Glossary of clinical research

A glossary of terms used in clinical research.

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Glossary of Clinical Research (Part 1)

• Active placebo – A placebo designed to mimic the side effects of the treatment being studied, without offering therapeutic benefit. Used to maintain study blinding more effectively.

• Adverse event – Any undesirable experience or medical occurrence during a clinical trial, regardless of whether it is related to the investigational treatment.

• AllTrials – A global campaign advocating for the registration and reporting of all clinical trial results to improve transparency and public access to research.

• Analysis of clinical trials – The process of evaluating clinical trial data to determine safety and efficacy outcomes using statistical methods.

• Anne Ferguson (physician) – A noted British physician known for her contributions to gastroenterology and research ethics.

• Approved drug – A pharmaceutical drug that has passed regulatory review (e.g., FDA approval) and is authorized for public use.

• Assay sensitivity – The ability of a clinical trial to distinguish between effective and ineffective interventions.

• Biodistribution – The study of how substances such as drugs spread throughout body tissues and organs after administration.

• Bioequivalence – A measure showing that two drugs release their active ingredients into the bloodstream at the same rate and extent.

• Biomedical Research Center – An institution dedicated to conducting research in biomedicine, often involving clinical and translational studies.

• Blinded experiment – A study design where participants, and sometimes researchers, are unaware of the group assignments to minimize bias.

• COVID-19 drug development – The accelerated process of discovering and evaluating therapies and vaccines for the COVID-19 pandemic.

• Case report – A detailed description of an individual patient’s medical history, diagnosis, treatment, and outcomes, often used to report novel or rare conditions.

• Case report form – A standardized document used to collect clinical data from each participant in a clinical trial.

• Case series – A collection of case reports of patients who have a similar condition or received the same treatment, used in observational studies.

• Castle Connolly Medical – A health organization that identifies and publishes lists of top doctors and institutions in the United States.

• Clinical data acquisition – The collection of accurate and validated clinical data during a trial, typically guided by a protocol.

• Clinical data management system – A software tool used to input, clean, and manage data gathered during clinical studies.

• Clinical endpoint – A measurable outcome used to assess the effectiveness of a treatment, such as survival rate or symptom relief.

• Clinical investigator – A qualified individual responsible for conducting a clinical trial at a specific site in compliance with regulations and ethical standards.

• Clinical research associate – A professional who ensures that a clinical trial is conducted according to the protocol and regulatory guidelines, often through site monitoring.

• Clinical research coordinator – A key team member who manages day-to-day trial operations including patient recruitment, data entry, and regulatory compliance.

• Clinical significance – The practical importance of a treatment effect, meaning how beneficial it is in real-world clinical practice.

• Clinical study design – The blueprint for how a clinical study is conducted, including methodology, timelines, and participant selection.

• Clinical study report – A comprehensive account of a clinical trial's background, methodology, results, and conclusions, used for regulatory submissions.

• Clinical trial – A type of research study that evaluates the safety and efficacy of medical, surgical, or behavioral interventions in humans.

• Clinical trial management system – A platform that helps plan, track, and manage operational aspects of clinical trials such as budgets and schedules.

• Clinical trial portal – An online interface used by researchers, sponsors, or participants to access and manage clinical trial information.

• Clinical trial registration – The public documentation of a clinical trial’s objectives, design, and status in a clinical trial registry before enrollment begins.

• Clinical trials publication – The dissemination of clinical trial results in scientific journals or public databases to inform medical knowledge.

• Clinical trials unit – A dedicated organizational entity within a hospital or academic center responsible for conducting and supporting clinical trials.

• Cluster-randomised controlled trial – A study where groups (rather than individuals) are randomized to different interventions, common in public health research.

• Code-break procedure – The predefined method to reveal a participant’s treatment allocation in a blinded study, typically used in emergencies.

• Common Technical Document – A harmonized format used to submit drug approval information to international regulatory authorities such as the EMA or FDA.

• Community advisory board – A group representing trial participants or affected communities that offers input on trial design and ethical issues.

• Community-based clinical trial – A trial conducted in a community setting, often involving diverse populations and focusing on real world evidence.

• Consecutive case series – An observational study where patients treated in succession under the same protocol are included without exclusion.

• Contract research organization – An external company contracted by sponsors to conduct research services, including trial management and data analysis.

• Core outcome set – A standardized set of outcomes that should be measured and reported in all clinical trials for a specific health condition.

