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6 Advancing Research for Infection-Associated Chronic Illnesses
Pages 61-78

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From page 61...
... (Marston) • The ability to generalize Lyme disease research can be signifi cantly affected by applying too narrow of inclusion criteria.
From page 62...
... (Geng) • Studies of diagnostic assays demonstrated that there must be a persistent viral infection or viral reservoir that is continually producing the spike protein.
From page 63...
... Marston stated that the role of FDA is to spur patient engagement, explore innovation in clinical trials and provide feedback to researchers, facilitate considerations of viable endpoints, and support the collection of additional types of data, such as real-world evidence. Elaborating on patient engagement, she emphasized that patients are experts in their conditions, and their input is needed early in the drug development process.
From page 64...
... , introduced herself as a person living with long COVID since March 2020 who has been fighting for the advancement of infection-associated chronic conditions research and long COVID research over the last 3 years. She shared some of the work and recent findings from PLRC and a vision of what a patient-driven research agenda might look like.
From page 65...
... As time went on, more people became infected with COVID-19, but many of these patients with persistent symptoms were not getting better, she shared. PLRC continued gathering evidence from the growing patient community and demonstrated that many people develop long COVID even after a mild initial infection.
From page 66...
... 2. Accelerating the clinical trials of therapeutics that are most impor tant for the patient community.
From page 67...
... Democratizing research requires a change in the system, he said, such as using technological tools to help collect samples from home, centralizing tools, and removing barriers preventing people from participating. Patient organizations play a unique role in providing insights into the conditions and can also add value to participation in research, helping to recruit patients for clinical trials and ensuring they are well represented.
From page 68...
... MyLymeData Lorraine Johnson, LymeDisease.org and MyLymeData, shared information on her organization, discussing inclusion and exclusion criteria in clinical trials and how her organizations' patient registry data can help in determining generalizability of potential therapeutics. Her teams have enrolled more than 17,000 patients since 2015, with the primary goal to increase scientific knowledge in Lyme disease and use its data to influence public policy.
From page 69...
... Lyme Disease Biobank Liz Horn, Lyme Disease Biobank, continued the conversation discussing well-characterized samples. She explained that Lyme Disease Biobank includes three distinct cohorts: early Lyme disease samples, persistent Lyme cohort, and a tissue bank that includes post-mortem3 samples.
From page 70...
... Discussion The discussion that followed included topics such as standardizing sample collection, using appropriate language in research, the role of patient-driven research, and recognizing the lived experience of patients in workplace settings. Regarding sample standards, Johnson said, so many tools are available today that were not available years ago, and there is even greater opportunity to develop sample standards using big data and real-world evidence.
From page 71...
... This section highlights long COVID patient journeys and diagnostic tools in development, and lessons from human immunodeficiency virus (HIV) and Lyme disease networks.
From page 72...
... Another factor contributing to long patient journeys is limited access to health care, with long months of waiting lists, complex care navigation, misdiagnosis, and poorly defined conditions. Geng noted that it is important to take a broader lens and also look at other postinfection-associated diseases, and even postvaccine conditions.
From page 73...
... . Walt's team believed there is a persistent viral infection or viral reservoir that is continually producing the spike protein.
From page 74...
... , anticoagulants, or fibrinolytics. Deeks noted a clinical trials agenda led by Michael Peluso in which multiple interventions will be examined in a common platform across studies.
From page 75...
... Posttreatment Lyme and New Clinical Trials Network Brian Fallon, Columbia University, presented on the off-label use of medications for Lyme disease, as well as symptoms of PTLDS, underlying mechanisms, prior clinical trials, and the Clinical Trials Network Coordinating Center for Lyme and other Tick-borne Diseases at Columbia University. He referenced the overlap between PTLDS and long COVID syndromes, reiterating that there may be common mechanisms underlying both syndromes.
From page 76...
... Because he is a psychiatrist, Fallon wanted to ensure he was not drawing conclusions on psychiatric symptoms of Lyme disease from a biased sample population. Fallon collaborated with researchers in Denmark using a registry of nearly 7 million people over 22 years to study the connection between Lyme borreliosis and mental disorders and suicide.
From page 77...
... The underlying premise of these studies is that effective treatments have to modify the underlying mechanism of disease, he said, whether that is persistent infection, autoimmune reactions, neural network dysregulation, or a combination. In conclusion, Fallon shared some lessons from Lyme disease and a vision of a research agenda for the future.
From page 78...
... To engage industry to become involved in clinical trials for these chronic illnesses, Walt and Deeks agreed that the COVID-19 spike protein may be an excellent biomarker for long COVID, but Deeks said there is also a need for other surrogate markers for clinical outcomes. That would let researchers measure a biomarker, administer interventions, and then observe the changes in levels (i.e., spike protein)


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