Clinical trials are research studies aimed at finding new treatments – and even a cure – for certain diseases, in our case, lupus. Studies answers scientific questions, compare new treatments to standard treatments, and search for better ways to treat and diagnosis a disease.
Clinical trials are conducted by protocol, an action plan that details what will be accomplished and how it will be accomplished. Protocols are monitored by independent committees of physicians, statisticians and, in some instances, community members, to ensure that risks to study participants are small – and that any risks are worth the potential benefits.
Trials on humans usually occur only after extensive laboratory and animal testing.
Lupus clinical trials are growing in numbers, after being scarce to non-existent in the recent past. Advances in the understanding of why autoimmune diseases attack the body in the way that they do, clinical trials, most drug-based, have taken root and are making progress.
Patients in clinical trials are often treated by top doctors, researchers and scientists in the field. Treatments may be state-of-the-art, and are certainly standard care. But because it is not known if the new treatment is as good as, or better than the standard, predicting whether a patient will personally benefit from their participation cannot be done.
Joining a Trial
If you are interested in joining a clinical trial, the first thing you should do is talk to you doctor. Provide her or him with all of the information about the trial and its protocol. Your doctor should be able to determine whether the trial is compatible with your treatment plan, how to adjust your plan so that you might participate, or suggest that you decline joining the trial.
Make sure you understand the trial protocol as well, including who will be paying the bill for treatment. Often, insurance companies will treat the study as standard treatment. Sometimes the study will pay for most, if not all, of the treatment. And in some instances, the patient could be asked to pay a portion of treatment costs. Check with the study coordinator and your insurance company to avoid any surprises.
Understand that for various reasons you may be ineligible to participate in the study. Every trial has “inclusion” and “exclusion” criteria that determine who can participate. This might include age, race, geographic region, stage of disease, other medical conditions, type of lupus and so on.
Finally, if you choose to be in a study, consider the commitment you are making. As a volunteer, you have the opportunity to drop out of the study at any time, and may find good, compelling reasons to do so. But understand that your participation is important to the research. Dedicated volunteers always make the best volunteers.
Finding Trials
Here’s a list of online sources for lupus clinical trials:
- U.S. National Institutes of Health Clinical Trials (enter search term "lupus.)
- Lupus Together’s List of Clinical Trials
- Centerwatch’s List of Lupus Clinical Trials
Sources: What is a Clinical Trial? Lupus Research Institute. May 21, 2008
Clinical Trials. National Institutes of Health. May 19, 2008.
FAQ for Patients Radiation Therapy Oncology Group. May 21, 2008.
