I have prepared a list of terms used in clinical research with explanations, which may help those interested in clinical research to understand the basic concepts:
Adverse Event (AE): Adverse event. Any unwanted and unexpected medical event that occurs in a participant during a trial.
Adverse Drug Reaction (ADR): Adverse drug reaction. Harmful and unwanted side effects that occur after the use of a medication.
Adverse Clinical Event (ACE): Adverse clinical event. Unexpected medical events that occur in a patient as a result of a treatment or intervention.
Absorption, Distribution, Metabolism, Excretion (ADME): Absorption, distribution, metabolism and excretion. Processes that describe how a drug acts after it is taken into the body.
Acceptable Daily Intake (ADI): Acceptable daily intake. The amount of a substance to which a person can be exposed on a daily basis over a lifetime.
Active Control: Active control. The standard treatment used to measure the effectiveness of experimental treatment in a clinical trial.
Acute Toxicity: Acute toxicity. Toxic effects of a substance resulting from short-term exposure.
Adjuvant Therapy: Adjuvant treatment. Treatment added to support the main treatment.
Application Dossier: Application Dossier. Documents containing the information required for clinical trials and submitted to the competent authorities.
Arm: Treatment group. A group in which participants in a clinical trial are allocated to receive different treatments or placebo.
Baseline Characteristics: Baseline characteristics. The condition or characteristics of participants in a clinical trial before they start treatment.
Bioavailability: A term that measures how much of a drug is absorbed and effective in the body.
Biomarker: Biomarker. A biological indicator that may indicate the presence of a disease or response to treatment.
Blinding: Blinding. When participants or researchers do not know who is receiving which treatment.
Case Report Form (CRF): Case report form. A document recording the data collected for each participant in a clinical trial.
Clinical Endpoint: Clinical endpoint. A criterion set to evaluate the effectiveness of a treatment or intervention.
Clinical Research Associate (CRA): Clinical research assistant. A specialist who works to ensure that clinical trials are conducted correctly.
Clinical Research Coordinator (CRC): Clinical research coordinator. The person responsible for the organization, coordination and management of clinical research.
Clinical Trial: Clinical research. Research to test the efficacy and safety of a new treatment, drug or intervention.
Cohort: Cohort. A type of study in which a group of people with a particular characteristic or exposure are followed and analyzed.
Compliance. Describes how well participants adhere to the instructions and treatment regimens given during the clinical trial.
Confounding Variable: Confounding variable. A variable that may affect the outcome of the study and lead to incorrect conclusions.
Control Group: Control group. In clinical trials, a group that receives standard treatment or placebo for comparison with the new treatment.
Crossover Study: Crossover study. A research design in which participants receive all treatments by switching to different treatment groups.
Data Safety Monitoring Board (DSMB): Data safety monitoring board. An independent board that conducts data and safety reviews to ensure participant safety in clinical trials.
Double-Blind Study: Double-blind study. A type of clinical trial in which both participants and researchers do not know who is receiving which treatment.
Dropout Rate: Dropout rate. The percentage of participants who did not complete the clinical trial.
Endpoint. In a clinical trial, the point at which a specific outcome or target should be measured.
Efficacy:Effectiveness. A measure of how effective a treatment or intervention is on a particular outcome.
Eligibility Criteria: Participation criteria. The conditions that determine who can or cannot participate in a clinical trial.
Enrollment: Participation. The number of participants included in the clinical trial.
Exclusion Criteria. Conditions that specify the conditions under which an individual cannot participate in a clinical trial.
Experimental Group: Experimental group. The group receiving the new treatment or intervention in the clinical trial.
Follow-Up: Follow-up. The process of monitoring the post-treatment status and health status of participants in clinical research.
Good Clinical Practice (GCP): Good clinical practice. International standards set for the ethical and scientific conduct of clinical research.
Inclusion Criteria: Inclusion criteria. The conditions required for an individual to participate in a clinical trial.
Informed Consent: Informed consent. Participants being informed before participating in a clinical trial and voluntarily agreeing to participate.
Interim Analysis: Interim analysis. Preliminary evaluation before the clinical trial is completed.
Investigator: Investigator. The person who conducts the clinical trial and is responsible for data collection.
Investigational New Drug (IND): Investigational new drug. A drug that is being tested in clinical trials and has not yet been approved.
Institutional Review Board (IRB): Ethics committee. The board that evaluates the ethical and safety appropriateness of clinical trials.
Intention-to-Treat Analysis: Intention-to-treat analysis. Analyzing participants according to their assigned treatment groups.