• Crossover study – A clinical trial in which participants receive treatments in a specific order (e.g., treatment A then B), allowing each participant to act as their own control.

• Data clarification form – A document used during data validation to query discrepancies or missing entries in the clinical trial database.

• Data monitoring committee – An independent group of experts who monitor the safety and efficacy of a trial and can recommend early termination if necessary.

• DecodeME – A UK-based clinical study exploring the genetic basis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

• Dynamic treatment regime – A strategy in clinical research where treatment decisions adapt over time based on patient responses.

• Effect size – A statistical measure describing the strength of a treatment effect, often used to interpret clinical importance beyond statistical significance.

• Electronic data capture – The process of entering trial data directly into electronic systems, improving efficiency and data accuracy over paper-based forms.

• Evidence-based medicine – A clinical practice approach that integrates the best current evidence, clinician expertise, and patient values in decision-making.

• Expanded access – A regulatory pathway allowing patients to access investigational therapies outside of clinical trials due to unmet medical needs.

Glossary of Clinical Research (Part 2)

• Good clinical data management practice – Standards and practices aimed at ensuring the integrity, quality, and confidentiality of clinical trial data.

• Good clinical practice – An international ethical and scientific quality standard for designing, conducting, and reporting trials that involve human subjects.

• Haybittle–Peto boundary – A statistical threshold used in interim analyses of clinical trials to determine whether to stop early for efficacy.

• Health services research – A multidisciplinary field studying how healthcare is accessed, its cost, and outcomes, with a goal of improving healthcare systems.

• Hierarchy of evidence – A framework ranking the relative strength of various types of clinical research evidence.

• Hit selection – A phase in drug discovery where potential therapeutic compounds are identified from high-throughput screening.

• Human subject research – Research involving human participants, requiring rigorous ethical oversight and informed consent procedures.

• IDEAL framework – A structured model for evaluating new surgical interventions through Innovation, Development, Exploration, Assessment, and Long-term study stages.

• In silico clinical trials – Simulated trials conducted using computer modeling to predict the behavior of drugs in virtual populations.

• Inclusion and exclusion criteria – The set of predefined characteristics used to determine participant eligibility in a clinical study.

• Informed assent – An agreement to participate in research obtained from individuals (often minors) not legally able to give full informed consent.

• Intention-to-treat analysis – A strategy for analyzing results in clinical trials where all participants are included in the group to which they were originally assigned.

• Interim analysis – The evaluation of trial data at intervals before completion to monitor safety and potential efficacy.

• Investigational New Drug – A drug not yet approved for general use but allowed for clinical investigation by regulatory bodies like the FDA.

• Investigator's brochure – A detailed compilation of clinical and non-clinical data on an investigational product for investigators in a trial.

• Irwin screen – A standardized method for evaluating behavioral and physiological changes in rodents, often used in preclinical testing.

• Jadad scale – A scoring system used to assess the methodological quality of clinical trials, particularly randomized controlled trials.

• James Lind – An 18th-century Scottish physician recognized for conducting one of the first controlled clinical trials.

• Linguistic validation – The process of translating and culturally adapting clinical instruments to maintain their reliability and validity across languages.

• Lost to follow-up – Participants in a clinical trial who are no longer reachable or do not return for evaluation, potentially impacting study results.

• Male contraceptive – Birth control methods or drugs developed for men, which are currently under clinical investigation.

• Medical statistics – The use of statistical methods to analyze and interpret data in medical and clinical research.

• Medical writing – The creation of scientific documentation related to clinical research, including study protocols, reports, and publications.

• Microdosing – Administering subtherapeutic doses of a drug to study its pharmacokinetics in humans, typically in early-phase trials.

• Minimisation (clinical trials) – A method of patient allocation in trials that ensures balanced distribution of participants across treatment groups.

• Mirandola Biomedical District – An Italian hub for biomedical research and manufacturing, especially in medical devices.

• Monitoring in clinical trials – The process of overseeing a clinical trial to ensure that it is conducted according to the protocol, GCP, and regulatory requirements.

• Multicenter trial – A clinical trial conducted at more than one location, increasing generalizability and recruitment rates.

• NHS Research Scotland – A national organization supporting clinical research in Scotland's National Health Service.

• Natural history study – An observational study tracking the course of a disease over time without intervention.

• Nocebo – An adverse effect caused by negative expectations of the patient, the opposite of the placebo effect.

• Non-specific effect of vaccines – Effects of vaccines that are unrelated to their target disease but impact other aspects of immunity.

