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 trials 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.
Clinical trials 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 withdrawal from the study.
There are no medical trials 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.
People like you participate in research studies for a variety of reasons. Often they are seeking and 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.
Before participating in a trial volunteers must meet specific criteria. The criteria are based on various factors, not limited to but including age, medical history, current health status, current medications, and allergies. The circumstances that allow one to participate are called Inclusion Criteria and those that prevent participation are called Exclusion Criteria. These Criterion are used to ensure the accuracy of the trial as well as the safety of all participants.
Specific details of your involvement in a clinical trial are largely dependent upon the purpose and type of trial you participate in. The research team working with you will give you specific instructions for your trial. Volunteers will have a check-up before beginning the trial, be observed during the trial, and have a visit following their completion of the trial. Some trials will include more office visits than a patient not involved in a trial would normally have.