Clinical trials play a vital role in making available new medications and treatments. Before a medication can be made publicly available, an investigational treatment must undergo testing to determine its safety and effectiveness in treating the condition. A clinical trial is a research study in which volunteers receive the investigational treatment under the supervision of a trained, qualified physician. The trial or study is regulated by the Food and Drug Administration (FDA) and overseen by the pharmaceutical company developing the investigational treatment.
Clinical trials are not possible without an individual’s willingness to give of his/her time to volunteer as a participant. Clinical trial volunteers are actively contributing to the development of new medications and therapies that may bring better treatments or cures for diseases or conditions we all may face. With this participation, there are both potential benefits and risks.
- Having access to medical care, procedures, and treatment by the study physician during the trial
- Having access to possible treatments not yet available to the public
- Making a difference in the future medical care for themselves or others
- Unexpected or serious side effects due to the treatment being investigated
- Ineffective treatment that is being investigated
Each clinical trial is different. In some studies, you may receive access to routine medical care, physical exams, treatments, and procedures conducted by a qualified, trial physician and medical staff. As a participant, you may be asked to attend study-related visits at a medical clinic. While in the trial, your health and welfare will be continually monitored. There is no cost for you to participate, and there is no need for health insurance. In exchange for your participation, you may be compensated for your time and travel. All of this information and much more specific information will be thoroughly discussed during your first visit.
Protecting the rights of clinical trial volunteers is paramount in the conduct of a clinical trial. All clinical trials are reviewed and overseen by an independent ethics review board commonly referred to as an IRB. An IRB is made up of doctors, researchers, and other members of the health community. The IRB has the responsibility of reviewing the clinical research trial before it begins and continues to monitor the trial through completion. The purpose of the IRB is to protect your rights, welfare, and safety during a clinical trial. The IRB ensures all who participate are fully informed about the study, that only necessary procedures or tests are performed, the study is ethical, and known potential risks to volunteers are reasonable and explained. You never give up any rights, and as a volunteer, you can decide to end your participation at any time during the study.
Informed consent is a key process that occurs prior to and continues during a volunteer’s participation in a clinical trial. The informed consent process begins with the review of an Informed Consent document that helps to explain the purpose of the trial, what can be expected, potential benefits and risks, alternatives, and how the volunteer’s rights are protected. This also involves open discussions where you are given the opportunity to ask any questions and to receive complete answers to your questions. If, after this discussion and review of the document, you decide to participate in the research trial, you will be asked to sign the document and will be provided with a copy. Informed consent doesn’t end with signing the document. It continues throughout the duration of the trial as you will be updated on newly obtained safety or trial-related information. Remember, as a clinical research volunteer, your participation depends on you providing your personal consent.
To learn if a treatment is safe and effective, it is important to enroll individuals that may benefit from the treatment. To do this, each clinical study has criteria and requirements for participation, and the criteria is different for every study. Age, gender, or medical history are examples of factors that may determine if you qualify for the trial.
Clinical trial volunteers may withdraw or end their participation from a trial at any time. Never forget you are a volunteer. If you do decide to end participation, it is important to communicate this to your study physician to help ensure your safety.
Yes, precautions are taken to protect your personal and health information. Access to your information must be available to the study physician and medical staff. In some situations, the pharmaceutical company conducting the trial or representatives of the company may have access to limited personal information. However, your personal and health information remains protected by the same regulations that protects your medical information held by your own physician. This will be further explained if you meet with our physician about a clinical trial.