Revealing the Exclusion of Persistent Lyme Patients from Clinical Trials

Study Reveals Alarming Exclusion of Persistent Lyme Patients from Clinical Trials

In a groundbreaking study utilizing real-world data from the largest U.S. Lyme disease registry, MyLymeData, researchers have found that a staggering 90% of individuals diagnosed with persistent Lyme disease (PLD) are systematically excluded from clinical trials. This revelation raises pressing questions about the efficacy and applicability of treatments currently being researched and tested.

The study analyzed data from over 4,000 patients, unveiling a concerning trend in how clinical trials are structured. As per the findings from the research conducted by LymeDisease.org, most exclusions arise due to outdated criteria that do not consider the complexities of PLD and its co-existing conditions. Lorraine Johnson, the CEO of LymeDisease.org and principal investigator of MyLymeData, emphasized the detrimental impact of this exclusion: "The way researchers currently design clinical trials excludes 90% of patients, resulting in small studies that take too long, cost too much, and don't apply to most patients."

The Reality of Persistent Lyme Disease

With nearly two million Americans affected by PLD, the health implications are dire. According to the research, 72% of these patients report their health as poor or fair, starkly contrasting with just 13% of the general populace. Additionally, these patients face an elevated risk of suicide, underscoring the urgency of addressing their medical needs more effectively.

The analysis sheds light on key reasons why current clinical trial criteria are not reflective of the patient population. A significant portion of affected individuals has co-existing tick-borne infections, previous misdiagnosis of chronic fatigue syndrome, or fibromyalgia. These factors lead to unjust exclusions that deny many patients the opportunity to participate in trials that might provide critical help in their treatment.

The Need for Change

In light of these findings, researchers argue for a reevaluation of the eligibility criteria for PLD trials. Relaxing these constraints could see patient enrollment rise dramatically from a mere 10% to an estimated 64%. This could significantly enhance the scope and relevance of research outcomes, leading to more effective treatments for the majority of those suffering from PLD.

Dr. Raphael Stricker, a co-author of the study, stressed the importance of including PLD patients in clinical trials, stating: "Clinical trials are crucial to finding effective treatments, but they must include the PLD patients that clinicians treat every day. Otherwise, the trials are out of touch with the real world."

A Call to Action

The study titled Optimizing Exclusion Criteria for Clinical Trials of Persistent Lyme Disease Using Real-World Data was funded by the Bay Area Lyme Foundation and emphasizes the pressing need for reform in clinical trial design. The publication adds weight to the FDA's 2018 recommendation to broaden eligibility across medical research, a step vital for practical and altruistic progress in the field of Lyme disease.

LymeDisease.org, dedicated to advocacy and education surrounding Lyme disease, aims to accelerate scientific discovery and improve patient care through initiatives like MyLymeData. Individuals interested in contributing to this cause can enroll in the MyLymeData program or explore findings on the MyLymeData Viz Blog.

In summary, the compelling evidence from this study highlights an urgent need to amend clinical trial eligibility criteria for persistent Lyme disease. By doing so, researchers can better serve the patient community, paving the way for more comprehensive and successful treatment options that reflect the realities of living with Lyme disease.