New analysis of real-world data from the largest US Lyme disease registry, MyLymeData, has shown that most persistent Lyme disease (PLD) patients in the US are excluded from clinical trials.
The findings, published by MDPI, analysed more than 4,000 patients and concluded that 90% of PLD patients were prevented from participating in clinical trials due to excessive eligibility criteria. The study co-authors recommended that: “Researchers should be parsimonious when selecting eligibility criteria, using them only when there is a strong scientific rationale.”
Smarter leaders trust GlobalData
The study also found that most exclusions were due to stringent restrictions on coinfections and misdiagnoses of chronic fatigue syndrome, fibromyalgia syndrome and psychiatric conditions. It suggested that relaxing these restrictions could increase PLD patient enrolment from 10% to 64%.
“The way researchers currently design clinical trials excludes 90% of [PLD] patients, resulting in small studies that take too long, cost too much and don’t apply to most patients,” stated Lorraine Johnson, study co-author, CEO of LymeDisease.org and principal investigator of MyLymeData.
“Overly stringent criteria exclude the very patients we need to study, leaving clinicians without relevant findings for their practice,” she added.
The study, ‘Optimizing Exclusion Criteria for Clinical Trials of Persistent Lyme Disease Using Real-World Data’, was funded by the Bay Area Lyme Foundation.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataLyme disease is a bacterial infection caused by Borrelia burgdorferi and transmitted by ticks. Currently, almost two million Americans live with PLD, 72% of whom report either poor or fair health compared to 13% of the general population.
Cases are also rising rapidly across the world – including in the US – as changing climates influence tick population density. The US Environmental Protection Agency (EPA) reports that “warming temperatures associated with climate change are projected to increase the range of suitable tick habitat and are, therefore, one of multiple factors driving the observed spread of Lyme disease.”
According to the Centers for Disease Control and Prevention in the US, Lyme disease incidence in 2022 was 68.8% higher than that during 2017-2019.
Analysis by GlobalData indicates a key and growing market within Lyme disease is tests, the market size for which was $10.6m in 2024 and is expected to see a compound annual growth rate (CAGR) of more than 6% between 2024 and 2036.
GlobalData identified Lyme disease enzyme immunoassay (EIA) tests and Lyme disease western blot tests, as two key market segments, noting that Lyme disease EIA tests accounted for the highest share of the market last year.
GlobalData is the parent company of Clinical Trials Arena.