Intervention: Intervention. The treatment or procedure applied to participants in a clinical trial.
Lead Investigator: The lead investigator. The principal investigator responsible for the overall management of the clinical trial.
Longitudinal Study: Longitudinal study. A type of research in which participants are followed and evaluated over a long period of time.
Meta-Analysis: Meta-analysis. Combining and analyzing the results of more than one clinical trial.
Multicenter Study: Multicenter study. Clinical research conducted in more than one research center.
Non-Inferiority Trial: A non-inferiority study. Research conducted to show that the effectiveness of a new treatment is not inferior to the existing treatment.
Open-Label Study: An open-label study. A clinical trial in which both participants and researchers know who is receiving which treatment.
Outcome. The effects or conditions measured at the end of treatment or intervention in a clinical trial.
Clinical Trial Protocol: A clinical trial protocol. An official document detailing how a clinical trial will be conducted. The protocol includes the purpose of the study, methods, participant criteria and data collection processes.
Cohort Study: Cohort study. An observational study in which a group of people (cohort) with a particular characteristic or condition is followed for a certain period of time.
Comparator: Comparator. In a clinical trial, an alternative treatment, placebo or standard of care used to evaluate the efficacy or safety of the experimental treatment.
Compliance. Refers to the extent to which volunteers participating in the study adhered to the treatment protocol and research instructions.
Confounding Variable: Confounding variable. A factor that may affect the results of the study but is not controlled in the study design.
Cross-Over Study: Crossover study. A study design in which participants receive both treatments by being in both the treatment group and the control group during the research.
Data Safety Monitoring Board (DSMB): Data Safety Monitoring Board. An independent group that reviews ongoing safety and efficacy data from a clinical trial. The board decides whether the study is safe.
Double-Blind Study: A double-blind study. A study in which neither the participants nor the researchers know which treatment they are receiving. This is used to reduce bias.
Efficacy. The ability of a treatment to achieve the desired results under certain conditions.
Endpoint. Measurable outcomes that are the main goal of a clinical trial. For example, criteria such as disease progression and survival can be used to determine the effectiveness of a treatment.
Enrollment: Registration. The process of accepting volunteers participating in a clinical trial. Volunteers are included in the study according to specified criteria.
Exclusion Criteria: Exclusion criteria. Characteristics or conditions that prevent a volunteer from participating in the study. For example, people with a certain disease are not included in the study.
Follow-Up: Follow-up. The process of monitoring the health status of participants in a clinical trial over time.
Good Clinical Practice (GCP): Good clinical practice. An international guideline that defines ethical and scientific standards in the conduct of clinical research.
Inclusion Criteria: Inclusion criteria. The characteristics or conditions required for a volunteer to participate in a study. For example, being within a certain age range.
Informed Consent: Informed consent. The volunteer's agreement to participate in the study after being informed about the purpose, processes, risks and benefits of the research.
Intention-to-Treat Analysis (ITT): Intention-to-treat analysis. A method in which all participants in a study are analyzed according to the treatment group to which they were initially assigned, regardless of whether they have completed treatment.
Investigator's Brochure (IB): Investigator's brochure. A document containing current clinical and preclinical information about the investigational drug or treatment. It provides researchers with comprehensive information about the treatment.
Kaplan-Meier Curve: Kaplan-Meier curve. A graphical method used to show the survival rates of a group of patients over time.
Multicenter Trial: A multicenter study. A clinical trial conducted in more than one clinical center. Such studies usually provide a larger number of participants and increase the generalizability of the results.
Non-Inferiority Trial: A non-inferiority study. A clinical trial to show that the effectiveness of a new treatment is not significantly inferior to an existing treatment.
Open-Label Study: Anopen-label study. A type of clinical trial in which both the participants and the researchers know which treatment they are receiving.
Pharmacodynamics (PD): Pharmacodynamics. The study of how a drug acts in the body and how it causes biological responses.
Pharmacokinetics (PK): Pharmacokinetics. The study of how a drug is absorbed, distributed, metabolized and excreted in the body.
Placebo: Placebo. A substance or treatment that does not contain an active ingredient but is used as a control in clinical trials. A placebo does not treat the disease, but is used to evaluate the treatment effect.
Protocol Deviation: Protocol deviation. During a clinical trial, it is the situation of going beyond the procedures specified in the study protocol.
Randomized Controlled Trial (RCT): Randomized controlled trial. A type of clinical trial in which participants are randomly assigned to treatment or control groups, considered the gold standard.
Risk-Benefit Ratio: Risk-benefit ratio. It is the evaluation of the potential risks of a treatment according to its possible benefits.
