Clinical Trials Glossary of Terms
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In medicine, the act of giving a treatment, such as a drug, to a patient. It can also refer to the way it is given, the dose, or how often it is given.
An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied.
A group or subgroup of participants in a clinical trial that receives specific interventions, or no intervention, according to the study protocol. This is decided before the trial begins.
A gene on chromosome 17 that normally helps to suppress cell growth. A person who inherits certain mutations (changes) in a BRCA1 gene has a higher risk of getting breast, ovarian, prostate, and other types of cancer.
A gene on chromosome 13 that normally helps to suppress cell growth. A person who inherits certain mutations (changes) in a BRCA2 gene has a higher risk of getting breast, ovarian, prostate, and other types of cancer.
A type of clinical trial in which observations made during the trial are compared to a standard, called the control. The control may be observations of a group of participants in the same trial or observations from outside the trial (for example, from an earlier trial, which is called a historical control).
Describes a clinical trial in which groups of participants receive two or more interventions in a particular order. For example, a two-by-two cross-over design involves two groups of participants. One group receives drug A during the initial phase of the trial, followed by drug B during a later phase. The other group receives drug B during the initial phase, followed by drug A. So during the trial, participants “cross over” to the other drug. All participants receive drug A and drug B at some point during the trial but in a different order, depending on the group to which they are assigned.
Data Monitoring Committee (DMC)
A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The group can recommend to the study sponsor that the study be stopped if it is not effective, is harming participants, or is unlikely to serve its scientific purpose. Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also referred to as a data safety and monitoring board (DSMB).
A clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo or another therapy. Double-blind trials are thought to produce objective results, since the knowledge, expectations and biases of the doctor and the participant about the experimental drug or treatment do not affect the outcome.
The ability of a drug or treatment to produce a beneficial result. A drug demonstrates efficacy if it is effective at the dose tested against the illness for which it is prescribed.
The key standards that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria include both inclusion criteria and exclusion criteria. For example, a study might only accept participants who are above or below certain ages.
The number of participants in a clinical study.
Exclusion and inclusion criteria
The medical or social standards determining whether a person may or may not be allowed to enter a clinical trial. These criteria are based on such factors as age, gender, pregnancy status, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate participants to ensure the integrity of the study and to keep them safe.
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
HIPAA established national standards for electronic health care transactions and national identifiers for providers, health plans, and employers. It also addresses the security and privacy of health data. All clinical trial data and activities performed by covered entities must comply with HIPAA regulations.
The study of the complete set of DNA (including all of its genes) in a person or other organism. Almost every cell in a person’s body contains a complete copy of the genome. The genome contains all the information needed for a person to develop and grow. Studying the genome may help researchers understand how genes interact with each other and with the environment and how certain diseases, such as cancer, diabetes, and heart disease, form. This may lead to new ways to diagnose, treat, and prevent disease.
In cancer, a description of a tumor based on how abnormal the cancer cells and tissue look under a microscope and how quickly the cancer cells are likely to grow and spread. Low-grade cancer cells look more like normal cells and tend to grow and spread more slowly than high-grade cancer cells. Grading systems are different for each type of cancer. They are used to help plan treatment and determine prognosis. Also called histologic grade and tumor grade.
The study of tissues and cells under a microscope.
The prevention or treatment of disease with substances that stimulate the immune response.
A process used by researchers to communicate with potential and enrolled participants about a clinical study. As part of the informed consent process, researchers:
- Provide all the important information about the study, so potential participants can decide whether to enroll or, if they are already enrolled, whether to continue to participate;
- Make sure that potential participants understand the risks and potential benefits of participating in the study and the alternatives to the research being conducted; and
- Stress that enrolling in, and staying in, a clinical study is completely voluntary. Because giving consent to participate in research is not a contract, participants may leave a study at any time.
The goal of the informed consent process is to protect participants. It begins when a potential participant first asks for information about a study and continues throughout the study until the study ends. The researcher and potential participant have discussions that include answering the participant’s questions about the research. All the important information about the study must also be given to the potential participant in a written document that is clear and easy to understand. The informed consent document is reviewed and approved by the human subjects review board before the document is given to potential participants. Generally, a person must sign an informed consent document to enroll in a clinical study.