A clinical trial is a biomedical or health-related research study in human beings that follows a predetermined protocol. An easier way to explain it is that a clinical trial is a scientific study of how a new medicine affects people. It is through this process that the medical community finds new and better ways to treat conditions and illnesses. It is important to note that every new medicine that enters the market has had to go through the clinical trial process in order to be approved by the Food and Drug Administration, or FDA. If a medication does not pass the clinical trial process, it will not be approved by the FDA.
A clinical trial may be interventional or observational. Interventional trials determine if experimental treatments or new uses for existing therapies are safe and effective in a controlled situation. Observational trials address health issues in large groups of people or populations in a non-control situation.
Many different clinical trials are being conducted all over the country, researching oncology, ophthalmology, pain, cardiovascular, central nervous system, dermatology and more.
According to “The Gift of Participation: A Guide to Making Informed Decisions About Volunteering for a Clinical Trial”, the top five reasons people give for participating in a clinical trial are as follows:
• To advance medicine: 51%
• To find a better treatment for my condition: 46%
• To help others with my condition: 39%
• To earn extra money: 36%
• My doctor recommended it: 31%
Participants
Each clinical trial has different guidelines for determining who can participate in their study. These guidelines are often referred to as inclusion/exclusion criteria, meaning certain criteria will either qualify or disqualify a patient from participating. Some studies require healthy volunteers, while other studies require volunteers to have the specific condition being studied. Trials with healthy volunteers are typically done with the purpose of finding out how a medicine affects the human body including how it is absorbed, metabolized and excreted, as well as what side effects may result.
Informed Consent
Informed consent is an essential part of any clinical trial. It is the process of a volunteer learning the key facts about a clinical trial before deciding to participate in a trial. Key information includes a study’s purpose, duration, required procedures, people they can contact with questions, as well as possible risks and benefits of the trial. The volunteer should continue to receive information throughout the trial process. It is important to note that informed consent is not a contract and that a volunteer can leave a trial at any time if they choose.
Side Effects
Side effects are any undesired actions or effects of an experimental drug or treatment. These may include headache, nausea, hair loss, skin irritation or other physical problems. All side effects and adverse reactions of an experimental treatment should be evaluated for both immediate and long-term side effects as this is part of determining the safety and effectiveness of a treatment.
Compensation
Benefits of participating in a clinical trial can include, at no cost for the volunteer, a medical examination relating to the study, an investigational study drug, continual study related care by medical staff and compensation for time and travel involving the study.
