What is a clinical study?
Doctors and scientists are constantly discovering new medications and devices that will help prevent, detect, diagnose, control, and treat illnesses. A clinical trial is a scientific study that tests these new discoveries. Clinical studies need the participation of volunteers.
These medications and devices have been tested and found to be beneficial and safe in animals. Before any of these new medications or medical devices can be placed on the market for use by the public they have to be tested multiple times to ensure their safety and efficacy.
What is informed consent?
Clinical studies require the participation of volunteers. To become one of these volunteers you must sign an informed consent. This is detailed information about the study: what to expect, what is expected of you, the risks, the benefits, and the duration of the study. Please read over this document carefully and make sure you ask any questions that you may have. Your Doctor and Research Nurse will also discuss the benefits, risks, and procedures with you. At any point you are free to withdraw from the study.
About Clinical Study Participation
What are the risks?
There are no medical studies that are done without some type of risk, discomfort, or inconvenience. These will of course vary with each study. Prior to the study ever starting, medical professionals and lay people review the study design to minimize the associated risks. Make sure you ask what the risks specific to your study will be.
What are the benefits?
Benefits vary with each study so no guarantees can be made as to which benefits each individual will receive. The following is a list of potential benefits one may receive:
- You may be contributing to the discovery and marketing of new cures and treatments
- You may receive study medication at no charge
- You may receive study related Doctor visits and lab work at no charge
- Your medical condition may improve
- You may receive new treatment not yet available to the public
Why do people become involved in research studies?
People like you participate in research studies for a variety of reasons. Often they are seeking an alternative treatment to those treatments that are currently available to treat their medical condition.
Many research patients take part in studies because they appreciate the close medical care they receive in a research study.
Research Studies also include volunteers who want to advance the medical research process. Patients often feel frustrated and helpless, unable to contribute to their current treatment options. Through participation in a research study their opinions help shape medical options for years to come.
Can I participate in a clinical study?
Before participating in a study, volunteers must meet specific criteria. The criteria are based on various factors including (but not limited to) age, medical history, current health status, current medications, and allergies. The circumstances that allow one to participate are called Inclusion Criteria. Those that prevent participation are called Exclusion Criteria. These criterion are used to ensure the accuracy of the study as well as the safety of all participants.
What happens during a clinical study?
Specific details of your involvement in a clinical study are largely dependent upon the the type and purpose of the study. Your research team will give you specific instructions for your specific study. Generally, volunteers have a check-up before beginning the study, are observed during the study, and have a visit following their completion of the study. Some studies include more office visits than similar cases with patients who are not participating in a study.