Sample Size: Sample size. The number of participants required in a clinical trial. Adequate sample size ensures that the results are statistically significant.
Screening: Screening. The process of tests or assessments to identify suitable participants for the study.
Serious Adverse Event (SAE): Serious adverse event. A medical condition that requires hospitalization of the participant, is fatal or may lead to permanent disability.
Statistical Significance: Statistical significance. A statistical criterion that indicates that a research result is not due to chance.
Stratification. The division of participants into subgroups according to certain characteristics. This helps to evaluate the results more precisely.
Study Arm: Study arm. The group of participants receiving treatment in a clinical trial. There is usually more than one arm, for example a treatment arm and a control arm.
Subgroup Analysis: Subgroup analysis. Analyzing the data of subgroups with a particular characteristic or condition separately. This is done to assess how the treatment works in certain groups.
Surrogate Endpoint: Substitute endpoint. A measure used to quantify the effect of a treatment, replacing the direct clinical outcome. For example, tumor shrinkage can be a surrogate endpoint.
Therapeutic Index: Therapeutic index. A measure that indicates the safe dose range of a drug. A high therapeutic index indicates that the drug is safe.
Tolerability. Refers to how well a treatment is tolerated by participants. The degree of side effects and acceptability of the treatment are assessed.
Treatment Allocation. Refers to how participants are assigned to treatment groups. Randomization is usually part of this process.
Washout Period. The period of time participants wait for the effects of their previous treatment to wear off before starting a treatment.
Withdrawal: Withdrawal. When a participant leaves a clinical trial for any reason.
Interim Analysis: Interim analysis. Preliminary data analysis conducted at a certain point while the study is ongoing. Interim analysis is used to decide whether the study should continue.
Active Ingredient: Active substance. The component of a medicine or treatment that actively treats the disease.
Adverse Event Reporting System (AERS): Adverse event reporting system. A system for reporting side effects of medicines.
Bioequivalence: Bioequivalence. When two drugs have biologically identical effects.
Blinded Endpoint Committee (BEC): Blinded endpoint committee. An independent committee that evaluates the endpoints of a clinical trial and has no knowledge of the treatment.
Bridging Study: A bridging study. Studies conducted to determine treatment efficacy in different populations or conditions.
Case-Control Study: A case-control study. Observational study comparing past exposures of individuals with and without the disease.
Clinical Outcome Assessment (COA): Clinical outcome assessment. Methods used to measure the effect of treatment.
Clinical Significance. The significant and practical impact of a treatment on patient health.
Cohort Effect: Cohort effect. Common effects experienced by a group living in the same period or having similar characteristics.
Comparative Effectiveness Research (CER): Comparative effectiveness research. Studies that compare the effectiveness of different treatments.
Composite Endpoint: A composite endpoint. Combining more than one clinical outcome and using it as a single measure.
Concomitant Medication: Concurrent medication. Other medications taken by participants during the study.
Cumulative Dose: Cumulative dose. The total amount of medication taken during a course of treatment.
Data Lock: Data lock. The locking of clinical trial data before analysis and no further modification.
Data Management Plan (DMP): Data management plan. A plan for collecting, storing and analyzing clinical trial data.
Dose Escalation Study: Doseescalation study. Studies conducted to determine the safe dose range of a drug.
Double-Dummy Technique: Double-lying technique. A method in which blinding is achieved by giving active treatment and placebo to both groups in the study.
Dropout: Leaving the study. Participants leaving the study for any reason.
Efficacy Endpoint: Efficacy endpoint. The final result determined to measure the effectiveness of a treatment.
Electronic Case Report Form (eCRF): Electronic case report form. A form in which clinical trial data are collected electronically.
Extrapolation: Extrapolation. Generalization of clinical trial results to a larger population or different conditions.
First-in-Human (FIH) Study: First study in humans. A clinical trial in which a drug or treatment is tested in humans for the first time.
Health-Related Quality of Life (HRQoL): Health-related quality of life. An assessment that measures the impact of patients' health status on their quality of life.
Hypothesis: Hypothesis. A proposition put forward to be tested in clinical research.
Incidence Rate: Incidence rate. The proportion of the number of new cases in a given population in a given time period.
Independent Data Monitoring Committee (IDMC): Independent data monitoring committee. An independent group that monitors the data safety of a clinical trial.
Interim Report: Interim report. A report containing the results of an interim analysis.
Lost to Follow-Up (LTFU): Loss to follow-up. Loss of participants during the follow-up period.
Marginal Structural Model (MSM): Marginal structural model. Statistical method used to examine complex treatment effects.
