MS and Lyme disease patients call for more participation in clinical trials

Patient advocates have long been involved in lobbying for patient rights and providing outreach and educational awareness of their disease. In the past, “Trials were conducted on their behalf, often without incorporating the needs and views of the participants, and rarely were the results of the trials shared with the study participants,” states Smith in an article published in the Multiple Sclerosis Journal. [1] But times are changing and patients' voices have grown louder as they demand more involvement in research and clinical trials.

It is clear that more patients need to be involved in research and clinical trials if we are going to advance our understanding of Lyme disease and improve patient care. Only 4 clinical trials, sponsored by the National Institutes of Health (NIH) have included chronically ill Lyme disease patients. These trials were small and typically included patients 4.7 to 9 years after onset of symptoms and who had already failed initial antibiotic treatment.

Lyme disease patients are not alone. People with multiple sclerosis (PwMS) have called for more involvement in clinical research. And while there has been progress in developing new drugs to treat MS, patients want to be active collaborators, working with researchers to help develop treatments more quickly.

“In the past 23 years, over a dozen disease-modifying treatments have been approved for relapsing remitting multiple sclerosis (RRMS),” writes Smith from KES Business LLC in Lyme, CT. [1] There have been thousands of participants in these multiple sclerosis trials.

“All of these development programs,” says Smith, “required the participation of tens of thousands of people with multiple sclerosis (PwMS) in clinical trials.” But many more will need to be recruited, she adds.

The PwMS community is asking for just that – more involvement.

“The MS community [should] engage patients’ deep insights into the experience of living with MS to identify those measures which most realistically measure the things they care about and which can have potential to provide clinically meaningful information.” [1]

“PwMS can describe the outcomes and functions that are most important to them such as the multifaceted aspects of physical disability, fatigue and cognitive issues, and the need to measure these aspects continuously, rather than as snapshots in time.” [1]

The Lyme disease community echoes the same calls to action and inclusion., a non-profit patient advocacy organization, has developed a tool that allows patients to securely enter their medical data in an effort to accelerate research efforts. MyLymeData, an online registry, has enrolled more than 9,000 patients since its launch in November 2015.

“The project is a true collaboration between researchers and patients — the first of its kind in Lyme disease,” according to Lorraine Johnson, CEO of, the non-profit organization that developed the database. [2]

“This allows researchers to examine a vast collection of data and look at how subgroups of patients respond to different treatment approaches,” she says. “It is the first patient-centered research conceived by Lyme disease patients, run by patients and focused on issues that patients care about.”

[bctt tweet=”MS and #Lyme disease patients share same desire to be more involved in research and clinical trials. #MyLymeData paving the way. ” username=”DrDanielCameron”]

The National Science Foundation (NSF) recently awarded a three-year, $800,000 grant supporting research that will use data collected by the MyLymeData patient registry.



  1. Smith, K., The evolving role of people with MS in clinical research-Some progress but more is needed. Mult Scler, 2017. 23(12): p. 1579-1582.
  2. Johnson, L., National Science Foundation awards $800K to researchers using MyLymeData., Sept. 19, 2017.

3 Replies to "MS and Lyme disease patients call for more participation in clinical trials"

  • Bambi
    02/27/2018 (4:44 pm)

    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??

    • Dr. Daniel Cameron
      02/27/2018 (8:05 pm)

      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.

  • TrCy
    11/17/2017 (3:33 am)

    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! 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.

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