Lyme disease, particularly with chronic or late-stage symptoms, can be a horribly frustrating and debilitating illness. Symptoms can persist despite complicated treatment regimens; therapies that seem successful at first may become less effective over time; and medications that work for some appear to have no effect for others. Add to that the high cost of treatment, the complicating challenges of co-infections, and insufficient insurance coverage for both traditional and alternative treatment, and it quickly becomes apparent why clinical studies offer potential for patients who are still suffering.
For many patients, the promise of participating in a clinical trial is not just the hope for new discoveries but a more immediate opportunity to access treatment options they may not otherwise be able to secure or afford. But is clinical research the “holy grail” for these patients who are seeking another option? What are the pros and cons of clinical research? What do you need to know?
What is a clinical trial?
A clinical trial refers to any research study that is intending to evaluate the impact of one or more health-related interventions (treatments, procedures, devices, behaviors, etc.) on health outcomes, in this case Lyme disease. Often these studies involve experimental therapies not yet approved by the FDA with the intention of documenting safety and efficacy and determining the correct dosage. Studies may be randomized with patients prospectively assigned to either treatment or control groups with defined protocols, methodologies, and analytic requirements.
Access to Treatment?
Patients that participate in clinical research usually receive a high level of clinical care and are carefully monitored throughout the trial period. Some studies involve normal “control” populations so not all patients will receive the same treatment but all participants can be assured that their care and disease progression are being carefully evaluated. It is also important to understand that not everyone is eligible to participate in any study. There may be specific health factors that are either critical to the evaluation and/or that could impact participant safety which will then inform who is or isn’t eligible.
Is there a Cost?
Typically research participants are treated free of financial charge and that may include related testing and evaluation to monitor the condition. Treatment is not entirely “free” in the sense that there are specific rules for participation that may include the completion of questionnaires or journals, interviews, and/or testing and failure to comply can result in a patient being terminated from the study. In some cases, there is compensation provided for these additional activities though in most situations funding is limited and collaboration simply expected as part of the patient’s commitment to the study.
What about Safety?
Probably the biggest and most common concern about participating in research is the safety of doing so. If treatments have not yet been government-approved, are they safe? Human clinical testing is the final stage of development for new treatments and treatments have typically been previously examined in the lab, in animals and potentially in other clinical studies. However, all studies and treatments involve some risk. Studies are overseen by Institutional Review Boards, made up of recognized experts in the field, who are charged with overseeing the management of the study to ensure that it is both rigorous and in compliance with appropriate safety protocols. Participants in any research study are given consent forms outlining the risks and benefits of the study/treatment and often, related alternatives. Primary care providers should also be consulted when considering participation in a trial as your regular doctors have the greatest visibility to your full health profile and history and can identify other risk factors.
Logistics – How do I find out about Active Research?
Most studies are conducted by research institutions and/or pharmaceutical companies and do require patients to commute to the research venue for testing or monitoring so you will want to start with exploring opportunities in your area. Where to find out about ongoing research? The US government maintains a database of clinical studies (clinicaltrials.gov) that includes both publicly and privately supported research around the world. The World Health Organization (WHO) also maintains an International Clinical Trials Registry Platform (ICTRP) that is designed to serve both researchers and patients. CenterWatch is a private entity that also compiles information on clinical trials actively recruiting patient volunteers (as well as related resources) and has one of the largest databases on the internet. Finally, some research entities maintain their own websites and have more information about upcoming trials how to be considered for these studies so that is a great place to start if you are focused on a specific geographic area.
Clinical research is critical for the development of desperately needed new diagnostics and treatments for Lyme disease. Without these trials, we will not have new advances in how to approach this rapidly growing epidemic. They may also offer an important treatment alternative for some patients who know and understand the risks.
You may wish to consult the National Institutes of Health (NIH) website for more information about protocols, procedures, and risks.
For information about an upcoming Bay Area Lyme-supported clinical trial, click here.
I, too would participate in a trial. Are there any med schools, research clinics I the Houston area that are going to conduct trials? If there are, please contact me.
I’d also like to be involved in the the government committees working on Lyme disease. Could you give me information on how to get involved if possible.
I’m interested in participating in the clinical trials. I have a very severe and complicated case that has frustrated all of my doctors. I’m a nurse so, of course, I’d like to help my profession be able to better treat and even just understand Lyme disease, if possible. I also treat Lyme patients with my father when I’m healthy enough — which I haven’t been for almost two years due to a medication error that has ruined my life and has proven to be unfixable so far, which has also frustrated every doctor I’ve seen. If something experimental can fix what the drug did, I have several patients that have also been injured by the same drug that are desperate for help too. I’m willing to be a guinea pig for them too.
My husband and I are interested in the clinical trials. I’ve called, left messages and emailed. Please let me know if there’s a way to be involved in these testing. God bless!!!
Thank you. We’ve passed on your interest and information to the team involved in the Combination Therapy research. Unfortunately there is no FDA-approved clinical trial for this treatment at this time though we have formed a multidisciplinary working committee to establish common protocols, held a national summit with government authorities in Washington, DC, and expanded the number of combination compounds under consideration (for more information about the status of this initiative, click here).
You may want to speak to your doctor about alternative treatment options and your interest in participating in some clinical trials; he/she would be best equipped to advise you about appropriate alternatives. You can also find a list of active studies in the US on the federal site clinicaltrials.gov. Best wishes!
How can I find information about the study of Lyme Disease and POTS that was done at Stanford University ?
Here’s an article from Stanford Medicine that may answer some of your questions.
Thora: I am also interested about the Lyme Disease and POTS that was done at Stanford University. Unfortunately, I don’t have any leads on it. You and I have talked on the phone in the 1990’s about Chronic Lyme disease that my wife, Stephanie has had since the 1960’s. She lost her job as a Naturalist at EBRPD in 1989 and I lost my job as a Ranger/Naturalist in 2014 because of Chronic Disseminated Lyme disease. Steve Diers