Medication Adherence. Participants' use of their medication as recommended.
Medication Error: Medication error. Errors made during medication use.
Non-Compliance. Participants not following the treatment or research protocol.
Open-Label Extension Study: An open-label extension study. A study conducted after a successful double-blind study in which all participants received active treatment.
Overall Survival (OS): Overall survival. The length of time participants survive.
Patient-Reported Outcome (PRO): Patient-reported outcome. Assessments in which patients report their own health status and response to treatment.
Pharmacovigilance (PV): Pharmacovigilance. The process of monitoring and reporting side effects of medicines.
Placebo-Controlled Study: A placebo-controlled study. A clinical trial comparing a new treatment with a placebo.
Preclinical Study: Preclinical study. Animal or laboratory studies conducted prior to human trials.
Primary Endpoint: Primary endpoint. The outcome that is the main goal of a clinical trial.
Protocol Amendment: Protocol change. Changes made to the research protocol.
Protocol Violation: Protocol violation. Acting against the research protocol.
Quality Assurance (QA): Quality assurance. Ensuring that clinical research processes comply with quality standards.
Quality Control (QC): Quality control. The process of ensuring the accuracy and reliability of research data.
Randomization: Randomization. The process of randomly assigning participants to treatment groups.
Recruitment: Recruitment of participants. Finding and recruiting volunteers for clinical research.
Safety Endpoint: Safety endpoint. Criteria set to assess the safety of a treatment.
Screen Failure: Screening failure. Participants found ineligible during the research screening phase.
Serious Adverse Drug Reaction (SADR): Serious adverse drug reaction. Drug side effects that are life-threatening or cause serious health problems.
Single-Blind Study: A single-blind study. A type of study in which only the participants do not know which treatment they are receiving.
Source Data Verification (SDV): Source data verification. Checking the accuracy of clinical trial data against source documents.
Standard of Care: Standard treatment. Generally accepted treatment for a particular disease or condition.
Statistical Power: Statistical power. The probability that a study will detect a real effect.
Study Design: Study design. The way clinical research is planned and conducted.
Study Population: The study population. All participants included in the study.
Survival Analysis: Survival analysis. Statistical method that examines the life expectancy and survival rates of participants.
Toxicology Study: Toxicology study. Studies conducted to examine the harmful effects of a substance.
Treatment Emergent Adverse Event (TEAE): A side effect that occurs during treatment. Undesirable events observed after treatment has started.
Trial Master File (TMF): Study master file. The file where all documents of a clinical trial are stored.
Type I Error: Type I error. The error of accepting as true a hypothesis that is actually false (false positive).
Type II Error: Type II error. Error rejecting as false a hypothesis that is actually true (false negative).
Unblinding: Unblinding. The process of letting participants or researchers know which treatment group they are in.
Validated Instrument: A validated instrument. A measurement tool used in clinical research that has proven reliability and validity.
Washout Period: Washout period. The period of time given before or after the study for the treatment effects to wear off.
Withdrawal Criteria: Withdrawal criteria. Criteria set for the removal of participants from the study.
Adherence: Compliance. Patients' adherence to the treatment plan and medication instructions.
Algorithm: Algorithm. A sequence of steps followed to solve a specific problem.
Anaphylaxis: Anaphylaxis. Serious, life-threatening allergic reaction.
Anticoagulant: Anticoagulant. A drug or substance that prevents blood clotting.
Arrhythmia:Arrhythmia. A condition in which the heart rhythm is irregular.
Biomarker: Biomarker. Biomarker used in the diagnosis and treatment of diseases.
Case Report: Case report. A report detailing the medical history and treatment of a single patient.
Case Series: Case series. A study examining the medical history of a group of patients with similar diseases or conditions.
Clinical Trial Registry: Clinical trial registration system. A system where research is recorded and made publicly available.
Compassionate Use: Compassionate use. Allowing the use of unapproved medicines for patients with serious illnesses.
Contraindication: Contraindication. A condition or situation in which a particular treatment should not be used.
Cross-Over Study: Crossover study. A type of study in which participants are randomly assigned to more than one treatment group and the treatments are switched after a certain period of time.
Endpoint Adjudication Committee (EAC): Endpoint adjudication committee. An independent board that evaluates the results of clinical research.
Follow-Up Study: Follow-up study. A study that monitors the health status of participants after the research.
Good Clinical Practice (GCP): Good clinical practice. The set of rules that set the ethical and scientific standards of clinical research.
Hazard Ratio (HR): Hazard ratio. A statistical measure that compares the proportion of two groups at risk over a given time period.
