Study Shows 90% of Persistent Lyme Patients Excluded from Clinical Trials

FacebookFacebookTwitterTwitterEmailEmailLinkedInLinkedInWhatsAppWhatsAppMessengerMessengerFlipboardFlipboardGmailGmailTelegramTelegramShareShare

Research highlights need to expand PLD eligibility criteria to reflect real world data

LOS ANGELES, Jan. 7, 2025 /PRNewswire/ — 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patients reveals that 9 out of 10 people with PLD are barred from participating in clinical trials, primarily due to outdated eligibility criteria.

Excluding 90% of patients results in small studies that take too long, cost too much, and don’t apply to most patients

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.

“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,” states Lorraine Johnson, 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.”

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.

“Clinical trials are crucial to finding effective treatments,” emphasizes co-author Dr. Raphael Stricker, “but they must include the PLD patients that clinicians treat every day. Otherwise, the trials are out of touch with the real world.”

The study coauthors are Lorraine Johnson of LymeDisease.org, Los Angeles, CA; Mira Shapiro of Analytic Designers LLC, Bethesda, MD; Deanna Needell of the University of California at Los Angeles, CA; and Raphael Stricker, of Union Square Medical Associates, San Francisco, CA.

About LymeDisease.org

LymeDisease.org is a national nonprofit dedicated to advocacy, education, and research related to Lyme disease. As the organization behind MyLymeData, the largest patient-led Lyme disease registry in the United States, we work to accelerate scientific discovery and improve patient care.

Additional Resources:

This study can be downloaded here.

To enroll in MyLymeData, visit www.MyLymeData.org .

For more information about findings from the registry, visit the MyLymeData Viz Blog

LymeDisease.org

View original content to download multimedia:https://www.prnewswire.com/news-releases/study-shows-90-of-persistent-lyme-patients-excluded-from-clinical-trials-302343871.html

SOURCE LymeDisease.org

Staff

Recent Posts

Rockefeller Foundation Releases New Polling Data: Majority of Americans Want Food is Medicine Programs

Nearly 80% of Americans think food and nutrition should be covered by insurance to address…

48 minutes ago

TE Connectivity declares quarterly dividend

GALWAY, Ireland, June 11, 2025 /PRNewswire/ -- TE Connectivity plc (NYSE: TEL) announced today that…

13 hours ago

SRM Equity Partners Acquires RF Technologies, a Leader in Safety and Security Solutions for Healthcare and Senior Living

BROOKFIELD, Wis., June 11, 2025 /PRNewswire/ -- SRM Equity Partners ("SRM"), an operationally focused private…

13 hours ago

New Findings from NSC Grant Recipients Help Tackle America’s Most Common Workplace Injury

MSD Solutions Lab programs unite academic researchers and industry partners to drive innovation WASHINGTON, June…

13 hours ago

Version 3.0 AI Automation Platform Launches at VGM’s Heartland Conference

Darby 3.0 automates patient intake workflows from fax to EMR, helping HME providers scale without…

13 hours ago