How to use this booklet

For many people the idea of being involved in research raises fears of ‘experimentation’ or of being a ‘guinea-pig’. Understanding what is involved in taking part in a research study can ease many of these anxieties. This booklet answers the questions patients ask most often about clinical trials, and can help you decide about taking part in a trial. It is meant to add to the information your doctor has already given you.

The ‘Glossary’ defines some of the common technical words used in clinical trials.

What is a clinical trial?

Almost every week we hear of a new drug for the treatment of a disease, or of a new diagnostic test or surgical procedure. These new treatments, tests and procedures must be shown to be effective and safe before they can be marketed or used more widely. A clinical trial is a research study in patients to test the usefulness and safety of a promising new treatment or procedure.

Clinical trials are used to study new ways to prevent, diagnose or treat diseases. Most trials evaluate new drugs or drug combinations, for example, antibiotic treatments for an infectious disease, or chemotherapy for a specific cancer. Other trials might test new radiation treatments or surgical procedures, such as a comparison of radical mastectomy vs. lumpectomy for the treatment of breast cancer. The example of a drug trial will be used throughout the rest of the booklet.

Clinical trials begin only after preliminary studies in the laboratory and with animals have shown promising results.