Participating in Clinical Trials
Terms to Know
Terms Used in Clinical Trials
- protocol
- inclusion and exclusion criteria
- placebo
- standard treatment
- side effects
- treatment group and control group
- randomized clinical trial
- double-blind study
Protocol
A protocol is the detailed study plan that will be followed to answer specific research questions and protect the trial participants. It describes
- what type of people are needed in the trial
- the schedule of tests, procedures, drugs, and dosages
- how long the study will last
- how to measure the beneficial and harmful effects.
Inclusion or Exclusion Criteria
Inclusion or exclusion criteria are the set of social and medical characteristics researchers use to decide who can take part in a clinical trial. These may include
- a person's age and gender
- the type and stage of their disease
- previous treatment history
- any other medical conditions.
Placebo
A placebo, sometimes called a sugar pill, is a substance that looks like the experimental drug but has no active ingredients. Researchers compare the effects of experimental treatments with placebos.
Standard Treatment
Standard treatment is a therapy that is
- effective for a specific disease or condition
- currently in wide use
- usually approved by the U.S. Food and Drug Administration
- used to compare with the newer treatment, to see which is better.
Side Effects
Side effects are unwanted or unexpected negative effects, such as a headache or skin irritation, caused by taking a drug or treatment. Adverse reactions are more serious side effects that can even be life threatening.
Treatment Group and Control Group
The treatment group gets the experimental treatment and the control group gets the standard treatment, a placebo, or no treatment at all. The results from the two groups are compared to determine the effectiveness of the experimental treatment.
Randomized Clinical Trial (RC)
A randomized clinical trial (RCT) is a study in which participants are randomly (that is, by chance) assigned to either the control group or the treatment group. Neither the researchers nor the participants can choose the group in which they are placed.
In a "double-blind" study, the researchers and participants won't know who has been placed into the treatment group until the study is over.
Double-blind Study
For more clinical trial terms go to ClinicalTrials.gov Glossary at http://clinicaltrials.gov/ct/info/glossary.
