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What Is Clinical Research?
Drugs and medical devices must undergo extensive testing before they can be approved by the Food and Drug Administration (FDA). Before testing in people begins, laboratory research is done, and typically involves years of experiments in animal and human tissue. If this stage of testing is successful, the manufacturer may apply to the FDA to begin clinical trials.
Clinical trials usually take place over several years and involve hundreds to thousands of volunteers. The results of the clinical trials will provide the manufacturer and the FDA with answers to two important questions: Is the product safe? Is it effective?
A clinical trial may last a few weeks or several years. A study may be “open” (both the physician and the volunteer know what drug is being used) or it may be “blinded” (neither the physician nor the volunteer knows which of the two drugs is being used).
Blinded studies often involve the use of a “placebo” (a substance with no therapeutic value) so that the treatment results between people using the test drug and people using only the placebo can be compared.
A volunteer will always be told if a clinical trial involves a placebo. Usually placebos are used as an addition to other approved drugs that would normally be given to patients for treatment of their disease.
Is Clinical Research Safe?
There are several safeguards for volunteer protection built into the clinical trial process. Clinical trials follow strict FDA-approved plans called ‘protocols.’ The protocol provides the physician with information on how the product must be used, what safety tests will be performed, and how often the volunteer must come to the clinic during the trial.
The FDA also requires the volunteer to be given a detailed document called an ‘informed consent.’ The informed consent tells the volunteer about the study, including:
- That the study involves research on humans
- The purpose of the study
- The length of volunteer participation
- The experimental procedures to be used
- The products that are experimental
- Foreseeable risks or discomforts
- Benefits to the volunteer
- Alternative procedures or treatments
- Who has access to records identifying the volunteer by name
- Compensation, if any
- Procedures to be followed if an injury or accident occurs, and compensation and/or medical treatment available if this happens
- Names of contacts who can answer questions about the trial, explain the volunteer’s rights, and help out in an emergency
- That participation is voluntary and that refusal to participate will in no way involve penalty or loss of benefits to which the volunteer is otherwise entitled
- That participation may be discontinued by the volunteer at any time without penalty or loss of benefits
A volunteer has the right to know as much information about the trial as is necessary to make a decision to participate. Therefore, volunteers are encouraged to ask the doctor and the research staff questions or to provide more details.
Review of the protocol by an Institutional Review Board (IRB) is another safeguard. The IRB, which is composed of physicians, scientists and lay people, helps determine that the study poses no unnecessary risks to the volunteer.
Should I Participate?
People participate in clinical trials for many reasons. Volunteers can gain access to promising drugs and medical devices long before they are approved for the marketplace. Also, in drug trials, the product is typically supplied to the volunteer at no charge. And, as stated above, there is usually no charge for study-related exams, tests and procedures.
Some people volunteer because they enjoy being at the forefront of new technologies. Others participate for humanitarian reasons - helping to gather information on diseases, drugs and medical devices that could potentially impact the lives of millions of people. Each person must decide if enrolling in a clinical study is right for him or her.
Who Pays For Clinical Research?
Clinical research is funded by both the government (through the National Institutes of Health) and by private drug and medical device manufacturers. The institution paying for the research is called the ’sponsor.’ The sponsor hires physicians to conduct clinical trials who are usually paid on a per-patient basis. The sponsor pays the physician to gather information about the drug or device by performing study-related exams, tests and procedures.
A volunteer’s usual and customary medical exams, tests and procedures not related to the study are paid for by the volunteer or other third-party payer (such as an HMO, insurance company or Medicare), just as they would be if the volunteer was not in a clinical trial. All tests, procedures and exams that are being done just for the trial and are not part of normal treatment, are paid for by the sponsor.
Your doctor will be glad to discuss participation in clinical trials and answer any questions you may have. He or she may refer you to the doctor in charge of a study, called the ‘principal investigator.’ You can also call the Urology Associates of North Texas Clinical Research department, which is staffed by nurses and other healthcare professionals, at (817) 465-8715 ext. 108 during normal business hours. The Clinical Research department can give you information about current studies or you may register to be notified about future clinical trials. Of course, you are under no obligation to participate.
If you have access to a computer and the Internet, you can find thousands of websites providing information on clinical research, pharmaceutical and medical device manufacturers, and the FDA.