• Nottingham Health Profile – A health status questionnaire used to assess the impact of disease on quality of life.

• Open flow microperfusion – A minimally invasive technique used for sampling interstitial fluid to study drug distribution.

• Patient diary – A tool used by clinical trial participants to record symptoms, adherence, and other patient-reported outcomes.

• Patient-reported outcome – Any report of the status of a patient's health condition that comes directly from the patient.

• Pearl Index – A statistic used to evaluate the effectiveness of a contraceptive method, measured in pregnancies per 100 women-years.

• Pharmacovigilance – The science and activities related to detecting, assessing, and preventing adverse effects of pharmaceutical products.

• Phases of clinical research – The four stages (Phase I–IV) of clinical trials used to assess safety, efficacy, and post-marketing surveillance of a treatment.

• Placebo – A substance or treatment with no therapeutic effect, used as a control in clinical trials.

• Placebo in history – The historical use and development of placebos in medical research and clinical practice.

• Placebo-controlled study – A clinical trial where the effects of an experimental treatment are compared against a placebo.

• Pocock boundary – A statistical stopping rule used during interim analysis to evaluate early efficacy or safety concerns.

• Pooled analysis – A method of combining data from multiple studies to increase statistical power and robustness.

• Population study – Research that investigates the health outcomes of populations rather than individuals, often used in epidemiology.

• Post hoc analysis – An analysis conducted after a study has been completed, often exploratory and not pre-specified in the protocol.

• Postmarketing surveillance – The monitoring of a drug's performance and safety after it has been approved and released to the market.

• Pragmatic clinical trial – A study designed to evaluate the effectiveness of interventions in real-world clinical settings.

• Principal investigator – The lead researcher responsible for the conduct and oversight of a clinical trial at a site.

• Prioritization – The process of selecting and ranking clinical studies based on importance, feasibility, or potential impact.

• Randomized controlled trial – A trial in which participants are randomly assigned to different treatment groups to reduce bias and establish causality.

• Rapid reviews – Accelerated systematic reviews that provide timely evidence synthesis to inform urgent healthcare decisions.

• Real world data – Data collected from routine clinical practice or non-trial settings, used to assess treatment outcomes in general populations.

• Real world evidence – Clinical evidence derived from analysis of real world data to inform health care decisions.

• Remote data capture – A method of electronically collecting clinical trial data from participants outside of the study site.

• Remote data entry – The process by which investigators enter trial data directly into an electronic system from remote locations.

• Research in Parkinson's disease – A field of clinical research focused on understanding and treating Parkinson's disease.

• Response-rate ratio – A metric comparing the proportion of responses between two groups in a clinical trial.

• Retrospective cohort study – An observational study using past data to assess outcomes in groups based on previous exposure.

• Run-in period – A phase before randomization in a clinical trial used to assess participant compliance and stabilize conditions.

• Safety monitoring – The ongoing review of adverse events and other safety-related data in a clinical trial to protect participants.

• Serious adverse event – An adverse event that results in death, is life-threatening, or causes significant disability or hospitalization.

• Sham surgery – A placebo surgical procedure used to control for placebo effects in trials evaluating surgical interventions.

• Solidarity trial – A multinational WHO-led clinical trial designed to evaluate COVID-19 treatments quickly and efficiently.

• Solomon four-group design – An experimental design used to control for the effects of pretesting on the results of a study.

• Sorby Research Institute – A British research institute known for conducting human nutrition and clinical trials during WWII.

• Source document – The original record containing the data collected during a clinical trial, used to verify accuracy and integrity.

• Standard operating procedure – A set of written instructions that describe routine processes and practices in clinical research.

• Standard treatment – The currently accepted and widely used treatment for a specific condition, often used as a comparator in trials.

• Stepped-wedge trial – A type of randomized controlled trial where all participants receive the intervention in a staggered manner over time.

• Subjective report – A personal account of symptoms or outcomes provided by the trial participant, often used in patient-reported outcomes.

• Treatment and control groups – Groups in a trial where one receives the experimental intervention and the other receives standard care or placebo.

• Vaccine trial – A clinical trial conducted to assess the safety, immunogenicity, and efficacy of a vaccine.

• Validation (drug manufacture) – The documented process of proving that a drug manufacturing process consistently produces a product meeting its quality standards.

• Zelen's design – A randomized clinical trial design where consent is obtained after randomization, used to reduce bias.

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