Below is a glossary of clinical trial terms that are meant to help you to better understand the language of clinical trials.
Adverse Event (AE) [Show Definition]
Any untoward or unfavorable medical occurrence in a clinical research study participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease. A serious adverse event is any adverse event that results in death, is life-threatening, requires or prolongs hospitalization, causes disability or incapacity, results in birth defects, or is any other hazardous condition. An adverse reaction refers to an effect that is caused by the study drug.
Blinded Study [Show Definition]
A clinical trial is called a blinded study if the participant is not told which arm of the trial he or she is on. Double-blind trials are designed so that neither the participant nor the study team knows whether the participant is receiving the experimental drug or the placebo.
Clinical Trial [Show Definition]
A clinical trial is a research study in human volunteers that Definitions specific health questions. Clinical trials can be interventional (involving a study drug or treatment) or observational (recording data with no intervention) research studies. Clinical trials usually progress through four phases: Phase I, Phase II, Phase III, and Phase IV to determine if a new drug or treatment is safe and effective. Carefully conducted clinical trials are the safest and fastest way to discover treatments that work in people to improve their health.
Confidentiality [Show Definition]
Refers to making sure that only those involved in the study have access to the participant’s personal identity and all personal medical information. The participant’s consent to the use of records should be obtained prior to the trial and assurance must be given that confidentiality will be maintained.
Control Group [Show Definition]
Given either a standard treatment for the condition or a placebo. Since this group will not be given the experimental treatment, it will be used as a comparison against those in the experimental group.
Eligibility Criteria [Show Definition]
Specific criteria that a participant must meet in order to take part in a clinical trial. These criteria could include age, gender, type of disease, previous treatment history, and other medical conditions.
Food and Drug Administration (FDA) [Show Definition]
An agency of the U.S. Department of Health and Human Services responsible for protecting and promoting public health by ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices. The FDA also regulates and supervises other industries such as blood banks, food, veterinary products and cosmetics.
Good Clinical Practice (GCP) [Show Definition]
A standard for clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of research participants are protected.
Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule [Show Definition]
The first Federal regulation that establishes the private use of personal health information for research purposes. The Privacy Rule is a set of national standards for the protection of individually identifiable health information known as protected health information (PHI).
Informed Consent [Show Definition]
The process of learning facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. The study team will explain the details of the study before the participant decides to take part in the clinical trial.
Institutional Review Board (IRB) [Show Definition]
A committee of members of varying backgrounds, including representatives from the medical staff, chaplaincy services, nursing, pharmacy, administration, and the community, that ensures a clinical trial is ethical and protects the rights of study participants. The IRB initially approves and periodically reviews the research.
Phase I Trials [Show Definition]
Initial studies test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dose range, and identify side effects.
Phase II Trials [Show Definition]
The experimental study drug or treatment is given to a larger group of people (100-300) to not only see if it is effective but also to further evaluate its safety.
Phase III Trials [Show Definition]
The experimental study drug or treatment is given to large groups of people (1000-3000) in order to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
Phase IV Trials [Show Definition]
Post-marketing studies provide additional information such as the drug or treatment risks, benefits and optimal use.
Placebo [Show Definition]
A placebo is an inactive pill, liquid, or powder that has no treatment value. In some studies, the participants in the control group will receive a placebo instead of the experimental drug or treatment. A sick participant will not receive a placebo if there is a known beneficial treatment.
Principal Investigator (Study Doctor) [Show Definition]
A medical researcher who is responsible for carrying out a clinical trial's protocol. The study doctor should not be used as the participant’s primary care doctor.
Protocol [Show Definition]
A detailed study plan that is carefully designed to safeguard the health of the participants as well as Definition specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study.
Randomization [Show Definition]
A method based on chance which assigns study participants to a treatment group. Randomization reduces the differences among groups by equally dividing the participants with different characteristics among all the trial arms. It is unknown which treatment is better.
Standard of Care Treatment [Show Definition]
A treatment that is currently being used and is already approved by the FDA. It is considered to be effective in the treatment of a specific disease or condition.
Study Coordinator/Research Nurse [Show Definition]
Study Coordinators are members of the study team who are responsible for such things as enrolling study participants and following them through the course of the trial, as well as ensuring the adherence to Good Clinical Practice guidelines.
Study Participant [Show Definition]
A volunteer who participates in a clinical trial, either as a recipient of the experimental drug or treatment, or as a control who receives the standard of care treatment, or as a healthy volunteer who receives no treatment. 
