What Is A Clinical Study?        

A clinical trial is a study done by researchers to test the safety and effectiveness of new investigational drugs and vaccines, devices, or procedures. Clinical trials that research new treatments, new drug combinations, new kinds of radiation therapy, or new surgical procedures are clinical treatment trials.

Clinical trials are necessary steps in the process of making new drugs available to patients. These research studies, which allow pharmaceutical, biotechnology, medical device companies and the government to determine the safety and effectiveness of new compounds, are essential for the advancement of medical science.

Why Are Clinical Trials So Important?

Almost all medications available today have gone through a clinical trial. We now have effective treatments for hundreds of diseases directly due to patients participating in clinical trials.

What Can I Expect When I Participate In A Clinical Treatment Trial?

In a clinical treatment trial, researchers may study the safety and effectiveness of new investigational drugs. Some patient volunteers may take an inactive drug which is called a placebo. You will not know if the drug you take is actually medication or a placebo. Whether you are taking the investigational drug or the placebo, it is important to remember you will be under a doctor's care.

An informed consent document will be presented to you which includes more detailed information about the study, as well as potential benefits and possible risks associated with the research.

Government health authorities and medical ethics groups will oversee the study and you will be monitored by the research team because your health and well being are of utmost importance. You are free to leave the clinical trial at any time.

As a clinical treatment trial volunteer, you may be asked to:

• Regularly visit a healthcare provider
• Take study medication as directed
• Have laboratory and diagnostic tests
• Change your diet and exercise habits

Who Can Participate In A Clinical Trial?

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principal of medical research that helps to produce reliable results. The factors that allow someone to participate in a trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of disease, and other medical conditions. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants.

What Are The Benefits & Potential Risks In A Clinical Trial?

Participating in a clinical trial may have benefits but there are also risks. Clinical trial participants may have side effects, which are sometimes serious, from study medication. Study treatment and evaluations may require more time than standard therapy. Also, there are no guarantees that the study treatments will work.

However, clinical trial participants may be able to gain access to research treatment that is otherwise unavailable, and may help others by participating in medical research. Clinical trial participants may also have access to study medication, medical care, and laboratory services, all at no cost. Additionally, you may also receive monetary compensation for your time and effort.

You should carefully consider and talk with your doctor about the potential benefits and risks of participation before enrolling in a study.