Clinical trials or research studies- are organized tests of medicines and new treatment options. These studies rely on patient volunteers who try the new or changed treatment. Sometimes they are new 'experimental' medicines that have not been approved by the FDA for sale in the United States. Sometimes they are drugs that are currently available for sale but are being tested for a new disease or new doses of the same medicine. Not all doctors choose to do clinical trials. You may enter a trial with your own doctor or with another local doctor who is running a trial you are interested in. If you go to a doctor other than your own, you are always free to go back to your own doctor for your routine medical care. Questions relevant to the trial should always be addressed to the trial doctor for the duration of your trial participation. Any clinical trial participation is always voluntary. In most clinical trials the treatment, office visits, and all tests are free. You may also be given financial compensation for participating in some cases. Your doctor or the study coordinator at your doctor's office should share information regarding the compensation package with you during your first visit.
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, ethicists, 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. Whenever you agree to enter a trial you are given the name and telephone number of a contact in your local physician's office who will answer your questions as well as a member of the IRB whom you can contact if you have any doubts.
There are many reasons people take 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 that is unknown about the drug and it is considered experimental. Often the process of collecting information in the study 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. Many patients derive satisfaction from knowing that they are part of the effort to potentially reduce the suffering of other people.
Each trial has certain requirements for participation. Your doctor will take a medical history from you and may request additional testing to determine if you are eligible according to the criteria for the study.
Adapted from Clinicaltrials.com