for participants and caregivers

What is a clinical research study?

A clinical study is medical research that determines the safety and effectiveness of a drug or treatment and discovers any side effects. Clinical studies use humans; pre-clinical studies use animals. Clinical trial patients are able to participate in various kinds of studies.

the drug or treatment under study may be:

• new and not tested on people before
• an existing one being used in a new way

In some clinical studies, a new drug or treatment may be compared with the best-known standard therapy to see whether it is more effective or causes fewer side effects. Clinical trial patients enable researchers to determine the best use for these drugs and therapies.

information from clinical studies:

• helps regulatory authorities around the world decide whether to approve a drug for use in their country
• guides health professionals in their decisions about prescribing drugs or other treatments to patients
• assists consumers with the proper use of over-the-counter and prescription medications

(source: ClinicalResearch.com by Quintiles)

A clinical investigator is a medical researcher, typically a doctor, who’s chief responsibility is to administer a research study. Each research study has a specific protocol or plan that is designed to understand certain effects of the given study medication or treatment.

• Phase I trials determine the basic safety of a drug or treatment and the affects it may have on the body. Lasting anywhere from a few days to a few months, these studies are preformed on small groups of people (10 – 100). Phase I studies also help to determine safe dosages and identify side effects.
• Phase II trials are conducted on larger groups of people (100 – 200) and look at the drug or treatments effectiveness and dosing for people who suffer from a specific disease or condition.
• Phase III trials are conducted on very large groups of individuals (300 – 3,000) and are designed to determine effectiveness, monitor side effects relative to existing drugs used to treat the same disease and to collect information that will allow the drug or treatment to be used safely.
• Phase IV trials begin after a drug has been available on the public market. These studies help investigators prove the safety of a specific drug or treatment in a more diverse group of volunteers and the effectiveness of dosage, formulations and new uses that may not have been considered previously.

why participate in a clinical study?

Individuals volunteer to participate in a clinical trial for a number of reasons and may include:

• You can expect high quality study-related medical care at no cost to you while assisting in the advancement of medical science.
• In many cases, you may be getting medications or treatment that will not be available to the general public for a number of years.
• You may be benefitting someone you know in the future.
• You may be able to do all these things and be compensated for your time and travel.