The glossary below will assist you in understanding the words and phrases that frequently appear on ClinicalResearch.com. Although people involved in clinical research will often use these words and phrases, the definitions here describe the words and phrases only in the context of how they appear on ClinicalResearch.com.
Unwanted effect of a drug, device, or procedure. Sometimes an adverse event may be due to something other than the drug, device, or procedure.
Organizations that assist specific patient populations and their families, and provide them with useful support tools.
In each region/country, the local authority must review and approve a new medication so that it can be sold/prescribed. For example, the Food and Drug Administration completes this review in the United States, and the European Medicines Agency completes this review in Europe.
A group of participants in a clinical trial in which everyone in the group is receiving the same treatment at the same dose. Clinical trials comparing different treatments (comparative clinical trials) have at least 2 arms.
The point at the start of a clinical trial right before a participant receives an investigational treatment. Data collected at baseline is compared with data gathered later in the trial. The differences measured can help to determine the safety and efficacy of an investigational treatment.
Any medical product manufactured from a living organism or its products.
A clinical trial is blinded if the participants and/or investigators do not know which arm the participants are assigned to.
The scientific activities that take an investigational drug, device, or procedure from Phase 1 through to Phase 4.
The study of health and illness in people. Clinical research is how we develop new treatments and gather knowledge for better health and medical care.
Performs all the necessary checks to help ensure the rights and safety of participants are guaranteed and the trial follows the protocol closely. Click here to see the people you might meet as a clinical trial participant.
Involved in monitoring trial-related activities and making sure they are done properly. Click here to see the people you might meet as a clinical trial participant.
A research study involving human participants that tests and evaluates an investigational drug, device, or procedure to find out how safe it is and how well it works.
A clinical trial’s blueprint, describing in detail the steps of the trial.
A group of participants recognized as having at least one shared characteristic.
The drug, device, or procedure (approved or investigational), or placebo, that the investigational drug, device, or procedure is compared with in a clinical trial.
Complying with all trial-related requirements, including adhering to the Good Clinical Practice guidelines and ethical and legal obligations.
An organization (commercial, academic, or other) that the sponsor hires to take over one or more of the tasks and responsibilities related to the running of a clinical trial.
One or more arms of participants will receive the investigational drug, device, or procedure, and the control arm will receive either the current standard drug, device, or procedure for the condition being investigated, or a placebo. The control arm will be compared with the investigational arm(s) in a clinical trial to see if the investigational drug, device, or procedure is effective.
Works with the trial team to collect and organize all relevant clinical research data according to the protocol. Click here to see the people you might meet as a clinical trial participant.
A series of ethical principles concerning medical research involving human beings, first published by the World Medical Association in 1964 in Helsinki, Finland. These principles include processes that need to be followed to make sure patients are safe taking part in clinical trials.
Clinical trial participants’ individual characteristics, such as sex, age, medical history, relatives’ medical history, and traits, that are applicable to the clinical trial.
Refers to how much medicine is given in one dose, how often a dose of medicine is given per day, and the time that passes between each dose.
In double-blind clinical trials, neither the trial doctor nor the participant knows which treatment arm the participant is assigned to.
The effectiveness of the drug, device, or procedure being investigated.
The inclusion and exclusion criteria, which investigators use to select participants for the trial.
An outcome that the trial is intended to assess.
The overall process by which a potential participant joins a clinical trial.
An ethics committee is a body of medical and non-medical specialists who are responsible for confirming the safety, integrity, and human rights of the trial participants.
Regulatory agency responsible for issuing rules and regulations in Europe regarding the conduct of clinical trials. The European Medicines Agency is also responsible for reviewing and approving new medicines in Europe so that they can be sold/prescribed.
Part of the eligibility criteria. The exclusion criteria are used to determine if a person should be excluded from taking part in a clinical trial. The exclusion criteria vary by trial.
The US Food and Drug Administration processes that supply investigational medications to participants who are not able to take part in clinical trials and are not responding well to available medications.
The federal agency of the US Department of Health and Human Services that enforces the Food, Drug and Cosmetics Act. The Food, Drug and Cosmetics Act is a collection of laws approved by the US federal government, which gives authority to the Food and Drug Administration (FDA) to supervise the safety of food, drugs, and cosmetics in the United States. In the context of clinical research, the FDA is responsible for reviewing and approving new medicines in the United States so that they can be sold/prescribed.
An approved drug with the same active ingredient and intended use as a brand-name drug, but not the same inactive characteristics, such as color and taste. Only after the brand-name drug’s patent has expired can a generic drug be marketed.
An international set of ethical and scientific quality standards that all aspects of clinical research must meet.
Testing that takes place outside the body in an artificial setting, such as a test tube.
Testing that takes place in humans and animals.
The number of new occurrences of a disease in a group of people during a specific period of time.
Part of the eligibility criteria. The inclusion criteria are used to determine if a person may be able to participate in a clinical trial. The inclusion criteria vary by trial.
For people who are under the age of consent in their country, their parents/legal guardian will need to sign an Informed Assent Form to enable their child to take part in the trial.
Clinical trial regulation requires researchers to give potential participants complete written information about the clinical trial before they agree to participate. This is called informed consent. The information provided must be written in a manner that allows the potential participant to understand all the trial details.
