What is a Clinical Trial?
A clinical trial is a medical research study using human volunteers to determine if new methods of human disease management are both safe and effective. Many of the medicines and procedures that are commonly used today are possible because of clinical trial research done in the past. The federal government has established regulations to ensure the safety of clinical trial volunteers including the requirement that trials be conducted under the guidance of a medical institution and that they are monitored by the Institutional Review Board at that entity.
Clinical trials known as treatment trials are used to test the safety and effectiveness of new drugs or devices and treatments. Prevention trials are used to test new approaches to prevent disease, such as new vaccines. New ways to detect disease are tested in detection trials and quality of life trials are used to test new ways to relieve stress and improve comfort and quality of life for individuals with chronic or terminal diseases.
Clinical trials rely solely on voluntary participation. How do you know if a clinical trial is right for you?
Is a Clinical Trial Right for You?
There are significant benefits and risks to participating in a clinical trial. And, as clinical trials have very specific eligibility requirements based on the nature of the study, every clinical trial is not right for every potential volunteer. Prospective volunteers are evaluated on the basis of the eligibility requirements. You should also make sure you completely understand what participating in the study would mean for you. See Questions to Ask to learn more.
Benefits and Risks for Participants
When participating in a clinical trial, you will continue to receive care from your personal physician. In addition, your health will be monitored by the local team involved in the clinical trial. You may also have access to certain new drugs, devices or treatments before they are available to the public. And, you will have the satisfaction of knowing you are helping others by contributing to medical research. These studies are absolutely essential for the development of new drugs, devices, treatments and procedures that will make a difference in the lives of those suffering from disease.
All clinical trial participants are protected by federally-regulated human protection safeguards as well as the ethical and legal codes that govern medical practice. To learn more about these protections, click here.
There are risks, however, in being part of a clinical trial including side effects from the treatment, the possibility that the treatment may not be effective and the possibility that treatment as part of a study may involve more time and attention, including trips to the study site, more treatments, hospital stays or complex dosing requirements. Your participation in a clinical trial is completely voluntary, be sure you understand the requirements thoroughly before you agree to be a subject.