Lyme Disease Patients Call for Greater Participation in Clinical Trials
Advancing Lyme disease care depends on better research—and that requires greater patient participation.
To date, only a small number of National Institutes of Health (NIH)-sponsored trials have included chronically ill Lyme disease patients. These studies were limited in size and often enrolled patients years after symptom onset, many of whom had already failed initial antibiotic treatment.
Lessons from Multiple Sclerosis Research
Lyme disease patients are not alone in calling for more involvement in research. People with multiple sclerosis (MS) have made similar appeals.
Over the past two decades, more than a dozen disease-modifying therapies have been approved for relapsing-remitting multiple sclerosis (RRMS), supported by large-scale clinical trials involving tens of thousands of participants.
According to Smith, these advances were made possible by broad patient participation. Still, the MS community continues to advocate for deeper involvement in shaping research priorities.
Patients with MS have emphasized the importance of studying outcomes that reflect their lived experience—including fatigue, cognitive dysfunction, and physical disability—measured over time rather than at isolated points.
The Lyme Disease Community Response
The Lyme disease community has echoed this call for more meaningful participation in research.
LymeDisease.org, a patient advocacy organization, developed MyLymeData, an online registry that allows patients to securely contribute their medical data.
Since its launch in 2015, more than 9,000 patients have enrolled.
“The project is a true collaboration between researchers and patients,” said Lorraine Johnson, CEO of LymeDisease.org. “It allows researchers to examine how different subgroups respond to treatment and focuses on issues that matter most to patients.”
Why Patient Participation Matters
Patient-driven data collection offers an opportunity to better understand the variability of Lyme disease and treatment response.
Large-scale datasets may help identify patterns in persistent symptoms, treatment outcomes, and subgroups of patients who respond differently to therapy.
For more on persistent illness after treatment, see Post-Treatment Lyme Disease Syndrome (PTLDS).
Research Funding and Future Directions
The National Science Foundation (NSF) awarded a three-year, $800,000 grant to support research using data from the MyLymeData registry.
This represents a shift toward incorporating patient-reported outcomes into Lyme disease research—an approach that may complement traditional clinical trials.
Clinical Takeaway
Greater patient participation in clinical trials and registries may help advance understanding of Lyme disease, particularly in patients with persistent symptoms. Expanding research efforts remains an important step toward improving care.
Dr. Daniel Cameron, MD, MPH
Lyme disease clinician with over 30 years of experience and past president of ILADS.
Symptoms • Testing • Coinfections • Recovery • Pediatric • Prevention
I am diagnosed with multiple sclerosis first with brain lesions and the whole nine yards with two pages full of severe symptoms. They I had to fight for Lyme disease accurate testing. I am chronically positive. You may test me to find and prove the linkage of both diagnoses! Tr***********@*****il.ca although. I better now after a years treatment. My lesions are still present and have not changed. Go figure. There was an investigation on Alzheimer’s as well.
I am wondering as of recently a human arc program in our Pennsylvania health care systems, have called and told me my little girl, almost ten CDC pos since she was six and proof that it was caught to late to be “cured” this was stated by the IDSA pediatrics at Children’s Pittsburgh Hospital,, I believe his exact words, were; her test will never change… A full western blot… Now they are trying to appy my child for disability the human arc program is a advocacy and they will not tell me just which code,, came up as severe or ongoing… this is what documented her as eligible for the SSD…. They will not specify, and she also has EDS, I wouldn’t or even if this is really a severe problem or will become worse in the future… Now I hear that no one gets approved for Disability for lyme disease,, and they may also require an additional mental health eval.. and I believe she does fine in school, good grades,,, a little bit behind in reading skills but excels at math… I am not sure what to do, they keep pushing us to move forward and wont provide to me exactly why… seeing you are a lobbiest… does this sound correctly, and if I mention the Lyme part will it dodge the disabled part? I am so confused… I also have neurolymeborrelia.. MS. and Lupus due to advanced lyme disease and serious spinal dysfunction… and my little girl I’ve done all in my own capability to try to be sure this does not happen to her… I was finally able to get her a medical grant for 2500 with 3 included and paid I genex tests… and an apt with an llmd… and I’m still not sure of myself that we are going in the right direction with this???? any advice?? Please??
Thanks for sharing hot complicated things can get. The western blot bands can persist after antibiotic treatment. Disability is often determined by function rather than disease. You both need an individualized assessment to determine if either of you would benefit from treatment.