Investigator's Brochure (IB): Investigator's brochure. A document containing the characteristics and preclinical data of the investigational drug.
Inclusion Criteria: Inclusion criteria. Requirements for participation in the study.
Intent-to-Treat (ITT) Analysis: Intent-to-treat analysis. Data analysis based on the groups assigned at the start of the trial.
Interim Analysis: Interim analysis. Analysis conducted while the research is ongoing and evaluates the initial findings.
Institutional Review Board (IRB): Institutional review board. The board that evaluates the ethical and scientific appropriateness of the research.
Kaplan-Meier Curve: Kaplan-Meier curve. Graphical method showing the results of survival analysis.
Longitudinal Study: Longitudinal study. A type of study in which participants are evaluated repeatedly over a period of time.
Meta-Analysis: Meta-analysis. A method of drawing a general conclusion by combining the results of more than one study.
Non-Inferiority Trial: A non-inferiority study. A study that aims to prove that the new treatment is not worse than the existing treatment.
Observational Study: Observational study. A type of study in which the natural state of participants is examined without intervention.
Outcome Measure: Outcome measure. Criteria used to evaluate the final results of the study.
Patient Consent Form: Patient consent form. A document signed by patients who agree to participate in the study.
Peer Review: Referee evaluation. The process of examining scientific studies by independent experts.
Pharmacokinetics (PK): Pharmacokinetics. The study of how drugs are absorbed, distributed, metabolized and excreted in the body.
Pharmacodynamics (PD): Pharmacodynamics. The field that studies the biochemical and physiological effects of drugs on the body.
Placebo Effect: Placebo effect. The condition in which patients given placebo respond to treatment.
Prospective Study: Prospective study. A prospective study conducted to predict future events.
Protocol Deviation: Protocol deviation. Small deviations from the research protocol.
Randomized Controlled Trial (RCT): Randomized controlled trial. A type of study in which participants are randomized into treatment or control groups.
Relative Risk (RR): Relative risk. Comparison of the probability of a certain event in two different groups.
Retrospective Study: Retrospective study. A retrospective study examining data from the past.
Sample Size: Sample size. The total number of individuals participating in the study.
Sensitivity Analysis: Sensitivity analysis. An analysis that assesses how sensitive research results are to certain assumptions or variables.
Serious Adverse Event (SAE): Serious adverse event. An unwanted event that leads to serious consequences such as hospitalization, permanent disability or death.
Standard Operating Procedure (SOP): Standard operating procedure. Procedures that define how to perform certain tasks.
Statistical Significance: Statistical significance. The condition that the results of a study are unlikely to occur by chance.
Surrogate Endpoint: Indirect endpoint. Interim measures used instead of final clinical outcomes.
Systematic Review: Systematic review. Systematic review and summarization of all available research on a specific topic.
Observational Study: Observational study. A type of study in which researchers only observe the current situation without any intervention with the participants.
Outcome Measure: Outcome measure. Measures used to evaluate the effects of a clinical trial. This is used to assess the effectiveness or safety of treatment.
Pharmacogenomics: Pharmacogenomics. A branch of science that studies the relationship of drugs to the genetic makeup of individuals. It investigates the effects of individual genetic differences on drug responses.
Primary Investigator (PI): The primary investigator. The main investigator responsible for the clinical trial and oversees all aspects of the study.
Randomization. The process of preventing selection bias by randomly assigning participants to treatment groups.
Real-World Evidence (RWE): Real-World Evidence. Refers to data and information that examines the accuracy of findings in clinical trials under real-world conditions .
Safety Monitoring. Continuous monitoring of side effects and adverse events to ensure the safety of participants during the research.
Standard Protocol Operating Procedures (SOPs): Standard Protocol Operating Procedures. Standardized procedures used in the conduct of clinical trials.
Statistical Analysis Plan (SAP): Statistical Analysis Plan. A document detailing the data analysis methods and statistical tests of the study.
Subject Recruitment: Participant recruitment. The process of finding and selecting individuals suitable for the clinical study.
Treatment Group: Treatment group. A group of participants who receive a specific treatment or intervention in a clinical study.
Validation: Verification. Control procedures to ensure that data collection and analysis processes are accurate and valid.
Variance. A statistical term that measures how far the values in a data set deviate from the mean.
Washout Period: Washout period. The period of time participants wait for the effects of their previous treatment to wear off. (This term appears twice in the list, but its importance should be emphasized).
Wellness Visit: A health check visit. Visits where participants' general health and response to treatment are regularly assessed.
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