Outcome Measure Validation for Clinical Trials

This project aims to 1) design and develop standard protocols for ME/CFS clinical trials, and 2) develop precision medicine to tailor treatment strategies for patients.

  • Wenzhong Xiao, PhD
  • Jingcheng Yang, PhD
  • Peng Li, PhD
  • Preliminary analysis pipelines are in development as part of the LIFT.

STUDY HYPOTHESIS AND DESCRIPTION

ME/CFS lacks a standard treatment, and clinical trials testing drug candidates are very limited. Many drugs have increasingly been used as off-label treatments for ME/CFS, with anecdotal and/or subjective improvements in patient outcomes. Meanwhile, new candidates for treatments are discovered from ongoing research. Clinical trials are essential to test the safety and efficacy of these treatments.

 

Because of the complex symptoms of and the absence of diagnostic or predictive biomarkers for the disease, standard protocols for clinical trials in ME/CFS remain to be developed to allow evaluation of the efficacy and safety of treatments with high sensitivity and specificity. This project aims to develop these protocols.

Researcher with pipette

OBJECTIVES

  • Establish computational analysis pipelines for wearables and other objective measures to be used in clinical trials.
  • Test and evaluate the performance of objective outcome measures for clinical trials.
  • Test and evaluate the performance of patient-reported outcomes for clinical trials.
Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME / CFS) Post Treatment Lyme Disease Syndrome (PTLDS), Fibromyalgia Leading Research. Delivering Hope.Open Medicine Foundation®

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