Introduction to Clinical Trials for Consumers

What Is A Clinical Trial?

There are more than 100 different types of arthritis, including rheumatoid arthritis, osteoarthritis, lupus, fibromyalgia and gout. Before medications are approved for use in these conditions, they must undergo strict testing to ensure they are safe and effective. This process of testing a drug in people is called a clinical trial.

A clinical trial is a scientific study that tests the safety and effectiveness of a medical treatment in a person with a specific condition. For example, we may study the safety and effectiveness of a new drug in the treatment of rheumatoid arthritis.

At the Arthritis Research Centre of Canada, we are involved in clinical trials for two main reasons:

To find effective and safe treatments for people with arthritis and related conditions.

People with arthritis may benefit from these clinical trials – particularly when they have not responded to conventional therapy.

Every clinical trial attempts to answer one or more specific research questions that are set out before the trial begins. The study protocol is set up around these questions. The subject of a clinical trial must meet certain eligibility requirements. These may include the disease severity, age, and, for safety reasons, absence of other specific medical conditions.

Before Starting

Before enrolling in any clinical trial, you will be provided with an informed consent document (ICD). The ICD contains information about the purpose of the trial, the possible risks and benefits of the treatment, and all of the procedures involved in the research trial. It will also inform you if there is a placebo (sugar pill) arm of the study. The ICD must be understood, signed and witnessed before you participate in the trial. It is important that any questions or concerns you may have about the research are addressed to your satisfaction BEFORE you sign the ICD.

Risks/Benefits

Research trials have risks and benefits. It is possible that the treatment being tested will improve your health or the quality of your life, or you may decide to participate in a clinical trial for the personal satisfaction that comes from being a part of scientific research.

Medical treatments studied in clinical trials may cause side effects that can vary from person to person. Anticipated side-effects, which are specific to each research trial, are detailed in the ICD.

Your Responsibility

Your first responsibility is to fully understand your commitment to the research trial. Participating in a research trial can be time consuming and you should fully understand what is expected before you begin. The study physicians need you to attend all your appointments, follow instructions carefully and take the study medication exactly as directed.

Your full cooperation and participation are critical, as the information the study physicians collect is vital to the outcome of the medical treatment being testing.

YOU DECIDE

Deciding to participate in a clinical trial is YOUR decision. Even after signing the consent form, you don’t have to continue the trial if you feel uncomfortable about it. You have the right to leave the study at any time.

COMMITMENT

Participating in a clinical trial is much like a regular doctor’s office visit, but usually entails extra time commitments and/or extra testing from a research volunteer. The success of any research study depends on the volunteers.

Before participating in a clinical trial, you should ask the following questions:

What is the main purpose of the study?
How will the study affect my daily life?
Can I continue to take my usual medications?
How many visits are required?
How long will the visits last?
What medication is being tested and is there a chance I will receive a placebo (inactive substance)?
What types of procedures are involved (X-rays, blood tests)?
What are the possible benefits?
What are the possible side effects?

More Information

The Arthritis Consumer Experts (ACE) have prepared a detailed document which covers many questions you may have regarding clinical trials:
ACE "Frequently Asked Questions About Clinical Trials (139 KB)

For more information regarding participating in a clinical trial, please contact us at: This e-mail address is being protected from spambots. You need JavaScript enabled to view it