment: A formal change or addition made to the protocol of a clinical study.
- Assent: Agreement from a participant, often a minor, who is not legally able to give full consent but can understand the study and agree to participate.
B
- Baseline: Initial set of measurements taken at the start of a study before the participant receives any treatment, used for comparison throughout the study.
- Basket Trial: A research study that tests one study treatment for different diseases and conditions.
- Bias: A systematic error or deviation from the truth, in results or inferences, in clinical research.
- Biomarker: Something in the body that is measured as an indicator of personal health or disease.
- Blinding (Masking): A method used to prevent study participants, healthcare providers, and/or researchers from knowing which intervention the participant is receiving to eliminate bias.
- Bioinformatics: The science of using computers, databases, and math to organize and analyze large amounts of biological, medical, and health information. Information may come from many sources, including patient statistics, tissue specimens, genetics research, and clinical trials.
C
- Case Report Form (CRF): A document used to record data on each participant during a clinical trial.
- Clinical Endpoint: A primary outcome used to judge the effectiveness of a treatment.
- Clinical Trial: A research study conducted with human volunteers to evaluate the safety and efficacy of a medical treatment or intervention.
- Cohort: A group of individuals sharing a common characteristic, such as age or treatment, who are followed over a period of time.
Keep reading the essential clinical research terminology below…
D
- Data Monitoring Committee (DMC): An independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.
- Data and Safety Monitoring Plan (DSMP): The DSMP deals with how the framework for safety and data monitoring of the clinical trials is laid out, and other factors such as how adverse events will be reported to the IRB and the NIH and, how the NIH Guidelines and FDA regulations for INDs and IDEs will be applied.
- Double-blind Study: A study in which neither the participants nor the investigators know who is receiving the experimental treatment and who is receiving a placebo.
- Dose-response Relationship: The relationship between the dose of a drug and the magnitude of its therapeutic or adverse effects.
E
- Efficacy: The ability of a drug or treatment to produce the desired beneficial effect in controlled clinical trials.
- Endpoint: A primary or secondary outcome used to assess the effectiveness of a treatment in a clinical trial.
- Epoch: The planned stages of volunteer participation in a trial typically include assessing eligibility, a wash-out period to discontinue any previous treatments, administering the trial treatment, and conducting follow-up after the treatment has concluded.
- Ethics Committee: A group that reviews and monitors biomedical research involving humans, ensuring that the study is ethical, and the rights and welfare of participants are protected.
- Early Phase: Termed as Phase 0 previously, it defines the exploratory trials conducted before traditional phase 1 trials, which aims to explore/investigate how/whether a drug affects the body.
- Eligibility Criteria: These are the key requirements that individuals must meet to participate in a clinical study. Eligibility criteria include both inclusion criteria (which define who can join the study) and exclusion criteria (which specify who cannot participate). These criteria can be based on various factors such as health status, age, sex, or specific medical conditions.
- Enrolment: This refers to the number of participants in a clinical study. The “estimated” enrolment is the target number of participants that researchers aim to recruit for the study.
- Exclusion Criteria: These are specific factors that disqualify a person from participating in a clinical study. Exclusion criteria are a subset of eligibility criteria, ensuring that only suitable participants are included in the research.
- Emergency Use Authorization (EUA): It is the process that makes a vaccine or a treatment available during a public health emergency, for example, COVID-19 vaccines. Under EUA, the vaccine/treatment is made public before all the research is complete, and even before the full approval for its release.
Here are few more essential clinical research terminology for your perusal.
F
- FDA (Food and Drug Administration): The U.S. federal agency responsible for regulating food, drugs, medical devices, cosmetics, and more.
- Feasibility Study: A small-scale study conducted to determine whether a larger study is practical and what modifications may be needed.
- Formulation: The composition of a drug, including its active and inactive ingredients.
G
- Good Clinical Practice (GCP): An international standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.
- Gender-based Eligibility: A type of eligibility criteria that determines participation in a clinical study based on an individual’s self-identified gender. Gender identity refers to a person’s personal sense of gender, which may or may not align with their biological sex.
- Genotype: The genetic makeup of an individual, often studied to understand the impact on drug response.
- Guideline: A document providing principles or recommendations on how to carry out certain tasks or processes in clinical research.
H
- Hypothesis: A proposed explanation made based on limited evidence as a starting point for further investigation in a study.
- Hazard Ratio: A measure used in survival analysis to compare the risk of an event happening in one group versus another.
- Human Subject: An individual who participates in research, either as a recipient of the test article or as a control.
- Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule: It is the first comprehensive Federal regulation safeguarding the privacy of personal health information. This rule governs how specific healthcare groups, organizations, or businesses, referred to as covered entities, manage individually identifiable health information, known as protected health information.
