Frequently Asked Questions About Clinical Trials?>

What Can I Expect From a Clinical Trial?

Each study is different, depending on the type of treatment at hand. 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 should provide you with information about any medical interventions that will be used during the study, and how the study will be 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 likely receive a complete physical examination.
• Samples, tests, and procedures: The type and frequency of laboratory tests and procedures performed is determined by the nature of the study. You may be asked to take medication orally, subcutaneously or intravenously: provide blood or urine samples for monitoring: or even take place in a surgical procedure.
• Telephone contact: The clinic may occasionally contact you by telephone.
• A stipend: Some studies offer a monetary compensation for your participation. This will probably be given to you during each visit to the clinic. You may receive additional payments for special procedures used to evaluate your health.

What Are The Benefits of Participating in a Clinical Trial?

If you're participating in a clinical trial, you'll likely receive excellent medical care, and be closely monitored beyond what you expect from your general practitioner. You may also:

• Receive early treatment that may help improve your condition
• Have the opportunity to contribute to medical research
• Participate in the trial at no cost, have your expenses covered, and even receive a stipend.

Questions and Answers about Medical Trials

Q: If I sign up for a clinical trial, am I assured of getting the new treatment?
A: 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 often kept secret until the trial is complete.

Q: What happens if I'm given a placebo?
A: The ethics standards followed by clinical trials in the U.S. require that you receive the best medical care possible, even if you're in the control group. So even if you don't receive the experimental treatment, you still receive the best medical care available for your particular condition in the form of close monitoring and regular visits with a specialist.

Q: Can I quit a trial?
A: Yes. You can resign from a study at any time, without prejudice. Obviously, if too many people resign from a study, researchers will have trouble accurately evaluating the treatment at hand. If you resign, you will probably be asked to provide a reason for leaving.

Q: Do I have to give up my doctor?
A: 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.

Q: How long does a study last?
A: 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.

Resources

National Institutes of Health staff. (2008). Glossary of clinical trials terms. Retrieved January 15, 2019, from the ClinicalTrials.gov Web site: http://www.clinicaltrials.gov/ct2/info/glossary.

Pharmaceudical Product Development staff. (2010). What to expect from a clinical trial. Retrieved January 10, 2010, from the PPD Web site: http://www.ppdi.com/study_volunteers/clinical_trial_volunteers/what_to_expect.htm.