| Lyme
disease patients benefit directly from the the research done by Lyme
disease research and practice (LDPR). Through LDPR, they gain access
to clinical trials by the same doctors who are treating them, and they
are often among the first to receive new, proven therapies for their
disease. "We're leading the standard of care" says Dr. Daniel
J. Cameron, a nationally renowned expert in the Lyme disease field who
is director of the Lyme Disease Practice and Research. This primary care setting is uniquely relevant to chronic Lyme disease epidemiology, given the availability of front line personnel treating Lyme disease, the ability to examine the entire cohort of Lyme disease patients, and the potential for conducting rapidly evolving or emergent research. Research in the primary care setting resolves methodologic problems, such as documenting the accuracy of a customary procedure in preparation for use in epidemiologic research (referral bias), or evaluating the effect of Lyme disease diagnosis and/or treatment on risk factor estimates derived from case-control studies. Patients will be drawn from patients identified by the Surveillance Database. This comprehensive cohort improves the generalizability of the result to the general Lyme disease population. The control population drawn from the same primary care practice in an endemic area for Lyme disease allows generalizability to the primary care setting. The
LDPR initiated and is continuing to enroll patients in a clinical trial
treating Lyme disease patients with recurrent Lyme disease with antibiotics
to better understand the role of persistent infection and guide the
development of innovative antibiotic treatment strategies. LDPR'ss office is stategically located in Mt. Kisco, New York. The practice provides primary care, enabling LDPR to comfortably accommodate many types of clinical studies. The staff of the LDPR consists of trained clinicians, researchers, and support staff dedicated to providing the best in patient-oriented clinical research. After
a series of pilots over 5 years, a full scale Lyme disease Surveillance
Database was successfully launched. Over two thousand consecutive patients
with Lyme disease have been added consecutively to the Surveillance Database
since the inception of the cohort in June 1997. History, signs, laboratory
examinations, symptomology, and outcome data have been entered prospectively
on every patient. Pioneering design top The
LDPR initiated and is continuing to enroll patients in a clinical
trial treating Lyme disease patients with recurrent Lyme disease with
antibiotics to better understand the role of persistent infection and
guide the development of innovative antibiotic treatment strategies. LDPR
has introduced "Proof of concept" clinical trials that are
critical in understanding the treatment of chronic Lyme disease. LDPR
is the largest primary care center to offer clinical studies (Phase
IIa) in Lyme disease. These "Proof of concept" studies will
help establish appropriate dosage, duration of treatment, and safety
profile. LDPR provides the research infrastructure for facilitating the research of a community based non-academic practice for a broad array of research on diagnostic testing, treatments, and prevention. The availability of such an infrastructure enables a greater efficiency and breadth in the capacity to pursue intervention research. Expertise will be provided in experimental methodology, database maintenance, statistical analysis, and statistical consultation. This
provides core support for patient recruitment and follow-up, diagnosis
and assessment, data base management and statistical analysis, and laboratories.
Consultation will be proactive and provided to LDPR-affiliated
clinical staff very early in the planning research studies and projects.
LDPR provides the investigator with the necessary support for the initial feasibility testing of innovative clinical treatment studies on Lyme disease. It is expected that this LDPRW will serve as a basis for planning future clinical research project or cooperative clinical trial group studies. This
LDPR envisions piloting new therapeutic clinical trials that
move new treatment strategies more rapidly from the primary care office
into peer review journals. The research facilitated by the Surveillance
Database will have major public health significance including intervention
studies that are broadly inclusive with respect to the heterogeneity
of patients, the severity and chronicity of chronic Lyme disease, and
types of interventions in the primary care setting. These clinical studies
involving human subjects will be designed to ultimately improve Lyme
disease treatment, and be based on a strong rationale. The underlying
hypothesis is supported by preclinical data. The clinical correlates
will have future clinical application such as development of new treatment
strategies or identification of patient subsets for specific treatment
therapies.
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