Glossary of Clinical Trial Terminology
Clinical trial research is a complex and varied area of science. Clinical trials are conducted to ensure drug (pharmaceutical) and device safety. The following are some common terms you might see during your participation in a clinical trial.
Approved Drugs - drugs that have undergone and passed the vigorous US Food and Drug Administration (FDA) testing and approval process.
Baseline - the time during a clinical trial before a participant receives the drug or treatment being studied. Baseline measurements are then compared to measurements taken after the participant begins using the drug or treatment.
Blind - a clinical trial is called "blind" when participants are not told if they are receiving the actual treatment or a placebo.
Clinical Investigator - the researcher in charge of the clinical trial.
Clinical Trial - a type of research study that uses human volunteers to see if certain medications or treatments are safe and effective.
Confidentiality - in regards to clinical trials, this means that the personal identities and medical information of study participants remain anonymous, and may be identified by a number not associated with their name.
Contraindication - a circumstance in which the use of a drug or treatment should not be used.
Control Group - the group of study participants who receive a placebo instead of the drug or treatment being studied.
Diagnostic Trials - a type of clinical trial that looks for better way to diagnose a disease or condition.
Double-blind Study - a type of study in which neither the participants nor the research staff knows who receives the drug and who receives the placebo.
Efficacy - the ability of a drug or treatment to produce positive results.
Experimental Drug - drugs that have not received FDA approval for a particular condition. If a drug is used to treat conditions other than what it was approved for, this is called "Off-label use."
FDA (Food and Drug Administration) - an agency of the U.S. Department of Health and Human Services responsible for making sure that all drugs, vaccines, and medical devices are safe and effective.
Inclusion/Exclusion Criteria - the guidelines or standards that determine whether or not a person qualifies to participate in a clinical trial.
Informed Consent - the process by which research staff explain the details of a clinical study to participants of a clinical trial.
Institutional Review Board (IRB) - a group of doctors, researchers, community advocates, and others who ensure the ethical nature of a clinical trial and make sure that the rights of the study participants are protected.
Open-label Trial - a clinical trail in which both the research staff and the study participants know which drug or treatment is being studied.
Phase I Trials - the first step of a clinical trial in which a drug or treatment is tested on a small group of people to assess dosage, study how the drug works in the body, and see if it has any side effects.
Phase II Trials - the second step of a clinical trial in which the drug is tested on a larger group of people to see if it is effective and to further test its overall safety.
Phase III Trials - the third step of a clinical trial in which researchers look even more closely at the drug's effectiveness, if it has any side effects, its overall safety, and how it can improve a person's quality of life.
Phase IV Trials - the final step of a clinical trial that occurs after FDA approval. This phase involves monitoring the drug after it has been released to the public to see if there is any new information such as risks, benefits, or additional uses of the drug.
Placebo - a substance with no active ingredients and no treatment value. Used to compare with experimental drugs or treatments.
Prevention Trials - a type of clinical trial that looks for better ways to keep people healthy or keep a disease from returning.
Protocol - the plan on which the entire clinical trial is based. The protocol describes exactly what the participants must do during the trial such as how often they need to see the research staff, how much of the drug they need to take, what other procedures they must follow, and how long the trial will last.
Quality of Life Trials - a type of clinical trial that looks for better ways to improve the quality of life of people with chronic illnesses.
Randomized Trials - a study design in which participants are randomly assigned to one of the two or more groups being used to study the drug or treatment.
Screening Trials - a type of clinical trial that looks for better ways to detect a disease.
Side Effects - any undesired results of a drug or treatment.
Treatment Trials - a type of clinical trial that tests new drugs or treatments.