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Q: What Are Clinical Trials?
A: Clinical Trials, determine if a drug is safe and effective, what doses work best, and what side effects it causes-information that guides health professionals. These drugs must be tested in the kind of people they are meant to help. It is important to design clinical studies that ask and answer the right questions about the products. This process starts with a drug sponsor, usually a pharmaceutical company, seeking to develop a new drug or gain more information about a drug available by prescription. The process appears straightforward-simply recruit groups of patients to participate in a clinical trial, administer the drug to those who agree to take part, and see if it helps them.

Q: Are Clinical Trials Safe?
A: Clinical Trials are conducted in a healthcare setting (a Hospital or Clinic) and are typically monitored by a trained healthcare professional. An Institutional Review Board or IRB approves all clinical trials. This is a committee made up of doctors, Ethicist, and members of the general public and administrators. This Group is held responsible for agreeing that a trial does not represent an unreasonable risk to patients who are participating. Trials are also reviewed by the FDA. Your doctor is responsible for your well being and is the best person to decide whether or not you are eligible to participate in a trial.

Q: Should I participate in a Clinical Trial?
A: There are many reasons people take a part in research studies. Often it gives you a chance to access a medicine that is not available on the market for prescription. If this is the case, you should remember that the study is being performed to find out if the drug works and if it is safe. This means that there is some information in the study that will allow your doctor to find out more about your disease and the effects it has on you. This may allow you to benefit from better treatment after you have completed a trial. A trial may not benefit you directly, but the information gathered may be of help to other patients with the same condition.