Participating in Clinical Trials

Terms to Know

Terms Used in Clinical Trials

Protocol

A protocol is the detailed study plan that will be followed to answer specific research questions. It describes

Eligibility (Inclusion or Exclusion) Criteria

Eligibility (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

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

Side Effects

Side effects are unwanted or unexpected negative effects, such as a headache or skin irritation, caused by taking a drug or treatment. Side effects can be serious and even life threatening.

Experimental Group and Control Group

The experimental group gets the experimental product 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 product.

Randomized Controlled Trial (RCT)

A randomized controlled trial (RCT) is a study in which participants are randomly (that is, by chance) assigned to either the control group or the experimental group. Neither the researchers nor the participants can choose the group in which they are placed.

Double-blind Study

In a "double-blind" study, the researchers and participants won't know who has been placed into the experimental group until the study is over.

For more clinical trial terms, go to the ClinicalTrials.gov Glossary at http://clinicaltrials.gov/ct/info/glossary.