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HOME>>Research Terminology Tuesday, October 23 2018

Common Research Terminology
Antibodies and Antigens
An antibody is a type of protein that circulates in the body, and it is an important part of the immune system. Antibodies recognize and attach to certain proteins, called antigens, that are part of something harmful (such as bacteria, viruses, or parasites) to the human body. Once attached, antibodies signal the rest of the immune system to come and eliminate the harmful material.
Clinical Research Coordinator (CRC)
The Clinical Research Coordinator is a nurse who closely works with the PI/AIs, clinical trial volunteers, and study sponsors to assist volunteers in navigating through the study visits. They also help with administering treatments, conducting assessments and collecting data for analysis.
Clinical Trial
A research study that involves people, and which tests a new medication, vaccine, treatment or medical device.
Clinical Trial Volunteer
A person who gives their consent and participates in a clinical trial.
Many of our studies compensate subjects for the time and effort of their participation. This may include free health assessments, as well as some form of financial compensation. The amount and type of compensation varies from trial to trial, please go to Join A Study to look at individual studies.
We often think of diseases as being a medical condition with symptoms you can observe in the body. However, disease can simply be thought of as a state of something being abnormal, and this can be physically, mentally, or emotionally.
Food and Drug Administration (FDA)
The United States Food and Drug Administration is an agency within the Department of Health and Human Services. The FDA is responsible for assuring the safety, effectiveness and security of human and veterinarian drugs, vaccines, and other biological products and devices.
Immunity means your body has either a natural or acquired ability to protect itself against getting a disease when you are exposed to it. Immunity against a disease can be given to a person by getting a vaccine, or by getting the actual illness/disease and your body naturally building immunity to it.
Inclusion/Exclusion Criteria
Most studies will have a list of characteristics that a person needs to have in order to participate. These are called inclusion criteria. Inclusion criteria are different for every study. Inclusion criteria can involve such things as a person’s age, gender, travel and medical history. As an example, one study might have inclusion criteria that only persons between the ages of 18 and 30, who received the chickenpox (varicella) vaccine as a child, can participate. Therefore, a 22 year-old person who was vaccinated against chickenpox as a child would meet the inclusion criteria and could participate in the study. A 35 year-old person who had chickenpox as a child, and so was never vaccinated, would not meet the inclusion criteria, and could not participate.

Most studies will also usually have a list of characteristics that person cannot have in order to participate. These are called exclusion criteria. Exclusion criteria are also different for every study, and can involve the same types of things as the inclusion criteria do (see above). As an example, a study testing an influenza ("flu") vaccine might have the exclusion criteria that persons who have already had the "flu" that year cannot participate.
Informed consent
Every clinical trial will have an informed consent document. This is a written document that explains the events that will occur in a clinical trial, along with all the potential risks and benefits from participation. When a volunteer wants to be part of a study they will be asked to review and sign an informed consent document stating they understand what the study is about and would like to participate. This is not a contract; a volunteer is free to leave a study at any point if they decide they want to.
Institutional Review Board (IRB)
An Institutional Review Board (IRB), also known as an Independent Ethics committee (IEC) or an Ethical Review Board (ERB) is a group of individuals whose job it is to review potential studies and ensure that they are safe and ethical for people to participate in. IRBs consist of people with diverse expertise and backgrounds to ensure that a wide range of viewpoints are available in the review of any study. The U.S. Food and Drug Administration and the Department of Health and Human Services give IRBs the authority to review research protocols and approve, disapprove or require modifications to them.
Phases of Clinical Trials
You may often hear a study being called a Phase I or a Phase II Clinical Trial. There are several different phases of Clinical Trials and a new drug, vaccine or device must advance through each phase successfully in order to be approved by the FDA for general use. On average it takes around 12 years of rigorous research to get a drug approved.
  • Phase I: In a Phase I Clinical Trial a small group of healthy volunteers is recruited to test how safe and well-tolerated an investigational drug or vaccine is. This is generally the first time this drug or vaccine has been used in humans, and a low dose will be used at first, and the volunteers will be monitored closely for side effects.
  • Phase II: In a Phase II Clinical Trial, a larger group of healthy volunteers is recruited to again test safety, but also now to evaluate how effective this drug or vaccine is at preventing, protecting or treating the volunteer from a certain illness or disease.
  • Phase III: In a Phase III Clinical Trial, Medical Scientists and Physicians must now show that the drug or vaccine that demonstrated safety, tolerability and effectiveness in a Phase I and Phase II clinical trial continues to work as well in a larger population.
For a particular drug or vaccine, more than one study may be performed at each phase, or in some cases, multiple phases may be combined in a single study. After all necessary studies are complete the data will be evaluated and presented to the FDA, who may grant approval for its use.
The word Phlebotomy comes from the Latin language and it means ‘to cut a vein’. It is the formal term for collecting (or 'drawing') blood from a person. The lab workers who perform these blood draws are called Phlebotomists and they have specialized training in drawing blood safely.
A placebo is something that looks just like a vaccine or medicine, but does not have any actual medicine in it. In some of our clinical trials, a portion of the subjects are given a placebo, while the rest are given the actual drug or vaccine being tested, in order to better evaluate the true effects of the vaccine. Common placebos include types of salt water, called “saline”, and sugar pills.
Placebo-Controlled Study
A placebo-controlled study is a type of clinical trial study design. In this clinical trial, the volunteers will be separated into two groups. One group will receive the treatment and the other group will be given a placebo. A placebo is something that looks exactly like the vaccine or drug but does not have any actual medicine in it. Common placebos include types of salt water, called “saline”, and sugar pills.
Principal Investigator (PI) and Associate Investigators (AI)
The Principal Investigator (PI) is the main doctor leading the study and research team. Associate Investigators (AI) assist the PI in seeing clinical trials volunteers, giving treatments, monitoring them closely and documenting all findings.
Every study has a protocol. This is a written plan that details how the study will be conducted. This protocol is reviewed by at least one Institutional Review Board (IRB), and often times several IRBs to ensure that it is safe and ethical for volunteers to participate in.
Randomization is a term you may hear in a study brief, or see in an informed consent document. If the clinical trial wants to compare two things, like people who receive a treatment compared to people who do not receive a treatment, a randomization process occurs. This means that all the volunteers will be randomly put in one group or the other. It can be thought of like flipping a coin, but the process is normally computerized and often the study personnel will not know who is in what group. This is so that there is no personal preference for who goes to a certain group.
A vaccine is a drug designed to get your body to build a temporary or life-long protection (called immunity) against a particular disease or group of diseases. Vaccines are made up of many different chemicals and components, depending on the disease they are to help prevent, and may include killed or weakened parts of the bacteria, virus or parasite they are designed to protect against. Vaccines can come in many forms, pills, liquids that you drink or inhale, but are most commonly given as injections.

Last Modified Date: 16-March-2017

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