I
- Institutional Review Board (IRB) / Independent Ethics Committee (IEC): An IRB or IEC is a group made up of medical experts, scientists, and non-scientists. Their job is to protect the rights and safety of people participating in clinical trials. They do this by reviewing and approving trial plans and changes and ensuring that the methods used to get and document participants’ consent are appropriate.
- Intervention: An intervention is any procedure or treatment used in clinical research. This could include drugs, supplements, vaccines, behaviour changes, or device modifications.
- Investigational New Drug Application (IND): An IND is a request to the FDA for permission to test a new drug or biological product on humans. This approval is needed before shipping and administering any new drug or product that hasn’t been officially approved yet.
- Inclusion Criteria: The characteristics that must be present for an individual to be eligible to participate in a clinical trial.
- Informed Consent: The process by which a participant voluntarily confirms their willingness to participate in a study after being informed of all aspects that are relevant to their decision to participate.
- Interim Analysis: An analysis of data conducted before the data collection has been completed to assess the safety, efficacy, or other important measures.
- Interventional Study: Also called a clinical trial, this type of study involves participants receiving specific interventions as outlined in the study protocol. Researchers use these interventions to assess their effects on a health condition.
- Investigational Drug: This refers to a drug being tested in a trial. It is also known as an “investigational new drug” or “investigational medicinal product.”
J
- Joint Monitoring: A collaborative effort between different stakeholders to monitor the conduct of a clinical trial, ensuring compliance with protocols and regulations.
- Justification: The reasoning behind certain decisions made during the design or conduct of a clinical trial.
- Journal Publication: The process of publishing the findings of a clinical trial in a scientific journal.
K
- Kaplan-Meier Estimate: A statistical method used to estimate the survival function from lifetime data.
- Key Opinion Leader (KOL): An expert in a particular field whose opinion influences the decisions of others, often involved in clinical research design and analysis.
- Knowledge Transfer: The process of sharing or disseminating knowledge, skills, or technology from one organization or individual to another, especially in clinical research contexts.
Read more on clinical research glossary here……..
L
- Legally Authorized Representative (LAR): A person authorized under applicable law to consent on behalf of a prospective participant to their participation in a clinical trial.
- Longitudinal Study: A study that follows participants over a long period of time to observe changes and long-term outcomes.
- Lost to Follow-Up: A term used when a participant in a clinical study cannot be contacted or does not return for follow-up assessments.
M
- Monitoring: The ongoing oversight of a clinical trial, often involving data review, site visits, and ensuring adherence to the study protocol.
- Meta-Analysis: A statistical method that combines the results of multiple studies to arrive at a conclusion about the body of research.
- Multi-Center Trial: A clinical trial conducted at several different locations (hospitals, clinics, etc.) to increase the generalizability of the findings.
- Manual of Procedures (MOP): An MOP is a set of procedures describing study conduct and is developed to facilitate consistency in protocol implementation and data collection across study participants and clinical sites.
N
- Non-Inferiority Trial: A type of clinical trial conducted to show that a new treatment is not worse than an existing treatment by more than a small, predefined amount.
- NDA (New Drug Application): The application submitted to the FDA for approval to market a new drug in the United States.
- Null Hypothesis: A hypothesis that there is no effect or no difference, often the starting point in statistical testing.
- NCT Number: This is a unique code assigned to each clinical study listed on ClinicalTrials.gov. It starts with “NCT” followed by an 8-digit number, such as NCT00000419.
- No Intervention Arm: This is a type of study group where participants do not receive any treatment or intervention during the clinical trial.
Now, onto the next essential clinical research terminology list – O!
O
- Open-Label Study: A type of study where both the researchers and participants know which treatment is being administered, with no blinding involved.
- Outcome Measure: A measure used to assess the effectiveness of a treatment or intervention in a clinical trial.
- Observational Study: A study in which participants are observed or certain outcomes are measured without treatment being applied by the researchers.
- Other Adverse Event: An adverse event that does not meet the criteria for a serious adverse event. It does not result in death, is not life-threatening, does not require hospitalization or extend an existing hospital stay, does not lead to significant disability or disrupt normal life functions, and does not cause a birth defect or congenital anomaly. It also does not put the participant in immediate danger or require medical or surgical intervention to prevent serious outcomes.
- Other Study IDs: These are identifiers or ID numbers, other than the NCT number, assigned to a clinical study by the sponsor, funders, or other entities. These may include unique identifiers from other trial registries or National Institutes of Health grant numbers.
- Other Terms: In the search feature, the “Other terms” field is used to refine a search. For example, entering the name of a drug or the NCT number of a clinical study can help narrow the search to records containing those specific terms.
P
- Placebo: An inactive substance designed to resemble the drug being tested, used in clinical trials to test the efficacy of the active drug.
