What is a Clinical Trial?
A clinical trial is a study of an investigational medication or investigational treatment, in order to see how well it works and to assess its safety. Before a clinical trial can occur, the treatment must have been studied in the laboratory and on animals.
Why do we need clinical trials?
The Food and Drug Administration requires that clinical trials be conducted with investigational medications before it will approve their use with the general public. This is to ensure that the investigational medication is effective and safe.
Who pays for a clinical trial?
Most of the time, clinical trials are paid for, or sponsored, by the company that makes the drug or device being studied. Sometimes, studies are paid for by government health agencies or research foundations looking to treat or cure a certain disease.
Who pays for treatment in a clinical trial?
The sponsor may pay for treatments, such as medication or examinations, necessary for the trial to occur. Also, the sponsor may pay participants for volunteering for the study.
How are my rights protected?
At the start of a trial, you will be given an informed consent form to sign. This is required by law. The consent form describes the purpose, procedures, benifits, risks, discomforts and precautions of the study. Also, before any clinical trial can begin, it must be approved by an Institutional Review Board (IRB). This is a group of doctors, scientists, patient advocates, legal representatives and/or clergy, who make sure there is a good scientific reason for the trial, and that risks to participants are balanced with the potential benefit.
What are the risks?
The trial is designed to evaluate the safety and effectiveness of the treatment, and whether or not there are side effects. There are risks with all clinical trials, which will be described in the informed consent. However, with all investigational medications and treatments, there may be some risks that are currently unknown.
Is my privacy protected?
Participation is confidential, except as required by law. The investigator for the trial may release your medical records to the sponsor and its representatives, and in certain circumstances, the FDA and the IRB. However, any publication of the data obtained in the study will not identify you by name.
What are my responsibilities?
Generally, you will be asked to complete visits with the physician or study manager as scheduled, take the medication as directed, and you may be asked to write down how you feel througout the course of the study. You will be asked to contact the study coordinator at any time if you are hospitalized for any reason. You are, however, free to leave the study at any time.
Benefits to Patients Enrolling in Clinical Trials: