Clinical trials can be overwhelming. How do you know if you are eligible or not? A Clinical Trial is defined as an investigation or a study to see whether a treatment is safe for human use and if it is effective in curing a disease. Other important terms you'll encounter include the following:
1. Adverse Event:
This is most commonly known as a side effect. It is when a study participant has a negative experience that is associated with the treatment.
2. Blinding or Masking:
When one or more parties involved in the trial are not aware of the treatment assignments. There can be many different types of blinding; Single Blinding means that the study participants don’t know what group they have been assigned to, Double Blinding means that both the study participants and the investigators don’t know who has been assigned to each treatment group.
3. Clinical Research Coordinator:
The medical professional who is responsible for the clinical trial at each specific site. For example, if the trial is being conducted at 8 different hospitals, each hospital will have it’s own Clinical Research Coordinator, but only 1 Principal Investigator.
The opposite of the treatment. For example, you may have a control group in your study that is not receiving the treatment being studied. This could mean they are receiving the standard of care (in phase 3 studies) or receiving a placebo (in phase 1 and 2 studies).
5. Eligibility Criteria:
The criteria or restrictions on who can participate in the Clinical Trial. This is different for every trial and can sometimes be referred to as the Inclusion and Exclusion Criteria.
The number of people that must be signed up for the trial in order for the trial to be considered complete.
7. Informed Consent:
A document that describes what each participant will be experiencing during the clinical trial. It will also include possible side effects and benefits of the trial and the rights of each participant completing the trial. Each study participant must sign this document before they enroll in the trial.
The treatment or drug that is being studied in the Clinical Trial. This term is typically used when compared to a control.
A medical professional who is directing the administration of the treatment to participants and who is studying the treatment’s safety/efficacy.
The categories that each Clinical Trial can fall into based on what properties of the treatment are being studied in the trial and how many participants are involved.
A substance that does not hold any of the active ingredients of the treatment. It may look and taste like the active treatment, but it will not cause any changes within the human body. This can sometimes be referred to as a “sugar pill.”
The written description of the Clinical Trial. Protocols typically include how the trial will be conducted, what are the goals for the trial, and who can participate.
13. Principal Investigator:
Sometimes called a “P.I.” and is the lead medical professional, typically a doctor, who is conducting the clinical trial.
The process in which study participants are randomly assigned to different treatment groups. This is to insure that everybody has an equal chance of being a part of each treatment or control group.
The organization that is responsible for the clinical trial and determining if the treatment is effective. This could be a university, a pharmaceutical company, or a research hospital.
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Post courtesy of CANTRIA.