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New clinical trials are underway all around the country and world, studying drugs/devices or other treatments for fibromyalgia pain and other symptoms. This gives men and women more options than what’s traditionally prescribed during a doctor’s visit.
Why Try a Clinical Trial?
- A fibromyalgia clinical trial can be a great place to turn for potential cutting-edge new treatments and care from board-certified medical doctors.
- Some trials provide compensation.
- There is no charge and you don’t need health insurance.
- Your health is monitored during and likely after a trial.
- Research gained from the trial you participate in may help future patients with fibromyalgia.
There are many types of clinical trials. Not all clinical trials are drug-based. Some trials involve complementary and alternative medicine or medical devices. Some involve exercise. Others monitor pain and/or emotions. A trial may involve an injection of new analgesics. Some clinical trials are launched to discover ways to detect, prevent and diagnose different chronic painful conditions such as fibromyalgia. There are a lot of options to choose from.
For many people, just having fibromyalgia and being over the age of 18 makes them a good candidate for a trial. Each trial is different, though. Some clinical trials exclude participants for several reasons, such as taking other medications, being pregnant, or having other health conditions (e.g., a heart condition). Find the one that is right for you.
How to Find Clinical Trials for Fibromyalgia
Two excellent websites to begin your research are Center Watch and ClinicalTrials.gov. There’s also Research Match, which does the digging for you.
Center Watch has been around for two decades and boasts “the largest online database of industry-sponsored global clinical trials actively seeking volunteers.” What’s great is that you can filter results by the phase of the trial and by location. You can add your age and gender to make sure you fit in the inclusion criteria. You can also sign up for email alerts when new clinical trials post.
ClinicalTrials.gov is a website that is part of the National Institutes of health. This government-run site has all types of studies. Right now there are clinical trials for acupuncture, dance therapy, medical devices, and more, in addition to drugs.
Research Match does all the work for you and matches you with other researchers looking for clinical trial volunteers. When you sign up, you’ll have access to studies from 128 institutions. After you register, all you have to do is wait to be contacted about open opportunities.
How to Get into a Clinical Trial
If you’re thinking about participating in a clinical trial, you first need to know what phase trial you are interested in.
Phase I (safety). This is the very first phase of a clinical trial and it explores drug/device safety. It usually lasts a few months. Only a small group of people are selected. You likely will be paid for your time and participation. You may get access to new cutting-edge treatments or therapies. In this phase, researchers are looking to see how the drug acts in the human body, and importantly, assess safety.
Phase II (effectiveness). This phase of a clinical trial can last up to two years. The drug or device or treatment program is usually tested with a placebo drug or customary treatment in a few hundred people. In this phase, some people will get the real treatment and others won’t (they may get a placebo) and it may be impossible to know which one you’re getting. Even the researchers may not be privy to that info.
Phase III (benefits, effectiveness, adverse side effects).Large groups of people are studied (several hundred to thousands) and the drug or device or treatment program has already been studied now for quite some time. At this phase, just as in Phase II, you may get the drug/device or treatment program or a placebo/customary treatment. The next step is FDA approval for marketing and sale. The trial can last for several years.
Phase IV (drugs/devices already on the market). Free access to a treatment already on the market is the advantage at Phase IV. Several thousand people participate. You won’t be getting something new, but something that has been pretty well studied. At this point, the drug/device or treatment program will likely be compared to another treatment. Some participants will get one drug/treatment and others will get a competing drug/treatment. Long-term safety and efficacy is studied.
Five Steps to Clinical Trial Entry
Interested in exploring new treatments for fibromyalgia? Start by taking these five steps:
- Search CenterWatch and ClinicalTrials.gov for trials you may be interested in and register with Research Match.
- Decide what Phase trial(s) you want to apply for.
- Look at where the clinical trial(s) is being conducted. Can you easily travel to the designated location to receive treatment? Is it in your state? Is it in your country?
- Find out about inclusion/exclusion criteria for the trial (age, gender, pregnancy, health conditions, etc.). Find a trial(s) you are qualified for.
- Contact the researchers (usually by email or phone) for trials you are interested in. Contact info is listed with the clinical trial details.
Clinical trials can be an excellent way to get new treatment for fibromyalgia. With one caution, however: Despite how much a drug/device has been studied, there can still be side effects and adverse events—in some cases, even life-threatening events. At the same time, there can be benefits that exceed your current treatment. Weigh the risks with the benefits, and involve your doctor with your decision.
Article reviewed by Dennis C. Ang, M.D., M.S., Section Chief, Rheumatology and Immunology
Associate Professor, Rheumatology and Immunology at Wake Forest Baptist Health in North Carolina
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