Journal of IiME Volume 7 Issue 1 (May 2013) OMI-MERIT INITIATIVE For a long time IiME has argued for a strategic approach to research into ME was necessary. But a translational research model also requires research to be connected to patient care – diagnosis, management, treatments, research integration, follow-up and so on. In such a model we also need researchers to work together. International collaboration is necessary and sharing of common database repositories and protocols. Local area GPs and consultants need to be involved and be able to share experiences. The use of digital technology also needs to be integrated in order to expedite and facilitate research and results. Using new technology also opens the way for severely affected patients to be integrated into research – thus enabling opportunities for them to be able to improve if treatments are found. The OMI-Merit Initiative offers to do all of this and create a surge of awareness which can finally make the urgent and long-overdue leap in progress which has been held back for a generation. Invest in ME wish to play a part in supporting this endeavour. The OMI-MERIT Initiative is a strategic initiative of the Open Medicine Institute and its collaborators to put the best science and people together in an organized, collaborative plan to discover and apply diagnostic and treatment solutions for ME/CFS. Led by the Open Medicine Institute and the MERIT Chair, Dr. Andreas Kogelnik (Open Medicine Institute/Private practice, US), the OMI-MERIT includes already many of the leading clinicians. Leading scientists and clinicians from around the globe with expertise in immunology, virology, genomics, informatics, molecular biology, epidemiology, infectious diseases, oncology, pathology, and clinical medicine – many presenting at IIMEC8 or BRMEC this year including Dan Peterson (Private practice, US), Olav Mella and Øystein Fluge (Haukeland University Hospital, Norway), Sonia Marshall-Gradisnik (Griffith Univ., Australia), Carmen Scheibenbogen (Charité Berlin, Germany), Rosamund Vallings (Private practice, New Zealand) and Mady Horning (Columbia Univ., US). The OMI-MERIT Priority Projects The OMI-MERIT initial projects are as follows – 1) Treatment: Phase 1: A large-scale, randomized, placebo-controlled trial of rituximab and valgancyclovir Goal: This rigorous, four-armed study will examine and further validate two of the most promising Invest in ME (Charity Nr. 1114035) therapies in the field by comparing: placebo, rituximab alone, valgancyclovir alone & combination therapy of valgancyclovir plus rituximab. Exceptional measurements of physiologic, genomic, virologic, and immunologic markers will be made throughout the course of the trial. Importance:A large-scale, rigorous trial is needed to confirm the initial findings of earlier smaller studies and move ME/CFS to molecularly trackable disease. Success of such a trial could move ME/CFS to a mainstream process for additional diagnostic and treatment trials. 2) An International Neuro Registry and BiobankPartially Funded. Goal:Supporting and expanding the largest and most comprehensive, longitudinal ME/CFS information source for research and collaboration will be the result of this project. We will collect longitudinal data and biological specimens from ME/CFS patients and controls and characterize the ME/CFS population by patient symptoms, laboratory and molecular profiles through crowd-sourced informatics and cutting edge tools in immunology, genomics and molecular biology. Comprehensive, standardized, sampling will include blood, CSF, urine, stool, brain/CNS, and other tissues. Samples will be available for additional studies in the MERIT list and beyond. Importance:There has been no large-scale, chronologic characterization effort across the ME/CFS population. The Registry and Biobank will help establish clinical and biologic clusters in the population, paving the way for diagnostic biomarkers and cluster specific treatments. In addition, this will provide a community resource for patients and is central to additional collaborative projects. 3) Protein Panel in Treatment and Naïve Patients Goal:Performing in-depth, cutting edge protein analysis of selected specimens from the Biobank to identify bacteria, viral, hormonal, antibody, cytokine and other protein-based substances that might be present in patient specimens. Specimens will be selected based on expected yield from clinical data and then discoveries confirmed in the larger patient population. Importance:This project aims to apply cutting-edge protein detection systems with specific, ultrasensitive ME/CFS related targets identified. Protein markers are key in identifying potential biomarkers and many new advanced technologies have never been applied to ME/CFS before. www.investinme.org Page 32 of 36
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