Real-world data from the largest U.S. Lyme disease registry, MyLymeData, shows current clinical trials for persistent Lyme disease (PLD) systematically exclude most patients who are clinically diagnosed with the condition. A groundbreaking analysis of over 4,000 patients reveals that 9 out of 10 people with PLD are barred from participating in clinical trials, primarily due to outdated eligibility criteria.
The impact is severe. Nearly two million Americans live with PLD, with 72% reporting poor or fair health—compared to just 13% of the general population. These patients also face elevated suicide risk.
Key findings:
Most exclusions stem from co-existing tick-borne infections or previous misdiagnoses of chronic fatigue syndrome or fibromyalgia
Relaxing unnecessary restrictions could increase patient enrollment from 10% to 64%
This is the first real-world data analysis of PLD trial criteria, despite FDA’s 2018 recommendation to broaden eligibility across all medical research
The study, „Optimizing Exclusion Criteria for Clinical Trials of Persistent Lyme Disease Using Real-World Data,“ was funded by Bay Area Lyme Foundation.