- Protocol: A document that describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial.
- Principal Investigator (PI): The person responsible for the conduct of the clinical trial at a trial site, overseeing all aspects of the study.
- Phase: Categories defined by the Food and Drug Administration (FDA) to describe the stages of a drug’s clinical trial. These categories are based on specific characteristics, such as the study’s objective and the number of participants involved. The four phases are Phase 1, Phase 2, Phase 3, and Phase 4.
- Patient Registry: A type of observational study that gathers detailed information about patients’ medical conditions and treatments. This data helps researchers understand how conditions or treatments impact patients in real-world settings.
Q
- Quality Assurance (QA): Systematic activities implemented to ensure that the clinical trial is being conducted in accordance with regulatory requirements and good clinical practice (GCP).
- Query: A request for clarification on specific data points in a clinical trial, often raised during data monitoring or review.
- Quarantine: The isolation of participants or materials suspected of being exposed to or contaminated with infectious agents.
R
- Randomization: The process of assigning trial participants to different treatment groups using random methods, ensuring that each participant has an equal chance of receiving any given treatment.
- Regulatory Authority: Government agencies responsible for overseeing and regulating clinical research, such as the FDA in the United States.
- Risk-Benefit Ratio: The comparison of the risk of harm to the potential benefits of a treatment or intervention in a clinical trial.
- Recruitment Plan: A strategy that details how participants will be selected for the study and the steps that will be taken to achieve the recruitment target.
- Retention Plan: A strategy that outlines the approaches and methods to be used to ensure participants remain engaged and continue their involvement throughout the clinical trial.
Continue reading to learn about more common clinical research terms…
S
- Screening: The process of evaluating potential participants to determine if they meet the eligibility criteria for a clinical trial.
- Serious Adverse Event (SAE): Any undesirable experience that results in death, is life-threatening, requires hospitalization, or causes significant disability/incapacity.
- Site Monitoring Visit: A visit conducted by a monitor to ensure that the study is being conducted properly at the clinical site, adhering to the protocol and regulatory requirements.
- Sham Comparator Arm: A study group where participants receive a procedure or device that mimics the actual treatment being tested but lacks any active components or processes.
- Statistical Analysis Plan (SAP): A detailed document outlining the statistical methods and considerations for analyzing the data gathered during a clinical study.
- Standard Operating Procedures (SOPs): Comprehensive written guidelines designed to ensure consistent execution of specific tasks across various studies and patients at a particular site.
- Stopping Rules: Predetermined safety guidelines that can temporarily suspend or permanently stop a study due to reasons such as futility or potential risks to participants.
- Stratification: The process of dividing a study population into distinct subgroups based on characteristics like age or gender to account for factors that could influence the study’s outcomes.
T
- Treatment Arm: A group or subgroup of participants in a clinical trial that receives a specific treatment or intervention.
- Translational Research: A type of research that aims to translate findings from basic science into practical applications that enhance human health and well-being.
- Trial Master File (TMF): A collection of essential documents that allow the conduct of a clinical trial to be understood and evaluated.
U
- Unblinding: Revealing the treatment assignment to participants, investigators, or both in a clinical trial, usually after the study is completed or at a predetermined time point.
- Underpowered Study: A study with insufficient sample size to detect a statistically significant effect.
- Unanticipated Adverse Device Effects (UADEs): These refer to any unexpected serious adverse effect on health or safety, any life-threatening issue, or any death linked to a medical device.
- Urgent Safety Measure (USM): A measure taken to protect the participants in a clinical trial from an immediate hazard to their health or safety.
V
- Vulnerable Population: Groups of individuals who may be at increased risk of coercion or undue influence in research settings, such as children, prisoners, or individuals with cognitive impairments.
- Voluntary Consent: Consent given freely and without coercion or undue influence, ensuring that participants are participating in a clinical trial of their own free will.
- Vaccine: A biological preparation that provides active acquired immunity to a particular infectious disease.
W
- Washout Period: A period during which participants in a clinical trial do not receive any treatment, used to eliminate the effects of a previous treatment before starting a new one.
- Withdrawal: The removal of a participant from a clinical trial, either by the participant’s choice or by the investigator, often due to safety concerns or non-compliance.
On A Final Note…
Clinical research is an important field that drives medical advancements and improves patient care worldwide. This clinical research glossary provides an overview of essential clinical research terminology key terms from A to Z, helping you navigate the complex landscape of clinical research as well as clinical trials with greater confidence.
As the field of clinical research continues to evolve, staying informed about these common clinical research terms will not only improve your knowledge but also empower you to contribute meaningfully to this area of healthcare.
If you wish to learn more on the same, the next step would be to join a clinical research course which can essentially help you learn in-depth about the common clinical research terms. Click here to know more.