Before joining a clinical trial, participants need to sign the Informed Consent Form (ICF) to show they have been given information about the clinical trial and that they agree to take part in it. Even after they sign the ICF, participants can leave the clinical trial at any time and for any reason without penalty.
A group of people who review elements of a clinical trial, such as the protocol and patient recruitment materials, to make sure that the trial is safe and has the potential to be effective for participants. The institutional review board also checks that all the US Food and Drug Administration’s rules and regulations are followed.
A project to unite regulatory authorities and pharmaceutical companies, so together they can make the scientific and technical aspects of developing and registering new medicinal products more efficient.
A process at the core of a clinical trial. This can include any product, investigational or approved, given to participants in a clinical trial, and non-invasive tactics, such as changes to diet and exercise.
A clinical trial that aims to test a potential new drug, medical device, or surgical procedure (referred to as the “intervention”).
A potential new drug that is undergoing clinical research.
An observational study in which data are measured two or more times from the same population of patients over a period of time.
A member of the trial team who is appointed by the sponsor to perform all the necessary checks to make sure the trial follows the protocol closely and the rights and safety of participants are assured.
An agency of the US Department of Health and Human Services that focuses on funding health and medical research.
All data (non-clinical, clinical, pharmacological, and pharmacokinetic) related to a drug that are compiled and presented to the US Food and Drug Administration so the drug can be approved for marketing in the United States.
A type of clinical research study that aims to learn more about approved medications through observation. For people who take part, the treatment and medical care they receive is what they are currently receiving, i.e. they are not prescribed anything by and do not receive medical care from the people involved in the study.
When a drug approved by the US Food and Drug Administration is used for a condition it has not been approved for.
A clinical trial is open-label if the participants and doctors know which treatment arm patients are assigned to.
In a clinical trial, the safety and efficacy of an investigational drug, device, or procedure are measured by outcomes. These outcomes are related to patients, such as patient survival or health-related quality of life.
Refers to a medicine that is available for purchase in a pharmacy without a prescription.
This document has ethical approval and contains details about the trial rationale and aim, the intervention being tested, potential risks and benefits, and trial-related procedures. The Participant Information Sheet covers the information that needs to be explained and discussed with potential participants and their legal representatives or parents, if applicable, before signing the Informed Consent Form.
The study of the relationship between the amount of a drug used and its effects on the body.
The review of the relationship of cost versus benefit for a given drug, device, or procedure compared with other similar treatment options.
The examination of the way the human body takes in, circulates, and excretes a drug.
A placebo is a “dummy treatment,” which looks like the genuine medicine but contains no active ingredient.
Prescreening of potential participants over the telephone, on a clinical trial website, or in person to work out their potential eligibility and suitability for a clinical trial is often a first step for recruiting people into clinical trials.
A clinical trial that aims to discover improved methods to prevent participants who have never had a particular disease from developing it, or to stop a disease coming back.
Responsible for running the clinical trial according to the protocol, keeping accurate records of how the trial procedures are carried out, and reporting any side effects of the trial medication. Click here to see the people you might meet as a clinical trial participant.
Processes that make sure a clinical trial is being managed as per the Good Clinical Practice (GCP) guidelines and that all data produced are correct.
Randomization in a clinical trial is when participants are randomly put into groups and each group is assigned by chance to receive a different treatment.
The period of a clinical trial when the trial team is identifying and enrolling participants.
Each pharmaceutical company has a Regulatory Affairs division. This division is involved in the whole drug development process, and part of its role is being responsible for making sure that each clinical trial complies with government regulations.
Government agencies that are responsible for issuing rules and regulations regarding the conduct of clinical trials in their respective countries (e.g. the US Food and Drug Administration, the European Medicines Agency).
Makes sure the trial is compliant with regulations and ethical standards. Click here to see the people you might meet as a clinical trial participant.
Involved in the screening of potential participants, participant consent, participant randomization, data collection, reporting of adverse events, and preparing trial documents and reports. Click here to see the people you might meet as a clinical trial participant.
Provides trial medication at certain visits and documents the return of trial medication. Click here to see the people you might meet as a clinical trial participant.
The clinical research team are the people involved in running the trial. A clinical research team may include the following people: Principal Investigator, Sub-Investigator, Clinical Research Coordinator, Clinical Research Associate, Regulatory Coordinator, Data Coordinator, Research Nurse, Research Pharmacist, and Trial Assistant. Click here to see the people you might meet as a clinical trial participant.
Any unwanted effect of a drug, device, or procedure that is deadly, is life-threatening, causes permanent disability, or leads to hospitalization.
In single-blind clinical trials, the investigator knows which treatment the participant is receiving, but the participant does not know. Occasionally, it is the other way around and the participant knows which treatment they are receiving, but the investigator does not.
Company or organization starting, managing, and funding a clinical trial.
Official instructions for the organization of clinical trials to make sure that all elements of a clinical trial are carried out in a well-organized and consistent way.
A treatment approach that most healthcare professionals recognize as suitable.
The final date in a clinical trial when data are collected from participants.
Medical doctors that work in a trial under the supervision of the Principal Investigator. Click here to see the people you might meet as a clinical trial participant.
Participant in a clinical trial.
Provides support to the Principal Investigator for trial monitoring and reporting, data management, and audits. Click here to see the people you might meet as a clinical trial participant.
A person’s psychological and physical welfare.