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Doctors use a variety of different medications to treat patients who have arthritis and other rheumatic diseases. Before any of these medicines can be prescribed, the federal Food and Drug Administration (FDA) has required strict testing to be sure they are safe and effective at treating a particular disease. Most of this testing and evaluation process is done through clinical trials.
At any given time, dozens of clinical trials conducted by licensed health care professionals are underway. These trials, lasting from a few weeks to many years, determine just how safe and effective new treatments may be. Participating in a clinical trial is completely voluntary, but it isn’t for everyone.
A clinical trial is a research study performed by physicians and other health professionals in which new treatments are tested on volunteers. Safety is always at issue. These studies take place only after laboratory investigations indicate that the new treatment has some potential to be effective and that it seems to be relatively safe. Then, prior to conducting the study on volunteers, an institutional review board (IRB) must approve the safety of each proposed study. The IRB also oversees the study to ensure that all federal regulations that protect human volunteers are being followed.
While participating in such a study, patients with a particular condition (such as rheumatoid arthritis) are given a new medicine and then followed very closely. During follow-up, study personnel again evaluate the safety of the new medicine as well as how well it helps control symptoms.
Many studies are ‘blinded’ to ensure accurate measurement. This means patients taking the study medication may be compared to patients taking another medication or a placebo (an inactive agent, like a sugar pill). Neither the study personnel nor the patients know for sure which treatment is being given.
Doctors regularly provide information about possible risks and benefits of treatments during office visits. However, the information for a clinical trial is much more detailed. In particular, the list of possible side effects for a medicine being tested will often be much longer than for an already FDA approved medicine. Remember, all the risks of the new medication may not yet be known. This does not mean that the medication under investigation is necessarily more dangerous. Instead, this type of detailed disclosure of all possible risks, possible improvements in symptoms, and alternative treatments available ensures patients are fully informed before enrolling in the study. After discussing any questions with the study staff, patients who are willing to participate sign “informed consent.”
Participation in any research study is entirely voluntary. Only patients who have read all of the information and decide to participate on their own are enrolled in clinical trials. Even after enrolling, patients can leave the clinical trial at any time and for any reason. Leaving the study will not affect their normal medical care in any way.
Benefits of participating in a clinical trial include:
Possible risks of participation include:
It is important to remember that patients can leave a study at any time, for any reason. These include intolerable side effects, or if their condition worsens or is not improving. Moreover, many studies in rheumatology include some provision for providing treatment to patients if their condition does not improve, even before the study ends.
A final point to consider—which may be an advantage or disadvantage depending upon the patient—is that clinical trials need more monitoring than standard clinical practice. This means visits to the doctor tend to be longer and more frequent than regular clinic visits.
Clinical trials are limited not only to a particular condition, such as rheumatoid arthritis (RA), but also to people who meet carefully defined criteria. For example, some trials may only be for RA patients who are taking a specific medication, whereas other trials may exclude patients taking that medication. To accurately assess whether a new medication is effective in helping arthritis, many studies enroll only patients who have a certain level of disease activity (e.g., counting the number of joints affected, looking at lab test results, and asking specific questions). Clinical trials may also exclude patients with other illnesses that might adversely affect health and interfere with an accurate assessment of the study medicine’s safety.
The best way to find out about clinical trials in rheumatology is to ask your rheumatologist, who can answer your questions and refer you to appropriate trials. Information about clinical trials can also be found on reliable websites, such as www.clinicaltrials.gov.
Rheumatologists are specialists in the diagnosis and care of patients with various musculoskeletal disorders. A number of rheumatologists also serve as investigators for clinical trials, especially for newer treatments. Even those who do not actively participate in clinical trials are familiar with many of the potential risks and benefits of participating in trials. You may always talk to your doctor if you have any questions about clinical research.
Written by Arthur Kavanaugh and reviewed by the American College of Rheumatology Committee on Communications and Marketing.
This information is provided for general education only. Individuals should consult a qualified health care provider for professional medical advice, diagnosis and treatment of a medical or health condition.
© April 2015 American College of Rheumatology
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