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Frequently Asked Questions About Clinical Trials

What Can I Expect in a Clinical Trial?
Each study is different, depending on the type of treatment. If you join a clinical trial you can expect the study to include:

Clinical visits: You'll be asked to come into the study clinic on a regular basis for the duration of the study. Depending on the trial, the number of visits can range from a single visit to multiple consecutive visits.

Informed consent: During your first visit, the clinic will provide you with information about any medical interventions that will be used during the study and how the study is conducted. Once you have read the information and received answers to any questions you may have, you'll be asked to sign the Informed Consent form to indicate that you understand its contents.

Medical history: During your first visit, you'll probably be asked to fill out a medical history form, which will include questions on any health problems you have or have had, any medications you are currently taking, and the health of your relatives.

Physical exam: During your first visit, you will probably receive a complete physical examination.

Samples, tests, and procedures: The type and frequency of laboratory tests and procedures performed are determined by the nature of the study. The following are some examples:

• administration of oral, subcutaneous or intravenous medication
• monitoring of blood and urine samples during therapy
• monitoring of vital signs, such as blood pressure, pulse rate, and temperature
• pregnancy testing, for women of childbearing age
• electrocardiogram (EKG/ECG) during resting or exercise (stress test), long-term Holter EKG monitoring, echocardiography using ultrasound
• questionnaires: personal and family medical history
• surgical procedures.

Telephone contact: The clinic may occasionally contact you by telephone.

A stipend: Some studies offer a monetary reward for your participation. This will be given to you during each visit to the clinic. You may receive additional payments for special procedures used to evaluate your health.

What benefits do I get from participating in a clinical trial?

• excellent medical care, closely monitored and beyond the level of regular care
• the opportunity to receive early treatment that may help improve your condition
• the opportunity to contribute to medical research
• no cost, expenses covered and in many trials a small stipend is offered.
• Am I assured of getting the new treatment?
• Not necessarily. A clinical trial requires that some people receive the experimental treatment and some receive a placebo or the established form of treatment for the condition. Who is selected for each group is determined randomly and the information is kept secret, often until the trial is complete.

What happens if I'm given a placebo?
The ethics standards followed by clinical trials in the U.S. require that you receive the best medical care possible. So even if you don't receive the experimental treatment, you still receive the best medical care available for your particular condition.

Can I receive treatment without knowing about it?
No. The law requires that you give "informed consent" to anything medical that is done.

Can I quit?
Yes. You can resign from a study at any time, without prejudice. Obviously, if too many people resign from a study, it can't adequately evaluate a treatment under study. If you resign, you will be asked to provide a reason for leaving.

Do I have to give up my doctor?
No. Your regular doctor will still look after your general health. The medical personnel from the clinical trial center will also keep your regular doctor updated.

How long does a study last?
The duration of a trial varies from study to study. A study must last long enough to gather good information, but completing the study as quickly as possible is in everyone's best interests.